This presentation will provide a comprehensive knowledge on current UDI labeling standards and how medical device companies can implement the best practices to assure compliance.
FREYR UDI VISION SERIES SESSION 1 - UDI READINESSFreyr Solutions
Very few device manufacturers have experienced the impact and challenges faced during UDI compliance. A very crucial aspect being aware and assessing the level of UDI readiness, implementation of appropriate standards, feasible technologies and ultimately achieving UDI compliance is a major task.
As per FDAs UDI final ruling, GUDID will accept only DI information and it is the responsibility of the medical device manufacturer to maintain the PI information for any future regulatory and quality audits
If you are selling medical devices in the US, your devices are subject to new regulatory requirements under the FDA Unique Device Identification (UDI) rule.
UL experts have been actively working with customers with gap assessments, project planning and more to support compliance with these requirements. In this webinar, Ms. Linda Chatwin, RAC will be sharing some of our key learnings.
UL offers a full suite of services to support compliance with FDA's UDI Rule.
For more information, please contact us and request a sell sheet at Medical.Inquiry@ul.com, visit our UDI webpage or speak directly with one of our experts at 1-877-854-3577 or +91 804 138 4434
http://industries.ul.com/blog/us-fda-unique-device-identification-udi-implementation-deadline-in-place-for-medical-devices
Leveraging UDI Database Requirements to Drive Data GovernancePTC
Delivered at the event “UDIs and Traceability for Medical Devices 2014” in Munich, May 21 – 22, 2014, Europe's only UDI-dedicated event for the medical device industry – with keynotes from the FDA and European Commission– this slideshare presents a Solution Provider’s perspective on the impact of Master Data on the UDI submission to the FDA UDI data base. In detail, the presentation highlights the following subjects:
- A checklist for compliance – What to consider when selecting a solution for UDI data submission
- Data management as a lever for streamlined submissions – Current situation, challenges, and best practices for establishing data governance within an organization
- How PTC solutions support UDI and data governance – PTC’s UDI solution and the broader approach for central product data management
FREYR UDI VISION SERIES SESSION 1 - UDI READINESSFreyr Solutions
Very few device manufacturers have experienced the impact and challenges faced during UDI compliance. A very crucial aspect being aware and assessing the level of UDI readiness, implementation of appropriate standards, feasible technologies and ultimately achieving UDI compliance is a major task.
As per FDAs UDI final ruling, GUDID will accept only DI information and it is the responsibility of the medical device manufacturer to maintain the PI information for any future regulatory and quality audits
If you are selling medical devices in the US, your devices are subject to new regulatory requirements under the FDA Unique Device Identification (UDI) rule.
UL experts have been actively working with customers with gap assessments, project planning and more to support compliance with these requirements. In this webinar, Ms. Linda Chatwin, RAC will be sharing some of our key learnings.
UL offers a full suite of services to support compliance with FDA's UDI Rule.
For more information, please contact us and request a sell sheet at Medical.Inquiry@ul.com, visit our UDI webpage or speak directly with one of our experts at 1-877-854-3577 or +91 804 138 4434
http://industries.ul.com/blog/us-fda-unique-device-identification-udi-implementation-deadline-in-place-for-medical-devices
Leveraging UDI Database Requirements to Drive Data GovernancePTC
Delivered at the event “UDIs and Traceability for Medical Devices 2014” in Munich, May 21 – 22, 2014, Europe's only UDI-dedicated event for the medical device industry – with keynotes from the FDA and European Commission– this slideshare presents a Solution Provider’s perspective on the impact of Master Data on the UDI submission to the FDA UDI data base. In detail, the presentation highlights the following subjects:
- A checklist for compliance – What to consider when selecting a solution for UDI data submission
- Data management as a lever for streamlined submissions – Current situation, challenges, and best practices for establishing data governance within an organization
- How PTC solutions support UDI and data governance – PTC’s UDI solution and the broader approach for central product data management
12 Steps for Medical Device UDI Submissions to the FDA GUDIDJoe Hage
UDI regulations kick in for Implantables and Class II devices in 2015.
Reed Tech subject matter expert Gary Saner is my go-to on this subject. He covered:
• Requirements of a GUDID submission system
• Process steps in selecting/launching a GUDID system and making submissions
• Data Fields – including those that are problematic
• Data Cleaning, Harmonization, and Validation tips
• Update on FDA’s changing GUDID guidance, e.g., convenience kits and implants
• Notes in setting up a FDA GUDID account
RELEVANT FOR:
• UDI Team Leaders/Members
• Regulatory Directors/Managers/Staff
• Manufacturing, Operations, and Supply Chain Logistics Personnel
• UDI IT Support Personnel
• Compliance Officers
• Distributors with UDI Submission Responsibilities
Video at http://medgroup.biz/UDI-in-2015
Unique Device Identification: Manufacturer, Hospital and Global ImplicationsApril Bright
Unique device identification (UDI) is gaining global adoption. Now is the time for companies to take a step back and ask: Is my UDI framework scaleable? UDI experts answered questions on the U.S. regulation and provided perspective on ways that device manufacturers can implement a working system—including data management—that can scale with product development and UDI compliance needs. Attendees gained an understanding of new global regulations and practical, implementable advice for compliance.
Global unique device identification database (gudid) and udiJoe Hage
Medical device companies are affected by the Unique Device Identification ruling from FDA. UDI experts Reed Tech help members of the Medical Devices Group understand the complexities.
You can find the audio replay and transcript at http://medgroup.biz/unique-device-identification
Changes in the pipeline for the traceability of medical devices and equipment. Unique Device Identification, Global Medical Device Nomenclature, barcodes and more!
