Farm is an ISO 13485-certified and FDA-compliant product development consultancy with over 40 years of experience helping medical, life sciences, and consumer healthcare companies. It offers expertise in areas like user research, engineering, design, and regulatory compliance. Farm helps clients design devices that are safe, easy to use and effective by employing research, usability testing, and a process-driven development approach.
5 Predictions for the Medical Device Industry in 2018 (and how you can prepare)Greenlight Guru
What should the medical device industry expect in 2018?
Great question.
From ISO 13485 being revised in 2016, the EU MDR / IVDR being revised in 2017, and the MDSAP program going live in 2017, regulatory changes have been rampant and significant for medical device professionals.
This presentation covers:
- Why you should expect it to be harder for devices to get to market and stay there in the EU
- How to avoid the mad dash to update ISO 13485 certification before the deadline
- Where the latest revision of ISO 14971 is and when to expect the next update
- About Health Canada and their MDSAP deadline
- Why companies are shifting from being compliance-focused to quality-focused
Watch the presentation, commentated by Greenlight Guru's founder Jon Speer, here: https://www.greenlight.guru/webinar/2018-medical-device-industry-predictions
How Design Controls & Risk Management Best Practices Reduce Customer Complain...Greenlight Guru
We all know how much emphasis FDA inspectors and ISO auditors place on your customer complaint and CAPA processes. And rightfully so.
But what if there were things you could do to minimize the struggles and challenges associated with customer complaint and CAPA management?
Good news. You can decrease the number of customer complaints and reduce the volume of issued CAPAs through good product development Design Controls and Risk Management practices.
Specifically this presentation will cover:
-Influence Design Controls has on Customer Complaints
-How Customer Complaints impact your CAPA system
-Best practices for Design Controls
-Best practices for Risk Management
-Risk-based approaches to Customer Complaint and CAPA management
Bridging User Needs & Design Requirements: Answers are Only as Good as the Qu...Greenlight Guru
We did the surgery perfectly, yet the patient died anyway… we designed the medical device perfectly, yet the patient died anyway… we followed the regulation perfectly, yet the patient died anyway.
All are iterations on the same theme, i.e., all have the same root cause: answers are only as good as the questions we ask!
Or put another way: what good is designing the right medical device if we are solving the wrong problem?
Is regulatory and quality simply about making sure your design inputs match your user needs, i.e., ticking the boxes? What if your user needs are wrong? Do we need regulation to require us to make sure we are solving the right problems? asking the right questions?
Regulation is all about the interpretation of words and your ability to defend your interpretation.
Using the case study approach, this presentation will cover:
-What is a design input and how do we make sure we have the right ones?
-What's the relationship between design inputs and user needs?
-How do we turn “user inputs” into a viable product and more importantly the right product!
-How do we “translate” user needs to design requirements? Can regs helps?
-How to read between the lines of user feedback, i.e., wants vs. needs?
-How do we sync design requirements and user needs?
-What are the challenges for the future?
Learn more, and watch the presentation, here: https://www.greenlight.guru/webinar/bridging-user-needs-design-requirements
FDA's Case for Quality: What, Why, and How? Changing the Regulatory ParadigmGreenlight Guru
Top-quality medical devices help the FDA better protect and promote public health. And one of the top priorities for FDA's medical devices center is a focus on quality.
The FDA launched the Case for Quality in 2011 following an in-depth review of device quality data and feedback from both FDA and industry stakeholders.
This program allows the FDA to recognize device manufacturers that are capable of consistently producing high-quality devices and continuously improving.
Greenlight Guru is partnering with FDA CDRH to help spread the word and promote the Case for Quality initiative and its benefits to the medical device industry. This is the first of four presentations, learn about the others at greenlight.guru.
Key points in this presentation:
-Learn about CfQ – What it is, why we are doing it, and how we are engaging
-Introduce pilot programs – Provide summary detail on various pilots at CDRH and associated with CfQ
-Regulatory paradigm – How is FDA rethinking the regulatory engagement
Watch this presentation, by Franciso Vicenty, the Case for Quality Manager of the FDA, here: https://www.greenlight.guru/webinar/fda-case-for-quality
How to Prepare for the New EU In Vitro Diagnostics RegulationsGreenlight Guru
Agreement was reached on the eagerly awaited new EU In Vitro Diagnostic Regulations (IVDR) earlier this year.
