The document outlines the key steps in the medical device design and development process as required by ISO 13485. This includes establishing procedures for design and development stages, planning with target dates and reviews, determining inputs, producing outputs like drawings and bills of materials, conducting reviews and verification to ensure outputs meet inputs, performing validation to ensure the product meets requirements, and controlling any changes to the design.
This presentation consist of what ISO 14971 is and why is it important to consider this standard while designing a medical device or any device for that matter. It will help u understand what Risk actual is and importance of risk management in medical device industry. It gives you insight about Risk management technique. You will Understand FMEA and how to use it.
Medical Device testing ensures the product’s software and devices are fully compatible and compliant with various regulations and functionality. This testing ensures that these devices fulfill all quality-related aspects successfully for which QA plays an important role.
This presentation consist of what ISO 14971 is and why is it important to consider this standard while designing a medical device or any device for that matter. It will help u understand what Risk actual is and importance of risk management in medical device industry. It gives you insight about Risk management technique. You will Understand FMEA and how to use it.
Medical Device testing ensures the product’s software and devices are fully compatible and compliant with various regulations and functionality. This testing ensures that these devices fulfill all quality-related aspects successfully for which QA plays an important role.
What do hospital beds, blood pressure cuffs, dosimeters, and pacemakers all have in common? They are all medical devices with software that regulates their functionality in a way that contributes to Basic Safety or Essential Performance. With the FDA reporting that the rate of medical device recalls between 2002 and 2012 increased by 100% – where software design failures are the most common reason for the recalls – it’s no wonder IEC 62304 has been implemented. Its implementation, however, has medical device manufacturers asking questions about if, when and under what circumstances the standard is required.
This article explains what IEC 62304 is, when medical devices must comply with it and how IEC 62304 compliance is assessed.
Risk Management for Medical Devices - ISO 14971 Overview Greenlight Guru
Risk Management for Medical Devices. An overview of ISO 14971 & how to apply a "Risk-based Approach" to your QMS processes to address the upcoming changes to ISO 13485.
Risk management in the development of medical devices. This presentation was for a webinar where we discussed the basics of risk management, a general risk management lifecycle, the requirements of certain relevant standards (ISO 14971, IEC 62304, US FDA Title 21 CFR Part 11), and the practical method called HFMEA. The live demonstration shows you how risks can be managed and compliance achieved using the advanced risk management features of codeBeamer ALM, and also demonstrates the use of our (general) FMEA template.
A brief introduction on medical device , how iit is regulated in india,its marketing authorization,classification, notified devices,import of device and registration process, fnctions of medical device department.
To comprehend the regulatory requirements to import medical Medical devices and authorization procedures in regulated markets of the United States and Australia
How to Prepare for the New EU Medical Device Regulations (MDR)Greenlight Guru
The new MDR is expected to be formally published in late 2016 or early 2017, and there will be a three-year transition period to be compliant.
Many forward thinking medical device companies are already developing their plans for compliance now to gain strategic advantages over their competitors.
In this presentation you will learn:
-Why the European regulations are changing
-An overview of the text being voted on
-What does the new regulation mean for manufactures
-Examine the risk based approach to classification
-Strategy for technical documentation preparation
-Changes to clinical evidence for devices
-Post market surveillance and vigilance for medical devices
-What you can do to start preparing now
-What are all the significant changes
You can watch the recording of this presentation here: https://www.greenlight.guru/webinar/eu-medical-device-regulations-mdr
Medical devices – Quality management
systems – Requirements for regulatory
Purposes. ISO is an organization that develops Standards for use
worldwide.
ISO 13485 helps companies do their share in protecting
consumers and users of medical devices.
ISO 13485 Outlines criteria for a good Quality
Management System (QMS).
QMS criteria are good business practices ...
for example:
• Set Quality goals
• Ensure that regulations and other requirements are
understood and met
• Train employees
• Control your production processes
• Purchase from suppliers that can provide products that
meet your requirements
• Correct problems and make sure they do not happen again
Common Mistakes in the Medical Device Development ContinuumNAMSA
Getting a medical device to market is a long process made up of multiple stages. Each stage requires a number of elements that need to be considered before progress can be made with the device. And even after market approval has been obtained, there is a continuous need to reevaluate and test the device to maintain safety and efficacy.