Implementing a Global Unique Device Identification (UDI) Solution: Regional U...Greenlight Guru
UDI data requirement experts Gary Saner and John Lorenc of Reed Tech will discuss best practices for UDI preparations and the future potential impacts to medical device manufacturers as global health authorities publish mandates.
This session will give suggested best practices concerning EU EUDAMED preparation, what we have learned via testing and a Q&A session. Bring your specific questions concerning medical device registration scenarios, data elements and requirements. The speakers will review and provide clarity on currently posted guidance and answer your questions concerning EUDAMED and other health authority timelines.
This presentation originally aired during the 2021 State of Medical Device Virtual Summit.
Prioritizing Documentation for MDR Transition PlanningGreenlight Guru
This session will discuss the one year delay of the MDR date of application as well as some strategies to employ during the MDR Transition. In addition, some approaches for determining documents to prioritize for the transition will be discussed.
This session took place live at the Greenlight Guru True Quality Virtual Summit, a three-day event for medical device professionals to learn to get their devices to market faster, stay ahead of regulatory changes, and use quality as their multiplier to grow their device business.
This short presentation is giving a brief introduction of the general status of china medial device industry, as well as an explanation about the CFDA and the medical registration process in china
Unique Device Identification or UDI is a forever project. What's the best way for orthopaedic device companies to receive return on their investment? What best practices can be learned for a continually-smooth process? How can the data be leveraged to enhance your company’s value proposition? The true value of UDI is not in the identification number, but in the data that can be generated as a result of UDI. This session will provide attendees with an outline of the opportunities that manufacturers can leverage beyond implementation.
On September 24, 2013, the U.S. Food and Drug Administration announced the new requirement to identify medical devices that affect its safe and effective use through the use of UDI. Explore on how Freyr can help medical device companies achieve UDI compliance.
How User Experience Design and Human Factors Engineering can Accelerate Produ...Greenlight Guru
A growing number of medtech companies are embracing User Experience (UX) Design and Human Factors Engineering (HFE) — not just to meet FDA regulations, but also to create more intuitive, more usable, and holistically better products. These practices required to promote safety and efficacy also provide an opportunity for your company to quickly deliver products that are more innovative, which can be a key differentiator in the competitive medical device market.
This session will answer the questions: what is Human Factors Engineering and why is it important? We’ll also cover:
• Human Factors guidance and regulations
• Human Factors Engineering process overview
• Differences between regulatory usability and UX
• How to use UX to feed regulatory development
This session took place live at the Greenlight Guru True Quality Virtual Summit, a three-day event for medical device professionals to learn to get their devices to market faster, stay ahead of regulatory changes, and use quality as their multiplier to grow their device business.
8 Steps You Should Be Taking to Implement an EU-MDR Compliance ProgramGreenlight Guru
The new MDR will affect all Medical Device manufacturers.
The availability of the text for the new European Medical Device Regulation allows manufacturers to start the process of assessing the impact it will have on their activities, and what they will need to do to be compliant with the revised requirements.
The MDR will overhaul some of the basic principles under which manufacturers have been working under the current MDD.
Implementing the MDR requires a structured approach, since the transition to new MDR CE certificates can last several years.
Watch the presentation here: https://www.greenlight.guru/webinar/eu-mdr-compliance-program-implementation
Software as a Medical Device (SaMD) Challenges and Opportunities for 2021 and...Greenlight Guru
The SARS-CoV-2 pandemic drastically changes the landscape of digital health innovation. The FDA authorized emergency use for a variety of SaMD products including but not limited to mental health, clinical decision support and remote monitoring software applications. In addition, FDA recently launched the Digital Health Center of Excellence, provided updates on the pre-certification program, and host a session to convey FDA’s current thinking on AI/ML SaMD validation.
SaMD manufacturers must keep up with the fast-evolving regulatory landscape and optimize their software development practices with a goal to demonstrate conformance to the QMS requirements effectively and efficiently.
This presentation originally aired during the 2021 State of Medical Device Virtual Summit.
Webinar: Europe's new Medical Device Regulations (MDR)EMERGO
WATCH the recorded webinar here: http://www.emergogroup.com/resources/video-webinar-europe-mdr-changes
The first major revision to device regulations since 2007 has been released and the changes are significant. Although the MDR won't take effect until early 2020, smart companies are planning ahead to beat the crush of companies that will inevitably wait until the last minute, overwhelming EU Notified Bodies. Ronald Boumans, Senior Global Regulatory Consultant for EMERGO (and former IGZ compliance inspector in The Netherlands) outlines the most important changes you need to know in this 35 minute recorded webinar from September 2016. Topics addressed include:
How the MDR is organized
Scope of the legislation
Device classification rules
New clinical evaluation requirements
UDI and EUDAMED database
Adverse event reporting
And much more...
Topics covered include:
• What is RFID?
• Item identification - Barcode or RFID?
• ecom RFID portfolio
• How and where can I use RFID?
• What are the advantages and benefi ts of RFID?
12 Steps for Medical Device UDI Submissions to the FDA GUDIDJoe Hage
UDI regulations kick in for Implantables and Class II devices in 2015.