The IVDR will significantly change the way IVDs bear the CE mark, and it will include a completely new risk-based classification system.
Now 80% of all IVDs will need to be certified by a notified body under the IVDR where as before, only 20% needed to under the IVD Directive.
The new IVDR is expected to be formally published in late 2016 or early 2017, and there will be a five-year transition period to be compliant.
Many forward thinking IVD companies are already developing their plans for compliance now to gain strategic advantages over their competitors.
This presentation includes:
-Why the European regulations are changing
-What does the new regulation mean for IVD manufactures
-How to classify your IVD using the new risk-based classification system
-How to evaluate your existing clinical evidence to know if new studies will be needed to support your CE mark
-An overview of all the most significant changes brought by the IVDR
-What IVD manufactures can do to start preparing now
Watch the presentation here: https://www.greenlight.guru/webinar/eu-in-vitro-diagnostic-regulations-ivdr
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.
5 Predictions for the Medical Device Industry in 2018 (and how you can prepare)Greenlight Guru
What should the medical device industry expect in 2018?
Great question.
From ISO 13485 being revised in 2016, the EU MDR / IVDR being revised in 2017, and the MDSAP program going live in 2017, regulatory changes have been rampant and significant for medical device professionals.
This presentation covers:
- Why you should expect it to be harder for devices to get to market and stay there in the EU
- How to avoid the mad dash to update ISO 13485 certification before the deadline
- Where the latest revision of ISO 14971 is and when to expect the next update
- About Health Canada and their MDSAP deadline
- Why companies are shifting from being compliance-focused to quality-focused
Watch the presentation, commentated by Greenlight Guru's founder Jon Speer, here: https://www.greenlight.guru/webinar/2018-medical-device-industry-predictions
How Design Controls & Risk Management Best Practices Reduce Customer Complain...Greenlight Guru
We all know how much emphasis FDA inspectors and ISO auditors place on your customer complaint and CAPA processes. And rightfully so.
But what if there were things you could do to minimize the struggles and challenges associated with customer complaint and CAPA management?
Good news. You can decrease the number of customer complaints and reduce the volume of issued CAPAs through good product development Design Controls and Risk Management practices.
Specifically this presentation will cover:
-Influence Design Controls has on Customer Complaints
-How Customer Complaints impact your CAPA system
-Best practices for Design Controls
-Best practices for Risk Management
-Risk-based approaches to Customer Complaint and CAPA management
Bridging User Needs & Design Requirements: Answers are Only as Good as the Qu...Greenlight Guru
We did the surgery perfectly, yet the patient died anyway… we designed the medical device perfectly, yet the patient died anyway… we followed the regulation perfectly, yet the patient died anyway.
All are iterations on the same theme, i.e., all have the same root cause: answers are only as good as the questions we ask!
Or put another way: what good is designing the right medical device if we are solving the wrong problem?
Is regulatory and quality simply about making sure your design inputs match your user needs, i.e., ticking the boxes? What if your user needs are wrong? Do we need regulation to require us to make sure we are solving the right problems? asking the right questions?
Regulation is all about the interpretation of words and your ability to defend your interpretation.
Using the case study approach, this presentation will cover:
-What is a design input and how do we make sure we have the right ones?
-What's the relationship between design inputs and user needs?
-How do we turn “user inputs” into a viable product and more importantly the right product!
-How do we “translate” user needs to design requirements? Can regs helps?
-How to read between the lines of user feedback, i.e., wants vs. needs?
-How do we sync design requirements and user needs?
-What are the challenges for the future?
Learn more, and watch the presentation, here: https://www.greenlight.guru/webinar/bridging-user-needs-design-requirements
FDA's Case for Quality: What, Why, and How? Changing the Regulatory ParadigmGreenlight Guru
Top-quality medical devices help the FDA better protect and promote public health. And one of the top priorities for FDA's medical devices center is a focus on quality.
The FDA launched the Case for Quality in 2011 following an in-depth review of device quality data and feedback from both FDA and industry stakeholders.
This program allows the FDA to recognize device manufacturers that are capable of consistently producing high-quality devices and continuously improving.