Throughout this development process, several steps can be missed that may result in submission refusal, or possibly a faulty device.
Medtech start-ups from inception to exit: what are the key milestones and what are the ACTUAL timelines and costs?
A data-driven approach to figuring out the new reality of medical device venture capital investing.
What do hospital beds, blood pressure cuffs, dosimeters, and pacemakers all have in common? They are all medical devices with software that regulates their functionality in a way that contributes to Basic Safety or Essential Performance. With the FDA reporting that the rate of medical device recalls between 2002 and 2012 increased by 100% – where software design failures are the most common reason for the recalls – it’s no wonder IEC 62304 has been implemented. Its implementation, however, has medical device manufacturers asking questions about if, when and under what circumstances the standard is required.
This article explains what IEC 62304 is, when medical devices must comply with it and how IEC 62304 compliance is assessed.
Risk Management for Medical Devices - ISO 14971 Overview Greenlight Guru
Risk Management for Medical Devices. An overview of ISO 14971 & how to apply a "Risk-based Approach" to your QMS processes to address the upcoming changes to ISO 13485.
Risk management in the development of medical devices. This presentation was for a webinar where we discussed the basics of risk management, a general risk management lifecycle, the requirements of certain relevant standards (ISO 14971, IEC 62304, US FDA Title 21 CFR Part 11), and the practical method called HFMEA. The live demonstration shows you how risks can be managed and compliance achieved using the advanced risk management features of codeBeamer ALM, and also demonstrates the use of our (general) FMEA template.
A brief introduction on medical device , how iit is regulated in india,its marketing authorization,classification, notified devices,import of device and registration process, fnctions of medical device department.
To comprehend the regulatory requirements to import medical Medical devices and authorization procedures in regulated markets of the United States and Australia
How to Prepare for the New EU Medical Device Regulations (MDR)Greenlight Guru
The new MDR is expected to be formally published in late 2016 or early 2017, and there will be a three-year transition period to be compliant.
Many forward thinking medical device companies are already developing their plans for compliance now to gain strategic advantages over their competitors.
In this presentation you will learn:
-Why the European regulations are changing
-An overview of the text being voted on
-What does the new regulation mean for manufactures
-Examine the risk based approach to classification
-Strategy for technical documentation preparation
-Changes to clinical evidence for devices
-Post market surveillance and vigilance for medical devices
-What you can do to start preparing now
-What are all the significant changes
You can watch the recording of this presentation here: https://www.greenlight.guru/webinar/eu-medical-device-regulations-mdr
Medical devices – Quality management
systems – Requirements for regulatory
Purposes. ISO is an organization that develops Standards for use
worldwide.
ISO 13485 helps companies do their share in protecting
consumers and users of medical devices.
ISO 13485 Outlines criteria for a good Quality
Management System (QMS).
QMS criteria are good business practices ...
for example:
• Set Quality goals
• Ensure that regulations and other requirements are
understood and met
• Train employees
• Control your production processes
• Purchase from suppliers that can provide products that
meet your requirements
• Correct problems and make sure they do not happen again
Common Mistakes in the Medical Device Development ContinuumNAMSA
Getting a medical device to market is a long process made up of multiple stages. Each stage requires a number of elements that need to be considered before progress can be made with the device. And even after market approval has been obtained, there is a continuous need to reevaluate and test the device to maintain safety and efficacy.
Throughout this development process, several steps can be missed that may result in submission refusal, or possibly a faulty device.
Medtech start-ups from inception to exit: what are the key milestones and what are the ACTUAL timelines and costs?
A data-driven approach to figuring out the new reality of medical device venture capital investing.
FDA Design Controls: What Medical Device Makers Need to KnowGreenlight Guru
FDA Design Control regulations defined in 21 CFR 820.30 have been in place for 20 years now, yet year after year they continue to be one of the top issues cited during inspections.
This does not, and should not, be the case for your medical device company.
Join us for this free, two-part webinar series presented by two of the world's leading experts on the topic to learn how to implement a design control process that will not only ensure compliance but will actually benefit your product development efforts.