Reed Tech subject matter expert Gary Saner is my go-to on this subject. He covered:
• Requirements of a GUDID submission system
• Process steps in selecting/launching a GUDID system and making submissions
• Data Fields – including those that are problematic
• Data Cleaning, Harmonization, and Validation tips
• Update on FDA’s changing GUDID guidance, e.g., convenience kits and implants
• Notes in setting up a FDA GUDID account
RELEVANT FOR:
• UDI Team Leaders/Members
• Regulatory Directors/Managers/Staff
• Manufacturing, Operations, and Supply Chain Logistics Personnel
• UDI IT Support Personnel
• Compliance Officers
• Distributors with UDI Submission Responsibilities
Video at http://medgroup.biz/UDI-in-2015
Unique Device Identification: Manufacturer, Hospital and Global ImplicationsApril Bright
Unique device identification (UDI) is gaining global adoption. Now is the time for companies to take a step back and ask: Is my UDI framework scaleable? UDI experts answered questions on the U.S. regulation and provided perspective on ways that device manufacturers can implement a working system—including data management—that can scale with product development and UDI compliance needs. Attendees gained an understanding of new global regulations and practical, implementable advice for compliance.
Global unique device identification database (gudid) and udiJoe Hage
Medical device companies are affected by the Unique Device Identification ruling from FDA. UDI experts Reed Tech help members of the Medical Devices Group understand the complexities.
You can find the audio replay and transcript at http://medgroup.biz/unique-device-identification
Changes in the pipeline for the traceability of medical devices and equipment. Unique Device Identification, Global Medical Device Nomenclature, barcodes and more!
Implementing a Global Unique Device Identification (UDI) Solution: Regional U...Greenlight Guru
UDI data requirement experts Gary Saner and John Lorenc of Reed Tech will discuss best practices for UDI preparations and the future potential impacts to medical device manufacturers as global health authorities publish mandates.
This session will give suggested best practices concerning EU EUDAMED preparation, what we have learned via testing and a Q&A session. Bring your specific questions concerning medical device registration scenarios, data elements and requirements. The speakers will review and provide clarity on currently posted guidance and answer your questions concerning EUDAMED and other health authority timelines.
This presentation originally aired during the 2021 State of Medical Device Virtual Summit.
Prioritizing Documentation for MDR Transition PlanningGreenlight Guru
This session will discuss the one year delay of the MDR date of application as well as some strategies to employ during the MDR Transition. In addition, some approaches for determining documents to prioritize for the transition will be discussed.
This session took place live at the Greenlight Guru True Quality Virtual Summit, a three-day event for medical device professionals to learn to get their devices to market faster, stay ahead of regulatory changes, and use quality as their multiplier to grow their device business.
This short presentation is giving a brief introduction of the general status of china medial device industry, as well as an explanation about the CFDA and the medical registration process in china
Unique Device Identification or UDI is a forever project. What's the best way for orthopaedic device companies to receive return on their investment? What best practices can be learned for a continually-smooth process? How can the data be leveraged to enhance your company’s value proposition? The true value of UDI is not in the identification number, but in the data that can be generated as a result of UDI. This session will provide attendees with an outline of the opportunities that manufacturers can leverage beyond implementation.
On September 24, 2013, the U.S. Food and Drug Administration announced the new requirement to identify medical devices that affect its safe and effective use through the use of UDI. Explore on how Freyr can help medical device companies achieve UDI compliance.
How User Experience Design and Human Factors Engineering can Accelerate Produ...Greenlight Guru
A growing number of medtech companies are embracing User Experience (UX) Design and Human Factors Engineering (HFE) — not just to meet FDA regulations, but also to create more intuitive, more usable, and holistically better products. These practices required to promote safety and efficacy also provide an opportunity for your company to quickly deliver products that are more innovative, which can be a key differentiator in the competitive medical device market.
This session will answer the questions: what is Human Factors Engineering and why is it important? We’ll also cover:
• Human Factors guidance and regulations
• Human Factors Engineering process overview
• Differences between regulatory usability and UX
• How to use UX to feed regulatory development
This session took place live at the Greenlight Guru True Quality Virtual Summit, a three-day event for medical device professionals to learn to get their devices to market faster, stay ahead of regulatory changes, and use quality as their multiplier to grow their device business.
8 Steps You Should Be Taking to Implement an EU-MDR Compliance ProgramGreenlight Guru
The new MDR will affect all Medical Device manufacturers.
The availability of the text for the new European Medical Device Regulation allows manufacturers to start the process of assessing the impact it will have on their activities, and what they will need to do to be compliant with the revised requirements.
The MDR will overhaul some of the basic principles under which manufacturers have been working under the current MDD.
Implementing the MDR requires a structured approach, since the transition to new MDR CE certificates can last several years.
Watch the presentation here: https://www.greenlight.guru/webinar/eu-mdr-compliance-program-implementation
Software as a Medical Device (SaMD) Challenges and Opportunities for 2021 and...Greenlight Guru
The SARS-CoV-2 pandemic drastically changes the landscape of digital health innovation. The FDA authorized emergency use for a variety of SaMD products including but not limited to mental health, clinical decision support and remote monitoring software applications. In addition, FDA recently launched the Digital Health Center of Excellence, provided updates on the pre-certification program, and host a session to convey FDA’s current thinking on AI/ML SaMD validation.
SaMD manufacturers must keep up with the fast-evolving regulatory landscape and optimize their software development practices with a goal to demonstrate conformance to the QMS requirements effectively and efficiently.
This presentation originally aired during the 2021 State of Medical Device Virtual Summit.