Greenlight Guru is partnering with FDA CDRH to help spread the word and promote the Case for Quality initiative and its benefits to the medical device industry. This is the first of four presentations, learn about the others at greenlight.guru.
Key points in this presentation:
-Learn about CfQ – What it is, why we are doing it, and how we are engaging
-Introduce pilot programs – Provide summary detail on various pilots at CDRH and associated with CfQ
-Regulatory paradigm – How is FDA rethinking the regulatory engagement
Watch this presentation, by Franciso Vicenty, the Case for Quality Manager of the FDA, here: https://www.greenlight.guru/webinar/fda-case-for-quality
How to Prepare for the New EU In Vitro Diagnostics RegulationsGreenlight Guru
Agreement was reached on the eagerly awaited new EU In Vitro Diagnostic Regulations (IVDR) earlier this year.
The IVDR will significantly change the way IVDs bear the CE mark, and it will include a completely new risk-based classification system.
Now 80% of all IVDs will need to be certified by a notified body under the IVDR where as before, only 20% needed to under the IVD Directive.
The new IVDR is expected to be formally published in late 2016 or early 2017, and there will be a five-year transition period to be compliant.
Many forward thinking IVD companies are already developing their plans for compliance now to gain strategic advantages over their competitors.
This presentation includes:
-Why the European regulations are changing
-What does the new regulation mean for IVD manufactures
-How to classify your IVD using the new risk-based classification system
-How to evaluate your existing clinical evidence to know if new studies will be needed to support your CE mark
-An overview of all the most significant changes brought by the IVDR
-What IVD manufactures can do to start preparing now
Watch the presentation here: https://www.greenlight.guru/webinar/eu-in-vitro-diagnostic-regulations-ivdr
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.
#Imported or Locally Manufactured #medicines without proper pre & post inspection may be rendered substandard at any point along the #medical supply chain, from the point of manufacture through the point of distribution. Regardless of where along the supply chain substandard #medicines are compromised, they pose serious public health risks. for more details please visit on:http://www.stabicon.com/
Design Controls: Building Objective Evidence and Process Architecture to Mee...April Bright
This session provides detailed examples to demonstrate what objective evidence is important to generate and use during design control compliance but, more importantly, to develop and issue a beneficial design history file meeting the requirements in 21 CFR, Part 820.30 and ISO 13485:2016. Aside from the importance of design controls for compliance, Mr. Gagliardi demonstrates how this section of the QS regulation and the ISO standard can be facilitated as a leading edge business tool.
FDA Update: Inspections, Observations and Metrics - OMTEC 2017April Bright
This FDA-focused presentation offers a glimpse into trends behind three initiatives that orthopaedic device professionals need to fully understand: inspections, Case for Quality and 483 Observations. First, a high-level view of FDA inspections will discuss methodology and implementation. Second, FDA’s observations of non-compliance will be discussed, pointing out important historical trends. Finally, as the industry matures, professionals should expect changes to the breadth and depth of FDA’s focus. This is where Case for Quality and the Medical Device Metrics Initiative will be covered. FDA has placed an increased emphasis on data and metrics. Gain insight into ways to leverage data to improve, monitor and control processes that drive quality improvement.
We’re pleased to announce that the Conference and Workshop programme for ISPE Singapore is ready to view on www.ispesingapore.org
FINAL BROCHURE NOW AVAILABLE FOR DOWNLOAD HERE!
This year, you’ll find:
• 90% NEW & 50% MORE Speakers than in 2013
• Over 34 presenters sharing their case studies and experience
• Choose from 36 hours of Learning, 6 hours of Networking Across the Plenary Conference & 9 practical workshops
• The latest solutions at the ISPE Singapore Exhibition on 23-24 June
• And don’t forget to sign up for the Site Visit to MSD Singapore Plant Extension!