(You can view both webinars here: http://www.greenlight.guru/webinar/medical-device-design-controls)
In Part 1, you'll learn about Intended Use, User Needs, Design Inputs, Design Reviews, Design History File (DHF) and Risk Management.
Specifically:
-The importance of getting your intended use right up front
-The difference between a user need and a design input that's verifiable
-What stakeholders need to be involved in the process and why
-When and how many design reviews you should hold
-Why FMEA alone is NOT risk management and how to integrate risk into the design and development process
In Part 2, you'll learn about Design Outputs, Device Master Record (DMR), Design Verification and Validation (V&V), Design Transfer and Regulatory Submissions.
Specifically:
-Why your design outputs need to be more than a drawing and their relationship to your DMR
-How usability and human factors fits into the overall product development
-Making sure you build the correct device and build it correctly with design V&V
-Common mistakes people make during design transfer to production and how to avoid them
-When you can and should make your regulatory submission
With new technologies come many innovative medical devices and tools to help treat patients and to improve their quality of life thru diagnosis, monitoring and therapy. New fields of study within Engineering are emerging throughout the academic community to better understand and improve these devices and tools. As a Systems Engineer what are we doing in this application that’s different from others? What are the challenges? What do we need to improve on? And Why?
This presentation provides an overview of the different types of Medical Devices and addresses the associated implications that affect the system under design. An example of a specific Medical Device will be presented along with a description of how the system integrates with Biological component. Systems Engineering Process comparison between Medical Device industry and Defense industry where Systems Engineering was conceived has been integrated throughout this presentation. You will learn more about some of the challenges that Medical Devices industry is facing and potential Systems Engineering solutions with specific approach and methodology.
Presented at the Zurich Frontend Conference (http://2014.frontendconf.ch/) on August 29th, 2014. Here I presented ideas on the integration of user experience in the growing trends of Internet of Things (IoT) devices and wearable sensors.
Module 01 Introduction To FdA and Quality System RegulationQACATX
An introduction to FDA and Quality System Regulations wherein participants will gain an understanding of the history of the Food and Drug Administration as well as an overview of Quality System Regulations.
Exploring medical device design and use through layers of Distributed Cognition
This presentation accompanies work presented in a paper by the same name: http://authors.elsevier.com/a/1QeZu5SMDQIJeU
DTx medical OEMs Can Achieve Commercial Mfg EfficiencyDTx Inc
Medical device manufacturers struggle to achieve the efficiency of high volume commercial manufacturers while adhering to stringent regulatory quality and traceability requirements. This presentation will demonstrate how to implement an automated manufacturing process control system that meets and surpasses ISO 13485 and FDA requirements in a lean manufacturing environment. With limited modifications to commercially available software, manufacturers can recognize benefits including: expedited new product introduction (NPI); reduced production costs; improved operating efficiency; and increased quality & traceability.
Design controls are not an easy subject to address during and after the design of medical devices and manufacturing processes. Design controls should drive the device design process, not be an afterthought. This session focuses on treating design as a separate entity within the quality management system, user needs vs. design inputs, continuation of design controls after the transfer process, design review and more.
Project Management Plan
Project Management Plan
Introduction
Project management planning involves defining, preparing, and coordinating all other subsidiary plans and integrating them to come up with one comprehensive plan. To make sure that the patient image wands being manufactured by PROVISION Healthcare Technologies is a success both from development, distribution and sales and marketing, the project management should be well consolidated .This will enable the project to be closely monitored. Project execution and controlling would be very much easier when there is a well documented management plan.
Product Development
The design and control process
During the development of the patient wands, the design and control process is very important. It is at this stage that procedures in the project plan are documented and incorporated during design and development of those patient wands.
The design team has the duties of doing the following:
· Identifying the customers’ needs
· Understanding the competitor’s product.
· Meeting essential requirements that is required to achieve a high quality product, from inception through to production.
· Identifying early inconsistencies or discrepancies by comparing what is currently made to the initial concept. This will help reduce redesigning and reworking. On the other hand, it will help improve product design and quality
· The design team should ensure that the end product will meet the customer needs.