Webinar: Europe's new Medical Device Regulations (MDR)EMERGO
WATCH the recorded webinar here: http://www.emergogroup.com/resources/video-webinar-europe-mdr-changes
The first major revision to device regulations since 2007 has been released and the changes are significant. Although the MDR won't take effect until early 2020, smart companies are planning ahead to beat the crush of companies that will inevitably wait until the last minute, overwhelming EU Notified Bodies. Ronald Boumans, Senior Global Regulatory Consultant for EMERGO (and former IGZ compliance inspector in The Netherlands) outlines the most important changes you need to know in this 35 minute recorded webinar from September 2016. Topics addressed include:
How the MDR is organized
Scope of the legislation
Device classification rules
New clinical evaluation requirements
UDI and EUDAMED database
Adverse event reporting
And much more...
Topics covered include:
• What is RFID?
• Item identification - Barcode or RFID?
• ecom RFID portfolio
• How and where can I use RFID?
• What are the advantages and benefi ts of RFID?
IJRET : International Journal of Research in Engineering and Technology is an international peer reviewed, online journal published by eSAT Publishing House for the enhancement of research in various disciplines of Engineering and Technology. The aim and scope of the journal is to provide an academic medium and an important reference for the advancement and dissemination of research results that support high-level learning, teaching and research in the fields of Engineering and Technology. We bring together Scientists, Academician, Field Engineers, Scholars and Students of related fields of Engineering and Technology
In fast-paced mass manufacturing, every product needs to be identified for traceability to avoid the slipping of faulty products into the hands of consumers.
RFID in PV Solar Manufacturing Industryiaitoinfotech
Government of India had come out with the new mandate guideline under JNNSM that each of the PV modules used under this mission should be attached with the RFID tags to keep its accountability,authenticity & performance measurement.RFID allows better monitoring of the PV manufacturing processes with expedient raw material flow and more effective planning and control.
RFID Based Security and Access Control System using ARDUINOIJMTST Journal
There has been rising demand for secure system that must be dependable and quick respond for the industries and company. To secure industries and companies this concept is helpful. RFID (Radio Frequency Identification) is one of the consistent and fast means of identify the material object. In the long ago the barcode’s are more preferable as compared to RFID because of their cost but now a day’s RFID are easily available and are more convenient to use. Research has made some drastic changes which makes its programming a lot shorter and easier is because of replacing microcontroller with Arduino. Arduino makes the circuit and programming a lot easier to understand. This project is based upon security access and control system using RFID and Arduino. Security access system is very convenient to use at home, office and commercial buildings
Introduction to RFID Solutions in Canada44 Deg North
RFID is transforming industries across Canada, offering enhanced inventory management, asset tracking, and operational efficiency. This presentation will explore the RFID market in Canada, top solution providers, and the benefits of implementing this cutting-edge technology.
Introduction to RFID Solutions in Canada44 Deg North
RFID is transforming industries across Canada, offering enhanced inventory management, asset tracking, and operational efficiency. This presentation will explore the RFID market in Canada, top solution providers, and the benefits of implementing this cutting-edge technology.
Barcode & RFID Convergence: Enabling Greater Visibility Through StandardsVDC Research Group
This webcast was presented by VDC Research on the convergence of Barcode and RFID technologies on the GS1 US Visibility Framework.
Barcode is the dominant track and trace technology on the planet today and its value proposition is being extended by the more automated features of RFID. While these two technologies are often viewed as competitive, they are actually complimentary, and organizations are realizing the best of both worlds when they use GS1 standards as the framework for integrating RFID to improve their business processes.
Members of GS1 US and/or EPCglobal US will see that they not only have the foundation for enhanced visibility solutions, but they can implement them in a more cost effective and timely manner - all while realizing the benefits of building those solutions on a common architecture.
Smart Labels - Digital Innovation by Raw Material Suppliers to Support Drug M...MilliporeSigma
This webinar will highlight different barcode types, regulations and standards applied to 2D barcodes in the industry, as well as applications and advantages of 2D Data Matrix barcodes.
Digital technologies offer new opportunities to provide and exchange information between raw material suppliers and their customers. While accessing product-related data for different raw materials and devices is essential, it can be a cumbersome task in the pharmaceutical quality and production processes. Often, data processing is required at many steps and must be done manually, which is time consuming and a source for potential errors. 2D Data Matrix barcodes offer a seamless and robust solution for data management, internal processes and inventory management challenges.
In this webinar, you will learn:
• Overview of different barcode types
• Regulations and standards applied to 2D barcodes in the industry
• Applications and advantages of 2D Data Matrix barcodes
Smart Labels - Digital Innovation by Raw Material Suppliers to Support Drug M...Merck Life Sciences
This webinar will highlight different barcode types, regulations and standards applied to 2D barcodes in the industry, as well as applications and advantages of 2D Data Matrix barcodes.
Digital technologies offer new opportunities to provide and exchange information between raw material suppliers and their customers. While accessing product-related data for different raw materials and devices is essential, it can be a cumbersome task in the pharmaceutical quality and production processes. Often, data processing is required at many steps and must be done manually, which is time consuming and a source for potential errors. 2D Data Matrix barcodes offer a seamless and robust solution for data management, internal processes and inventory management challenges.
In this webinar, you will learn:
• Overview of different barcode types
• Regulations and standards applied to 2D barcodes in the industry
• Applications and advantages of 2D Data Matrix barcodes
Trauma Outpatient Center is a comprehensive facility dedicated to addressing mental health challenges and providing medication-assisted treatment. We offer a diverse range of services aimed at assisting individuals in overcoming addiction, mental health disorders, and related obstacles. Our team consists of seasoned professionals who are both experienced and compassionate, committed to delivering the highest standard of care to our clients. By utilizing evidence-based treatment methods, we strive to help our clients achieve their goals and lead healthier, more fulfilling lives.