Build your own agenda from 3 concurrent sessions:
Sunday 22 June (1.30-5.30pm):
A: Quality / Validation
B: Operational Excellence
C: Bio / Sterile / Clean Utilities
Monday 23 June (2.00-5.45pm):
D: Tech Transfer / Process Validation
E: QBD / PAT
F: Sterile Operations
Tuesday 23 June (9.00-3.30pm):
G: Quality / Audit / Regulatory
H: Operational Excellence / Lean Manufacturing
J: Biologics
OSMA: Orthopedic Industry's Top Regulatory Challenges and OpportunitiesApril Bright
The Orthopaedic Surgical Manufacturers Association, a collective voice of orthopedic device companies that influences the decision of worldwide regulatory agencies and standards bodies, will highlight the main regulatory changes impacting the industry. This session is for any orthopedic professional who wants a forecast of regulatory pressures and seeks direction on how to shape change. Attendees will learn how FDA, European agencies and IMDRF are approaching harmonization and alignment of standards, regulations and guidance. OSMA Members will provide future trends and opportunities afforded via FDA’s National Evaluation System for Health Technology (NEST), facilitation of innovation through partnerships and global harmonization of regulatory submissions and facility assessments.
Computational Modeling & Simulation in Orthopedics: Tools to Comply in an Ev...April Bright
Computational Modeling & Simulation has the ability to revolutionize the orthopedic device industry by reducing and in some instances eliminating the need for benchtop testing and clinical trials. Dr. Afshari shared his experience in establishing the credibility of computational models for product design and development purposes, and highlighted was that modeling fits with the regulatory and standards framework.
Regulatory and Quality Affairs: Answers to FDA and ISO Gray AreasApril Bright
Every day, people like you in companies everywhere are sidetracked from more pressing priorities by questions and scenarios that aren’t clearly explained in a regulation or standard (a.k.a. "gray areas"). This panel of regulatory and quality experts were charged with mitigating your roadblocks and getting you on your way. Our panel shared their perspective on the pressing questions received from a pre-conference attendee questionnaire, including UDI and supplier relationships.
FDA Inspections are Different from ISO Audits, So Don't Treat Them the Same -...April Bright
ISO audits and FDA inspections differ logistically, and should be approached in different manners. This presentation will explain the real-time differences between the two and, most importantly, give you strategies for preparation, behavioral tips for success during and after the assessments and recommendations for responding to the Registrar or FDA if deficiencies were discovered.
Accelerating Post-approval Change Management with ICH Q12Veeva Systems
Adopting ICH Q12 and modern technologies can reduce the number of changes that require regulatory approval as well as accelerate evaluation, implementation, and global approval of a change. In a 2017 PDA survey, almost 40% of respondents said that 50% or more of their post-approval changes required submission to a health authority. With increasing complexity in the manufacturing of new therapies and growing number of changes that require filing review and updates in multiple markets, the global post-approval change management (PACM) process is becoming unmanageable.
Modern technologies are reducing complexity in pharma by bringing together systems and people to seamlessly support global, end-to-end processes. With greater visibility and collaboration, change management processes are more efficient and less risky. In this webinar, learn:
What is ICH Q12 and potential benefits
Best practices and approaches to key PACM challenges
Approaches to manage ‘established conditions’
How technology can support ICH Q12 and simplify change management
Innovative ways leading pharma companies are addressing PACM
Leverage Computational Modeling and Simulation for Device Design - OMTEC 2017April Bright
Computational modeling and simulation (CM&S) has the potential to revolutionize medical devices by accelerating innovation and providing comprehensive evidence of long-term safety. For example, CM&S can provide performance benchmarks, assess design parameter interdependencies, evaluate a variety of use conditions, provide visualization of complex processes and become a core element of device submissions and approvals. This presentation will begin with an overview of the use of CM&S throughout the orthopaedic implant lifecycle, followed by a review of the current regulatory direction regarding the use of CM&S in device submissions. Next, a series of case studies based on a variety of orthopaedic implants will demonstrate the application of CM&S at various phases of the product lifecycle in more detail. The examples will also highlight the effects of modeling assumptions on model credibility and some verification and validation best practices.
This presentation will position CM&S as a credible and common means for device companies and FDA to demonstrate the safety of medical devices, and thereby ensure safety, reduce cost and accelerate the pathway toward “first in the world” access to products in the U.S.
This webinar will provide valuable guidance to regulated companies in development and implementation of formal, defined, documented methods for analysis of product changes and when to file a new 510(k). Consideration of the U.S . FDA's current K-97-1 Memo / guidance document on "510(k) Device Modifications"
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
What You Need to Know About Medical Electrical Standards Updates (and how the...Greenlight Guru
Medical Electrical Standards are constantly being updating.