Design and development planning process
At this stage, a plan that outlines the development activities while allocating individuals their duties and responsibilities is established and maintained .It is at this stage that the plan is reviewed, updated and approved. The software and hardware designs should be verified and be validated at this point.
Input Design
In order to come up with the best design, external ideas should be borrowed. It is during this phase that a survey of customers and other stakeholders for example nurses and clinicians should be done. Administering of questionnaires or interviewing can be conducted. The information gathered would be used to review, address and develop the specifications of the product.
Output Design
The output design procedures need to clearly refer to the input design that was earlier developed. The output design is expected to highlight the critical measures for proper functioning of the devices and software. Some of the output designs include:
· The hardware component
· user manual
· Specifications
· A risk analysis
· Study results which include validation and biocompatibility studies, storage and shipping tests
· Technical files
Design review
Design review is done to confirm the construction of the design. It is from here that deficiencies are detected and corrected .Hazard analysis review and failure mode analysis are the two common review analyses that can be done to ensure that the design is up to date. The design should be reviewe ...
The Business Case for Integrated Design ControlsGreenlight Guru
How leveraging these 4 approaches to FDA design controls will allow you to use them as a competitive advantage to reduce risk and get devices to market faster.
Read the full post: http://blog.greenlight.guru/business-case-design-controls
This is a small effort to simplify project/ business life cycle, steps and methodology.
It starts with the 'WILL' to do something, Ambition to start a new business or project or effort to enhance existing one. It explains the importance of market research, the outcomes, importance of business plans the execution strategy and what shall be done once the execution is completed.
It might not be the master piece representing the title yet it can be very helpful for the people who are willing and ready to take a challenge.
Without criticism, perfection is impossible. I request the critics to help me to bring betterment in next topics.
I shall be glad if I can be of further help in regards to the current topic in particular and related to business in general.
This is my small effort and contribution to make the world a better place by aligning & spreading the knowledge.
Looking forward to your feedback.
Asif Chaudhry
asifpannu@yahoo.com
ISO 26262, a functional safety standard, places a lot of emphasis on safety planning management. Learn from our Automotive Functional Safety Consultants the nuances of ISO 26262 compliant safety planning and its execution.
Introduction to software quality assurance by QuontraSolutionsQUONTRASOLUTIONS
Quontra Solutions provides QA training by Real time Industry experts. QA is having good demand in the market. Our QA online training Instructors are very much experienced and highly qualified and dedicated.
Our QA online training program is job oriented. After completion of QA training with us you should be able to work on any kind of project. After completion of QA online training our dedicated team will be supporting you.
Introduction: What is software engineering? Software Development Life Cycle, Requirements Analysis, Software Design, Coding, Testing, Maintenance etc.
Software Requirements: Functional and Non-functional requirements, User Requirements, System Requirements, Documentation of the software requirements.
Software Processes:
Process and Project, Component Software Processes.
Software Development Process Models.
Waterfall Model. Prototyping.
Iterative Development.
The RAD Model
"𝑩𝑬𝑮𝑼𝑵 𝑾𝑰𝑻𝑯 𝑻𝑱 𝑰𝑺 𝑯𝑨𝑳𝑭 𝑫𝑶𝑵𝑬"
𝐓𝐉 𝐂𝐨𝐦𝐬 (𝐓𝐉 𝐂𝐨𝐦𝐦𝐮𝐧𝐢𝐜𝐚𝐭𝐢𝐨𝐧𝐬) is a professional event agency that includes experts in the event-organizing market in Vietnam, Korea, and ASEAN countries. We provide unlimited types of events from Music concerts, Fan meetings, and Culture festivals to Corporate events, Internal company events, Golf tournaments, MICE events, and Exhibitions.
𝐓𝐉 𝐂𝐨𝐦𝐬 provides unlimited package services including such as Event organizing, Event planning, Event production, Manpower, PR marketing, Design 2D/3D, VIP protocols, Interpreter agency, etc.