Our mission is to provide a safe and supportive environment where our clients can receive the highest quality of care. We are dedicated to assisting our clients in reaching their objectives and improving their overall well-being. We prioritize our clients' needs and individualize treatment plans to ensure they receive tailored care. Our approach is rooted in evidence-based practices proven effective in treating addiction and mental health disorders.
TOP AND BEST GLUTE BUILDER A 606 | Fitking FitnessFitking Fitness
"Feature:
• Intelligent Ergonomically Design Glute Builder Is A Must Have For Those Looking To Target Their Gluteal Muscles And Hamstrings With Precision.
• The Ability To Adjust The Starting Position, This Machine Allows For A More Targeted Workout That Is Tailored To Your Specific Needs.
• Spacious And Supportive Cushioned Seat Provide Added Comfort And Stability During Your Workout."
Get more information visit on:- www.fitking.in
Our mail I.D:-care@fitking.in, fitking.in@gmail.com
Call us at :- 9958880790, 9870336406, 8800695917
Deep Leg Vein Thrombosis (DVT): Meaning, Causes, Symptoms, Treatment, and Mor...The Lifesciences Magazine
Deep Leg Vein Thrombosis occurs when a blood clot forms in one or more of the deep veins in the legs. These clots can impede blood flow, leading to severe complications.
PET CT beginners Guide covers some of the underrepresented topics in PET CTMiadAlsulami
This lecture briefly covers some of the underrepresented topics in Molecular imaging with cases , such as:
- Primary pleural tumors and pleural metastases.
- Distinguishing between MPM and Talc Pleurodesis.
- Urological tumors.
- The role of FDG PET in NET.
Health Education on prevention of hypertensionRadhika kulvi
Hypertension is a chronic condition of concern due to its role in the causation of coronary heart diseases. Hypertension is a worldwide epidemic and important risk factor for coronary artery disease, stroke and renal diseases. Blood pressure is the force exerted by the blood against the walls of the blood vessels and is sufficient to maintain tissue perfusion during activity and rest. Hypertension is sustained elevation of BP. In adults, HTN exists when systolic blood pressure is equal to or greater than 140mmHg or diastolic BP is equal to or greater than 90mmHg. The
COVID-19 PCR tests remain a critical component of safe and responsible travel in 2024. They ensure compliance with international travel regulations, help detect and control the spread of new variants, protect vulnerable populations, and provide peace of mind. As we continue to navigate the complexities of global travel during the pandemic, PCR testing stands as a key measure to keep everyone safe and healthy. Whether you are planning a business trip, a family vacation, or an international adventure, incorporating PCR testing into your travel plans is a prudent and necessary step. Visit us at https://www.globaltravelclinics.com/
Empowering ACOs: Leveraging Quality Management Tools for MIPS and BeyondHealth Catalyst
Join us as we delve into the crucial realm of quality reporting for MSSP (Medicare Shared Savings Program) Accountable Care Organizations (ACOs).
In this session, we will explore how a robust quality management solution can empower your organization to meet regulatory requirements and improve processes for MIPS reporting and internal quality programs. Learn how our MeasureAble application enables compliance and fosters continuous improvement.
ICH Guidelines for Pharmacovigilance.pdfNEHA GUPTA
The "ICH Guidelines for Pharmacovigilance" PDF provides a comprehensive overview of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines related to pharmacovigilance. These guidelines aim to ensure that drugs are safe and effective for patients by monitoring and assessing adverse effects, ensuring proper reporting systems, and improving risk management practices. The document is essential for professionals in the pharmaceutical industry, regulatory authorities, and healthcare providers, offering detailed procedures and standards for pharmacovigilance activities to enhance drug safety and protect public health.
The Importance of Community Nursing Care.pdfAD Healthcare
NDIS and Community 24/7 Nursing Care is a specific type of support that may be provided under the NDIS for individuals with complex medical needs who require ongoing nursing care in a community setting, such as their home or a supported accommodation facility.
FREYR UDI VISION SERIES SESSION 2 - BARCODING & LABELING
1. 1 CONSULTING | TECHNOLOGY | OPERATIONS | AFFAIRS | OUTSOURCING
www.freyrinc.com CONSULTING | TECHNOLOGY | OPERATIONS | AFFAIRS | OUTSOURCING
WELCOME TO
FREYR UDI VISION SERIES
The webinar will begin shortly!
2. 2 CONSULTING | TECHNOLOGY | OPERATIONS | AFFAIRS | OUTSOURCING
www.freyrinc.com CONSULTING | TECHNOLOGY | OPERATIONS | AFFAIRS | OUTSOURCING
FREYR UDI VISION SERIES
PART 2 – Labeling and Barcoding
Date: 21 Nov 2014
3. 3 CONSULTING | TECHNOLOGY | OPERATIONS | AFFAIRS | OUTSOURCING
Session 2 - Agenda
1. Freyr Fact Sheet
2. UDI Labeling & Barcode Standards
3. RFID in Medical Devices
4. UDI Labeling for Different Device Types
5. Exemptions and Highlights
6. Q&A SESSION 1 – AGENDA
1. Overview - UDI
2. GUDID Components
3. UDI – Master Data Management
4. Freyr Leverage – UDI Expertise
5. Freyr IDENTITY – UDI Software Solution
6. Freyr Corporate OverviewDISCLAIMER: All images, pictures showcased are property of their respective legal owners
(GS1, HIBCC & ICCBBA) and are used for illustrative/ information purposes only.