So how do you stay up-to-date on all these changes? Are you considering the implication of these standards when putting together your regulatory strategy? Do you know what standards are coming down the line and how they may impact your product design? Are these standards harmonized in different markets? Does your test lab always know what versions of standards you need to test too?
This presentation will cover:
-What medical electrical and related standards are being updated now and how they interact with each other.
-What is the schedule for the IEC 60601 Amendment Projects and what other standards (i.e. ISO 14971, IEC 62366-1, IEC 62304) will impact the project?
-Overview of the recently released Wireless Coexistence Standards for US.
-Why you may need to redesign your product to meet the EMC Standard IEC 60601-1-2:2014 (4th Ed.).
-How does testing under the CB Scheme impact your testing and regulatory strategies?
-Resources to keep track of standards from both a regulatory and standards development perspective.
Watch the presentation here: https://www.greenlight.guru/webinar/medical-electrical-standards-updates
Medical Device Development - Concept to Commercialization | Jahnavi Lokre | L...UCICove
About UCI Applied Innovation:
UCI Applied Innovation is a dynamic, innovative central platform for the UCI campus, entrepreneurs, inventors, the business community and investors to collaborate and move UCI research from lab to market.
About the Cove @ UCI:
To accelerate collaboration by better connecting innovation partners in Orange County, UCI Applied Innovation created the Cove, a physical, state-of-the-art hub for entrepreneurs to gather and navigate the resources available both on and off campus. The Cove is headquarters for UCI Applied Innovation, as well as houses several ecosystem partners including incubators, accelerators, angel investors, venture capitalists, mentors and legal experts.
Follow us on social media:
Facebook: @UCICove
Twitter: @UCICove
Instagram: @UCICove
LinkedIn: @UCIAppliedInnovation
For more information:
cove@uci.edu
http://innovation.uci.edu/
Easing the Secondary Production Process During Design: The design stage is where the smart decisions are made in additive manufacturing — not only on ways to increase clinical outcomes and additive processes, but also to ease post-processing. In these areas, the process can be made efficient and cost-effective. Receive tips and tricks on orientation, supports, stock material and design features.
Enhancing Design through Engineering and Manufacturing Collaboration: Unlike conventional methods, additive manufacturing requires design and manufacturing teams to work closely together very early in the design phase. In a world where the pace of innovation is nearly vertical, it’s imperative to understand this concept early to make additive manufacturing work for you. This discussion lends a high-level overview of best practices when working with internal or external suppliers, and shows examples of the use of additive manufacturing to create innovative medical device designs.
#Imported or Locally Manufactured #medicines without proper pre & post inspection may be rendered substandard at any point along the #medical supply chain, from the point of manufacture through the point of distribution. Regardless of where along the supply chain substandard #medicines are compromised, they pose serious public health risks. for more details please visit on:http://www.stabicon.com/
Design Controls: Building Objective Evidence and Process Architecture to Mee...April Bright
This session provides detailed examples to demonstrate what objective evidence is important to generate and use during design control compliance but, more importantly, to develop and issue a beneficial design history file meeting the requirements in 21 CFR, Part 820.30 and ISO 13485:2016. Aside from the importance of design controls for compliance, Mr. Gagliardi demonstrates how this section of the QS regulation and the ISO standard can be facilitated as a leading edge business tool.
FDA Update: Inspections, Observations and Metrics - OMTEC 2017April Bright
This FDA-focused presentation offers a glimpse into trends behind three initiatives that orthopaedic device professionals need to fully understand: inspections, Case for Quality and 483 Observations. First, a high-level view of FDA inspections will discuss methodology and implementation. Second, FDA’s observations of non-compliance will be discussed, pointing out important historical trends. Finally, as the industry matures, professionals should expect changes to the breadth and depth of FDA’s focus. This is where Case for Quality and the Medical Device Metrics Initiative will be covered. FDA has placed an increased emphasis on data and metrics. Gain insight into ways to leverage data to improve, monitor and control processes that drive quality improvement.
We’re pleased to announce that the Conference and Workshop programme for ISPE Singapore is ready to view on www.ispesingapore.org
FINAL BROCHURE NOW AVAILABLE FOR DOWNLOAD HERE!