Sports events - Golf competitions/billiards competitions/company sports events: dynamic and challenging
⭐ 𝐅𝐞𝐚𝐭𝐮𝐫𝐞𝐝 𝐩𝐫𝐨𝐣𝐞𝐜𝐭𝐬:
➢ 2024 BAEKHYUN [Lonsdaleite] IN HO CHI MINH
➢ SUPER JUNIOR-L.S.S. THE SHOW : Th3ee Guys in HO CHI MINH
➢FreenBecky 1st Fan Meeting in Vietnam
➢CHILDREN ART EXHIBITION 2024: BEYOND BARRIERS
➢ WOW K-Music Festival 2023
➢ Winner [CROSS] Tour in HCM
➢ Super Show 9 in HCM with Super Junior
➢ HCMC - Gyeongsangbuk-do Culture and Tourism Festival
➢ Korean Vietnam Partnership - Fair with LG
➢ Korean President visits Samsung Electronics R&D Center
➢ Vietnam Food Expo with Lotte Wellfood
"𝐄𝐯𝐞𝐫𝐲 𝐞𝐯𝐞𝐧𝐭 𝐢𝐬 𝐚 𝐬𝐭𝐨𝐫𝐲, 𝐚 𝐬𝐩𝐞𝐜𝐢𝐚𝐥 𝐣𝐨𝐮𝐫𝐧𝐞𝐲. 𝐖𝐞 𝐚𝐥𝐰𝐚𝐲𝐬 𝐛𝐞𝐥𝐢𝐞𝐯𝐞 𝐭𝐡𝐚𝐭 𝐬𝐡𝐨𝐫𝐭𝐥𝐲 𝐲𝐨𝐮 𝐰𝐢𝐥𝐥 𝐛𝐞 𝐚 𝐩𝐚𝐫𝐭 𝐨𝐟 𝐨𝐮𝐫 𝐬𝐭𝐨𝐫𝐢𝐞𝐬."
What are the main advantages of using HR recruiter services.pdfHumanResourceDimensi1
HR recruiter services offer top talents to companies according to their specific needs. They handle all recruitment tasks from job posting to onboarding and help companies concentrate on their business growth. With their expertise and years of experience, they streamline the hiring process and save time and resources for the company.
What is the TDS Return Filing Due Date for FY 2024-25.pdfseoforlegalpillers
It is crucial for the taxpayers to understand about the TDS Return Filing Due Date, so that they can fulfill your TDS obligations efficiently. Taxpayers can avoid penalties by sticking to the deadlines and by accurate filing of TDS. Timely filing of TDS will make sure about the availability of tax credits. You can also seek the professional guidance of experts like Legal Pillers for timely filing of the TDS Return.
Discover the innovative and creative projects that highlight my journey throu...dylandmeas
Discover the innovative and creative projects that highlight my journey through Full Sail University. Below, you’ll find a collection of my work showcasing my skills and expertise in digital marketing, event planning, and media production.
As a business owner in Delaware, staying on top of your tax obligations is paramount, especially with the annual deadline for Delaware Franchise Tax looming on March 1. One such obligation is the annual Delaware Franchise Tax, which serves as a crucial requirement for maintaining your company’s legal standing within the state. While the prospect of handling tax matters may seem daunting, rest assured that the process can be straightforward with the right guidance. In this comprehensive guide, we’ll walk you through the steps of filing your Delaware Franchise Tax and provide insights to help you navigate the process effectively.
Improving profitability for small businessBen Wann
In this comprehensive presentation, we will explore strategies and practical tips for enhancing profitability in small businesses. Tailored to meet the unique challenges faced by small enterprises, this session covers various aspects that directly impact the bottom line. Attendees will learn how to optimize operational efficiency, manage expenses, and increase revenue through innovative marketing and customer engagement techniques.
3.0 Project 2_ Developing My Brand Identity Kit.pptxtanyjahb
A personal brand exploration presentation summarizes an individual's unique qualities and goals, covering strengths, values, passions, and target audience. It helps individuals understand what makes them stand out, their desired image, and how they aim to achieve it.
Skye Residences | Extended Stay Residences Near Toronto Airportmarketingjdass
Experience unparalleled EXTENDED STAY and comfort at Skye Residences located just minutes from Toronto Airport. Discover sophisticated accommodations tailored for discerning travelers.