4. 4 CONSULTING | TECHNOLOGY | OPERATIONS | AFFAIRS | OUTSOURCING
→ Headquartered in New Jersey, USA with
Regulatory Operations & Data Centre in
Cranbury, NJ, USA
→ Global Regulatory Operations & Development
Centre in Hyderabad, India, Asia’s leading Bio-
Tech Hub with an office in Maidenhead, UK
→ Robust Information Security and Quality ISO
9001 & ISO 27001 Certified Processes with
state-of-the-art infrastructure and BCP & DR
site
→ Best-in-class Regulatory Consulting, Technology
and high-value/ low-cost Outsourcing Services
→ Rapidly growing strong 350+ team of
regulatory, scientific, technology & consulting
professionals
→ Freyr is the preferred partner to Top 10 Fortune
50 Bio-Pharma & Consumer Healthcare and
several Small-Medium Pharma & Life Sciences
Companies.
Freyr, is a fast-growing, Global Regulatory Solutions & Services company with an exclusive focus on the entire
Regulatory value-chain
Freyr Consulting and
Advisory Services
1. Freyr IDENTITY – Stand alone Software for UDI
2. Freyr ACCELERATE - Building custom validated
Enterprise scale applications coupled with Freyr
Identity solution (Custom Bolt-on Solutions)
3. Operational Data Management
UDI READINESS
ASSESSMENT/
GAP ANALYSIS
DI IMPLEMENTATION
& SUBMISSION
MANAGEMENT
LIFE CYCLE
MANAGEMENT
Freyr in the UDI Space
Freyr Fact Sheet
6. 6 CONSULTING | TECHNOLOGY | OPERATIONS | AFFAIRS | OUTSOURCING
UDI Representation:
According to UDI final rule, the UDI must appear on every device as device label or direct marking.
It is presented in two forms:
(1) Easily readable plain-text or Human Readable Interpretation (HRI), and
(2) Automatic identification and data capture (AIDC) technology.
Direct Marking (DM):
A device that must bear a unique device identifier (UDI) on its label must also bear a permanent marking providing
the UDI on the device itself if the device is intended to be used more than once and intended to be reprocessed
before each use.
The UDI provided through a direct marking on a device may be:
(1) Identical to the UDI that appears on the label of the device, or
(2) A different UDI used to distinguish the unpackaged device from any device package containing the device.
Date Format:
The format is: the year, using four digits: followed by the month, using two digits; followed by the day, using two
digits; each separated by hyphens. For example, January 2, 2014, must be presented as 2014-01-02.
UDI Compliant Labeling
7. 7 CONSULTING | TECHNOLOGY | OPERATIONS | AFFAIRS | OUTSOURCING
CHALLENGES MITIGATION
• Selection of IA based on
the device type and their
applicability
• Profile the devices and
based on their portfolio
apply to respective IA
• Every device label
marketed by the labeler
needs to be reworked
• Based on the selected IA
the artwork team needs to
redesign the labels
• Inventories of preprinted
stationery of labels
• Plan earlier to avoid
wastage of labels
• Impact of DM (Direct
Marking) on applicable
devices
• DM applicability for
devices needs to be
identified and the
production line must be
equipped with
infrastructure to support
DM requirements. The
production staff must be
trained on the new
infrastructure
Format of the numbering and the standard for AIDC is
mandated by the Issuing Agency (IA).
Every IA has a different set of numbering and AIDC
standards
Industry Challenges
Based on the IA selection, the labeler has to rework the
label format through their artwork and publishing team
to accommodate the UDI in both HRI and AIDC formats
This exercise needs to be done for each and every device
that is marketed by the labeller
This again implies the need to start the UDI compliancy
activity at the earliest
8. 8 CONSULTING | TECHNOLOGY | OPERATIONS | AFFAIRS | OUTSOURCING
GS1 Labeling Standards
GUDID DataDate Lot
PI
DI
LINEAR SYMBOLOGY
15416:2000 – AIDC techniques -- Bar code print quality test
specification -- Linear symbols
15417:2007 – AIDC - Code 128 bar code symbology specification
15423:2009 – AIDC techniques -- Bar code scanner and decoder
performance testing
15426-1:2006 – AIDC techniques -- Bar code verifier conformance
specification -- Part 1: Linear symbols
15426-2:2005 – AIDC techniques -- Bar code verifier conformance
specification -- Part 2: Two-dimensional symbols
2D SYMBOLOGY
15415:2011 – AIDC - Bar code symbol print quality test specification -
Two-dimensional symbols
16022:2006 – AIDC techniques - Data Matrix bar code symbology
specification
Under GS1, the Global Trade Item Number™ (GTIN™)
is used for the unique identification of trade items worldwide.
9. 9 CONSULTING | TECHNOLOGY | OPERATIONS | AFFAIRS | OUTSOURCING
GS1 – Barcoding Standards
1 2 3 4
Device Identifier
Expiration Date2
1
Lot number
Serial number4
3
AIDC format: Example using GS1-128:
AIDC format: Example using GS1-Datamatrix:
2
4
3
1
10. 10 CONSULTING | TECHNOLOGY | OPERATIONS | AFFAIRS | OUTSOURCING
HIBCC Labeling Standards
DI
PI
GUDID
Data
GUDID
Data
LINEAR SYMBOLOGY
15416:2000 – AIDC techniques -- Bar code print
quality test specification -- Linear symbols
15417:2007 – AIDC - Code 128 bar code symbology
specification
16388 – AIDC – techniques – Code 39 bar code
symbology specification
2D SYMBOLOGY
15415:2011 – AIDC - Bar code symbol print quality test
specification - Two-dimensional symbols
16022:2006 – AIDC techniques - Data Matrix bar code
symbology specification
18004:2006 – AIDC – techniques - QR Code bar code
symbology specification
24728 – AIDC techniques – MicroPDF417 bar code
symbology specification
24778 – AIDC techniques -- MicroPDF417 bar code
symbology specification
Labeler identification Code (LIC) is assigned by HIBCC and it Identifies the
labeler.