This year, you’ll find:
• 90% NEW & 50% MORE Speakers than in 2013
• Over 34 presenters sharing their case studies and experience
• Choose from 36 hours of Learning, 6 hours of Networking Across the Plenary Conference & 9 practical workshops
• The latest solutions at the ISPE Singapore Exhibition on 23-24 June
• And don’t forget to sign up for the Site Visit to MSD Singapore Plant Extension!
Build your own agenda from 3 concurrent sessions:
Sunday 22 June (1.30-5.30pm):
A: Quality / Validation
B: Operational Excellence
C: Bio / Sterile / Clean Utilities
Monday 23 June (2.00-5.45pm):
D: Tech Transfer / Process Validation
E: QBD / PAT
F: Sterile Operations
Tuesday 23 June (9.00-3.30pm):
G: Quality / Audit / Regulatory
H: Operational Excellence / Lean Manufacturing
J: Biologics
OSMA: Orthopedic Industry's Top Regulatory Challenges and OpportunitiesApril Bright
The Orthopaedic Surgical Manufacturers Association, a collective voice of orthopedic device companies that influences the decision of worldwide regulatory agencies and standards bodies, will highlight the main regulatory changes impacting the industry. This session is for any orthopedic professional who wants a forecast of regulatory pressures and seeks direction on how to shape change. Attendees will learn how FDA, European agencies and IMDRF are approaching harmonization and alignment of standards, regulations and guidance. OSMA Members will provide future trends and opportunities afforded via FDA’s National Evaluation System for Health Technology (NEST), facilitation of innovation through partnerships and global harmonization of regulatory submissions and facility assessments.
Computational Modeling & Simulation in Orthopedics: Tools to Comply in an Ev...April Bright
Computational Modeling & Simulation has the ability to revolutionize the orthopedic device industry by reducing and in some instances eliminating the need for benchtop testing and clinical trials. Dr. Afshari shared his experience in establishing the credibility of computational models for product design and development purposes, and highlighted was that modeling fits with the regulatory and standards framework.
Regulatory and Quality Affairs: Answers to FDA and ISO Gray AreasApril Bright
Every day, people like you in companies everywhere are sidetracked from more pressing priorities by questions and scenarios that aren’t clearly explained in a regulation or standard (a.k.a. "gray areas"). This panel of regulatory and quality experts were charged with mitigating your roadblocks and getting you on your way. Our panel shared their perspective on the pressing questions received from a pre-conference attendee questionnaire, including UDI and supplier relationships.
FDA Inspections are Different from ISO Audits, So Don't Treat Them the Same -...April Bright
ISO audits and FDA inspections differ logistically, and should be approached in different manners. This presentation will explain the real-time differences between the two and, most importantly, give you strategies for preparation, behavioral tips for success during and after the assessments and recommendations for responding to the Registrar or FDA if deficiencies were discovered.
Accelerating Post-approval Change Management with ICH Q12Veeva Systems
Adopting ICH Q12 and modern technologies can reduce the number of changes that require regulatory approval as well as accelerate evaluation, implementation, and global approval of a change. In a 2017 PDA survey, almost 40% of respondents said that 50% or more of their post-approval changes required submission to a health authority. With increasing complexity in the manufacturing of new therapies and growing number of changes that require filing review and updates in multiple markets, the global post-approval change management (PACM) process is becoming unmanageable.
Modern technologies are reducing complexity in pharma by bringing together systems and people to seamlessly support global, end-to-end processes. With greater visibility and collaboration, change management processes are more efficient and less risky. In this webinar, learn:
What is ICH Q12 and potential benefits
Best practices and approaches to key PACM challenges
Approaches to manage ‘established conditions’
How technology can support ICH Q12 and simplify change management
Innovative ways leading pharma companies are addressing PACM
Leverage Computational Modeling and Simulation for Device Design - OMTEC 2017April Bright
Computational modeling and simulation (CM&S) has the potential to revolutionize medical devices by accelerating innovation and providing comprehensive evidence of long-term safety. For example, CM&S can provide performance benchmarks, assess design parameter interdependencies, evaluate a variety of use conditions, provide visualization of complex processes and become a core element of device submissions and approvals. This presentation will begin with an overview of the use of CM&S throughout the orthopaedic implant lifecycle, followed by a review of the current regulatory direction regarding the use of CM&S in device submissions. Next, a series of case studies based on a variety of orthopaedic implants will demonstrate the application of CM&S at various phases of the product lifecycle in more detail. The examples will also highlight the effects of modeling assumptions on model credibility and some verification and validation best practices.