Website Link :
https://skyeresidences.com/
https://skyeresidences.com/about-us/
https://skyeresidences.com/gallery/
https://skyeresidences.com/rooms/
https://skyeresidences.com/near-by-attractions/
https://skyeresidences.com/commute/
https://skyeresidences.com/contact/
https://skyeresidences.com/queen-suite-with-sofa-bed/
https://skyeresidences.com/queen-suite-with-sofa-bed-and-balcony/
https://skyeresidences.com/queen-suite-with-sofa-bed-accessible/
https://skyeresidences.com/2-bedroom-deluxe-queen-suite-with-sofa-bed/
https://skyeresidences.com/2-bedroom-deluxe-king-queen-suite-with-sofa-bed/
https://skyeresidences.com/2-bedroom-deluxe-queen-suite-with-sofa-bed-accessible/
#Skye Residences Etobicoke, #Skye Residences Near Toronto Airport, #Skye Residences Toronto, #Skye Hotel Toronto, #Skye Hotel Near Toronto Airport, #Hotel Near Toronto Airport, #Near Toronto Airport Accommodation, #Suites Near Toronto Airport, #Etobicoke Suites Near Airport, #Hotel Near Toronto Pearson International Airport, #Toronto Airport Suite Rentals, #Pearson Airport Hotel Suites
India Orthopedic Devices Market: Unlocking Growth Secrets, Trends and Develop...Kumar Satyam
According to TechSci Research report, “India Orthopedic Devices Market -Industry Size, Share, Trends, Competition Forecast & Opportunities, 2030”, the India Orthopedic Devices Market stood at USD 1,280.54 Million in 2024 and is anticipated to grow with a CAGR of 7.84% in the forecast period, 2026-2030F. The India Orthopedic Devices Market is being driven by several factors. The most prominent ones include an increase in the elderly population, who are more prone to orthopedic conditions such as osteoporosis and arthritis. Moreover, the rise in sports injuries and road accidents are also contributing to the demand for orthopedic devices. Advances in technology and the introduction of innovative implants and prosthetics have further propelled the market growth. Additionally, government initiatives aimed at improving healthcare infrastructure and the increasing prevalence of lifestyle diseases have led to an upward trend in orthopedic surgeries, thereby fueling the market demand for these devices.
Taurus Zodiac Sign_ Personality Traits and Sign Dates.pptxmy Pandit
Explore the world of the Taurus zodiac sign. Learn about their stability, determination, and appreciation for beauty. Discover how Taureans' grounded nature and hardworking mindset define their unique personality.
Affordable Stationery Printing Services in Jaipur | Navpack n PrintNavpack & Print
Looking for professional printing services in Jaipur? Navpack n Print offers high-quality and affordable stationery printing for all your business needs. Stand out with custom stationery designs and fast turnaround times. Contact us today for a quote!
The world of search engine optimization (SEO) is buzzing with discussions after Google confirmed that around 2,500 leaked internal documents related to its Search feature are indeed authentic. The revelation has sparked significant concerns within the SEO community. The leaked documents were initially reported by SEO experts Rand Fishkin and Mike King, igniting widespread analysis and discourse. For More Info:- https://news.arihantwebtech.com/search-disrupted-googles-leaked-documents-rock-the-seo-world/
Business Valuation Principles for EntrepreneursBen Wann
This insightful presentation is designed to equip entrepreneurs with the essential knowledge and tools needed to accurately value their businesses. Understanding business valuation is crucial for making informed decisions, whether you're seeking investment, planning to sell, or simply want to gauge your company's worth.
[Note: This is a partial preview. To download this presentation, visit:
https://www.oeconsulting.com.sg/training-presentations]
Sustainability has become an increasingly critical topic as the world recognizes the need to protect our planet and its resources for future generations. Sustainability means meeting our current needs without compromising the ability of future generations to meet theirs. It involves long-term planning and consideration of the consequences of our actions. The goal is to create strategies that ensure the long-term viability of People, Planet, and Profit.