11. 11 CONSULTING | TECHNOLOGY | OPERATIONS | AFFAIRS | OUTSOURCING
HIBCC - Barcoding Standards
Primary and Secondary Data in a 2D Symbol
HIBC LIC Secondary Code Data Structure
+A99912345 / $$59901510X3J
53 22 98761 4
+A99912345 / $$59901510X3J
53 22 98761 4
HIBC Supplier Labeling flag
LIC2
1
Product ID3
5
4
6
7
8
Unit of Measure
Data delimiter
Exp. Date Flag
Expiration Date
Lot Number
9 Check Character
12. 12 CONSULTING | TECHNOLOGY | OPERATIONS | AFFAIRS | OUTSOURCING
ICCBBA Labeling Standards
GUDID
Data
GUDID
Data
LINEAR SYMBOLOGY
15416:2000 – AIDC techniques -- Bar code print quality
test specification -- Linear symbols
15417:2007 – AIDC - Code 128 bar code symbology
specification
2D SYMBOLOGY
15415:2011 – AIDC - Bar code symbol print quality test
specification - Two-dimensional symbols
16022:2006 – AIDC techniques - Data Matrix bar code
symbology specification
ISBT 128 is the global standard for the terminology, identification, labeling, and information transfer of medical products of
human origin (including blood, cell, tissue, and organ products) across international borders and disparate health care systems.
13. 13 CONSULTING | TECHNOLOGY | OPERATIONS | AFFAIRS | OUTSOURCING
ICCBBA - Barcoding Standards
Issuing
Agency
Data
Delimiters Identifier Data type
Human Readable Barcode
Field Size
Database
Field Size
ICCBBA =/ DI Alphanumeric 18 16
ICCBBA =, Serial Number Alphanumeric 8 6
ICCBBA = Donation Identification Number Alphanumeric 16 15
ICCBBA => Expiration Date numeric [YYYJJJ] 8 6
ICCBBA =} Manufacturing Date numeric [YYYJJJ] 8 6
ICCBBA &,1 MPHO Lot Number Alphanumeric 21 18
Ex of Human Readable Barcode:=/A9999XYZ100T0944=,000025=A99971312345600=>014032=}013032&,1000000000000XYZ123
ISBT 128-Linear Barcode
2 53 41
Facility identification code
Year of collection-donation
3
1
Serial number
2
5
4 Flag character-turned 90⁰
Check digit
14. 14 CONSULTING | TECHNOLOGY | OPERATIONS | AFFAIRS | OUTSOURCING
RFID in Medical Devices
Presenter : Alan
15. 15 CONSULTING | TECHNOLOGY | OPERATIONS | AFFAIRS | OUTSOURCING
Radio Frequency Identification (RFID)
RFID has the potential in healthcare to achieve improvements in both supply chain productivity and patient
safety applications.
The ISO approach to RFID implementation is based upon healthcare product supplier migration from existing
barcode or 2-D symbologies to RFID.
Barcoding will continue to be used in the future, and will co-exist with RFID. As with all technologies, each will
be utilized in the functions for which it offers the highest benefit/cost ratio and comparative advantage.
RFID utilizes data chips that do not have to be visible to be scanned. RFID tags are unique serial numbers that
allow tracking of the lowest unit of measure that is tagged.
The volume of data contained within RFID tags is dependent on size and type, containing up to 128 kilobytes
of data.
An RFID tag can be one-time use or re-useable. RFIDs are the most expensive of the barcode options.
RFID technology enables manufacturers of reprocessed or reusable medical devices to comply with the direct
part marking requirement of the FDA Final Rule for UDI.
ISO/IEC 15418 (Incorporating ANS MH10.8.2 Data Identifiers), and ISO/IEC 15961, 15962 and 15963 are
normative references for UDI RFID data protocols.
16. 16 CONSULTING | TECHNOLOGY | OPERATIONS | AFFAIRS | OUTSOURCING
RFID Visibility to UDI Inventory
Device
Manufacturer
3 PL or DC
Hospital
or Medical
Facility
RFID Event
LEAVE_MANUFACTURER
RFID Event
ARRIVE_DISTRIBUTION
UDI ‘SmartLabels’
on Packaging Known ‘PI’ Inventory at
Customers location
RFID Event
Management
Software
EventData
RFID Event
ARRIVE_CUSTOMER
UDI RFID Deployment
in Supply Chain
Track &
Trace
Customer Enterprise
17. 17 CONSULTING | TECHNOLOGY | OPERATIONS | AFFAIRS | OUTSOURCING
Presenter : Prasanna
UDI Labeling for Different Device Types
18. 18 CONSULTING | TECHNOLOGY | OPERATIONS | AFFAIRS | OUTSOURCING
Single Use Devices
Single-use devices (SUDs) come under an exception of not having an UDI, provided that:
• The UDI appears on the device package
• All SUDs of a single version/model are distributed together in a single device package
• They are to be stored in that device package until removed for use
• They are not meant for individual commercial distribution
• Implants that fall under SUDs do not have this exception
If the devices are intended for individual commercial distribution, the device label and
package for these individual devices is required to bear a UDI
Single-use devices that are implants which are subjected to additional processing and
manufacturing are exempted from having a permanent UDI on the device
19. 19 CONSULTING | TECHNOLOGY | OPERATIONS | AFFAIRS | OUTSOURCING
Combination Products / Kits
Combination products are required to have an UDI, however the device constituent part of that
combination product or kit are exempt from the UDI requirement. Combination products include;
Convenience Kits, in-vitro diagnostic kits, and HCT/Ps, etc.