Leading companies such as Nike, Toyota, and Siemens are prioritizing sustainable innovation in their business models, setting an example for others to follow. In this Sustainability training presentation, you will learn key concepts, principles, and practices of sustainability applicable across industries. This training aims to create awareness and educate employees, senior executives, consultants, and other key stakeholders, including investors, policymakers, and supply chain partners, on the importance and implementation of sustainability.
LEARNING OBJECTIVES
1. Develop a comprehensive understanding of the fundamental principles and concepts that form the foundation of sustainability within corporate environments.
2. Explore the sustainability implementation model, focusing on effective measures and reporting strategies to track and communicate sustainability efforts.
3. Identify and define best practices and critical success factors essential for achieving sustainability goals within organizations.
CONTENTS
1. Introduction and Key Concepts of Sustainability
2. Principles and Practices of Sustainability
3. Measures and Reporting in Sustainability
4. Sustainability Implementation & Best Practices
To download the complete presentation, visit: https://www.oeconsulting.com.sg/training-presentations
Personal Brand Statement:
As an Army veteran dedicated to lifelong learning, I bring a disciplined, strategic mindset to my pursuits. I am constantly expanding my knowledge to innovate and lead effectively. My journey is driven by a commitment to excellence, and to make a meaningful impact in the world.
1. DESIGN AND DEVELOPMENT OF
MEDICAL DEVICE
Steps for Design & Development
The need of Design and Development in Medical device Industry and the main steps involved in the
process
Malesh M
www.i3cglobal.com
8/10/2013
2. DESIGN & DEVELOPMENT MEDICAL DEVICE
The requirements of Design and development
for Medical Device is
mentioned in ISO 13485 ,the organization should establish Documented
procedure for the design and development and should cover design and
development stages including review, verification ,validation and transfer.
DESIGN AND DEVELOPMENT PLANNING
Based on the information gathered in Product design request, design &
development planning is carried out by identifying design & development
stages & the target date. Design and development plan includes review,
verification & validation that are appropriate to the design & development
stages.
http://www.i3cglobal.com
+91 9900 3218 14
3. DESIGN & DEVELOPMENT INPUTS
Inputs related to the product (system specification & product specification)
are determined & recorded in Product design request. Functional
performance requirements, applicable statutory / regulatory requirements
,competitors specification are considered for design & development inputs.
DESIGN AND DEVELOPMENT OUTPUTS
Following are the design & development outputs:
i Drawings.
ii. Bill of material.
iii. Quality plan.
iv. Quality inspection reports.
http://www.i3cglobal.com
+91 9900 3218 14
4. v. Instruction production & QA.
Design calculations for the system / product are recorded in the design work
sheet Work sheet Design & development outputs are reviewed so that they
meet input requirements.
DESIGN AND DEVELOPMENT REVIEW
At suitable stages as indicated in the design & development planning,
systematic reviews are conducted to evaluate the ability of design to meet
the input requirements & identify any problems for necessary actions by the
technical team. These reviews are recorded in the design & development
record
http://www.i3cglobal.com
+91 9900 3218 14
5. DESIGN AND DEVELOPMENT VERIFICATION
Verification of design is carried out by QA inspecting & testing for the
subsistence of design to ensure that the design and development outputs
have met the design and development input requirements.
DESIGN AND DEVELOPMENT VALIDATION
Validation is performed to ensure that the resulting product is capable of
meeting the requirements for the specified application or intended use.
Records of the results of validation are maintained in the validation report.
CONTROL OF DESIGN AND DEVELOPMENT CHANGES
Design & development change requested by any department is recorded in
the design change review format and is forwarded review & approval.
http://www.i3cglobal.com
+91 9900 3218 14
6. DESIGN & DEVELOPMENT MEDICAL DEVICE
DESIGN AND
DEVELOPMENT PLANNING
DESIGN AND DEVELOPMENT
VALIDATION
CONTROL OF DESIGN AND
DEVELOPMENT CHANGES
http://www.i3cglobal.com
DESIGN & DEVELOPMENT
INPUTS
DESIGN AND DEVELOPMENT
VERIFICATION
DESIGN AND DEVELOPMENT
OUTPUTS
DESIGN AND
DEVELOPMENT REVIEW
DESIGN TRANSFER
+91 9900 3218 14