Each component, sub-system or accessory that is considered a medical device and is commercially
available needs a separate UDI unless the components are part of a convenience, medical
procedure, IVD kit or configurable medical device system that is marked with its own UDI.
If the combination product instead has an NDC code, it is exempt from the UDI requirements
however in that case, the device constituent part must have the UDI unless the product is a single
entity combination product where the drug/device are physically, chemically or otherwise
combined.
20. 20 CONSULTING | TECHNOLOGY | OPERATIONS | AFFAIRS | OUTSOURCING
Stand-Alone Software
The UDI Rule does not provide any special requirements for a device that contains software as a
component of the device, but does require stand-alone medical software to be labeled with a UDI.
All stand-alone software, whether packaged or unpackaged (e .g., software downloaded from a
website), must provide its UDI through either or both of the following:
• An easily readable plain-text statement displayed whenever the software is started
• An easily readable plain-text statement displayed through a menu command (e.g., an
“About...” menu command)
Stand-alone software that is distributed in packaged form is subject to the same UDI labeling
requirements as any other medical device -- the device label and device package must bear a UDI in
plain-text and AIDC formats.
Stand-alone software that is distributed in both packaged and unpackaged form may be identified
with the same DI. Stand-alone software that is not distributed in packaged form must convey the
version number in its production identifier.
21. 21 CONSULTING | TECHNOLOGY | OPERATIONS | AFFAIRS | OUTSOURCING
Exemptions and Highlights
Presenter : Alan
22. 22 CONSULTING | TECHNOLOGY | OPERATIONS | AFFAIRS | OUTSOURCING
General Exemptions
Single Use Device Exception (multiple in 1 Package, any class/except implants): UDI required on device package,
not required on device label.
Class III Extension +1 year, if request is approved.
GMP exempt Class I devices are exempt completely from the UDI requirements; however, the standardized date format
requirement still applies.
Single-use contact lenses are subject to the exemption from the need to be individually labeled with a UDI under
§ 801.30(a)(3).
Boxes or containers used explicitly for shipping and transportation are exempted from UDI requirements
Direct marking is now only required for devices that are reusable i.e. device intended to be reprocessed before each use.
There are provisions for exemptions from direct marking if the marking would affect the device safety or effectiveness or if
it is technologically not feasible.
Device constituents which are part of the combination product or kit and not commercially available are exempt from the
UDI requirement.
A Medical device used solely for research, teaching, or chemical analysis, and not intended for any clinical use.
Veterinary medical device need not to have a UDI.
PI attribute information is optional for Class-I devices
23. 23 CONSULTING | TECHNOLOGY | OPERATIONS | AFFAIRS | OUTSOURCING
Medical Device in Inventory
UDI requirements apply to devices placed into commercial distribution after the compliance date that
applies to the device.
A finished device manufactured and labeled prior to its compliance date and held in inventory is
excepted from UDI requirements for three years after the compliance date.
This exception applies to both products held in inventory by the labeler and those consigned to a
hospital or other potential purchaser and held in inventory, but not yet purchased, by the potential
purchaser.
This exception applies to all UDI requirements.
24. 24 CONSULTING | TECHNOLOGY | OPERATIONS | AFFAIRS | OUTSOURCING
Implantable Devices
The UDI Rule does not require an implantable device to be directly marked with its UDI.
CDRH believes that the UDI label and package requirements will provide for adequate identification of an
implantable device up to the point where it is implanted.
CDRH also acknowledges the common practice of recording information about implanted devices both in the
patient's health record (EHRs and PHRs), and on a card provided to the patient, and they expect health care
providers will incorporate UDIs into both of these types of records.
UDI – Small Labels
The final rule does not specify the type of label that is required to bear a UDI. It is up to the labeler to determine an
appropriate method to apply the UDI to the device label. An add-on label, in some instances, may be appropriate.
However, a UDI must be included on the device label and every device package.
Device labels not able to accommodate both AIDC and HRI should “Request for an Exception from or Alternative to a
Unique Device Identifier Requirement—Proposed § 801-35; § 801.55 of the Final Rule.”
25. 25 CONSULTING | TECHNOLOGY | OPERATIONS | AFFAIRS | OUTSOURCING
www.freyrinc.com CONSULTING | TECHNOLOGY | OPERATIONS | AFFAIRS | OUTSOURCING
Questions?
Please Post
Questions
in the
Questions
Panel
26. 26 CONSULTING | TECHNOLOGY | OPERATIONS | AFFAIRS | OUTSOURCING
www.freyrinc.com CONSULTING | TECHNOLOGY | OPERATIONS | AFFAIRS | OUTSOURCING
US Headquarters
1 Bell Street, Maidenhead,
Berkshire, SL6 1BU
Phone +44 1133 508632
103 Carnegie Centre, Suite
300, Princeton, NJ – 08540
1 Farr View Dr, STE 5E ,
Cranbury Township, NJ
08512
Phone +1 908 345 5984
UK
North America
Operations Center
Lanco Hills Technology
Park, Manikonda,
Hyderabad, India
Phone +91 40 4848 0999
India Global
Operations Center
contactus@freyrsolutions.com
Thank You!