This presentation will position CM&S as a credible and common means for device companies and FDA to demonstrate the safety of medical devices, and thereby ensure safety, reduce cost and accelerate the pathway toward “first in the world” access to products in the U.S.
This webinar will provide valuable guidance to regulated companies in development and implementation of formal, defined, documented methods for analysis of product changes and when to file a new 510(k). Consideration of the U.S . FDA's current K-97-1 Memo / guidance document on "510(k) Device Modifications"
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
What You Need to Know About Medical Electrical Standards Updates (and how the...Greenlight Guru
Medical Electrical Standards are constantly being updating.
So how do you stay up-to-date on all these changes? Are you considering the implication of these standards when putting together your regulatory strategy? Do you know what standards are coming down the line and how they may impact your product design? Are these standards harmonized in different markets? Does your test lab always know what versions of standards you need to test too?
This presentation will cover:
-What medical electrical and related standards are being updated now and how they interact with each other.
-What is the schedule for the IEC 60601 Amendment Projects and what other standards (i.e. ISO 14971, IEC 62366-1, IEC 62304) will impact the project?
-Overview of the recently released Wireless Coexistence Standards for US.
-Why you may need to redesign your product to meet the EMC Standard IEC 60601-1-2:2014 (4th Ed.).
-How does testing under the CB Scheme impact your testing and regulatory strategies?
-Resources to keep track of standards from both a regulatory and standards development perspective.
Watch the presentation here: https://www.greenlight.guru/webinar/medical-electrical-standards-updates
Medical Device Development - Concept to Commercialization | Jahnavi Lokre | L...UCICove
About UCI Applied Innovation:
UCI Applied Innovation is a dynamic, innovative central platform for the UCI campus, entrepreneurs, inventors, the business community and investors to collaborate and move UCI research from lab to market.
About the Cove @ UCI:
To accelerate collaboration by better connecting innovation partners in Orange County, UCI Applied Innovation created the Cove, a physical, state-of-the-art hub for entrepreneurs to gather and navigate the resources available both on and off campus. The Cove is headquarters for UCI Applied Innovation, as well as houses several ecosystem partners including incubators, accelerators, angel investors, venture capitalists, mentors and legal experts.
Follow us on social media:
Facebook: @UCICove
Twitter: @UCICove
Instagram: @UCICove
LinkedIn: @UCIAppliedInnovation
For more information:
cove@uci.edu
http://innovation.uci.edu/
Easing the Secondary Production Process During Design: The design stage is where the smart decisions are made in additive manufacturing — not only on ways to increase clinical outcomes and additive processes, but also to ease post-processing. In these areas, the process can be made efficient and cost-effective. Receive tips and tricks on orientation, supports, stock material and design features.
Enhancing Design through Engineering and Manufacturing Collaboration: Unlike conventional methods, additive manufacturing requires design and manufacturing teams to work closely together very early in the design phase. In a world where the pace of innovation is nearly vertical, it’s imperative to understand this concept early to make additive manufacturing work for you. This discussion lends a high-level overview of best practices when working with internal or external suppliers, and shows examples of the use of additive manufacturing to create innovative medical device designs.
Medical Device and Diagnostics Solutions for Every Stage of Your Product's De...Covance
Getting a medical device to the patient takes more than good technology in today's environment. Compelling evidence and convincing value proposition matter. Competing priorities and differing stakeholder definitions of value are driving the need for creative, connected strategies to get the most from each step in the development process. And - as evidence is gathered - it should be used to inform and iterate regulatory, reimbursement and clinical post-market strategies.
The critical role of QA in Medical Device Testing.pdfMindfire LLC
Digitization has brought significant advancements to the healthcare industry in recent years. This has made it easier to connect people with the most up-to-date medical gadgets and software, resulting in better healthcare services. Medical devices are essential for patient care because they have a direct impact on human lives by delivering valuable data and observations.
Due to different advancements in healthcare, medical device software continues to get increasingly sophisticated. Certain critical compliance factors, such as regulatory delays and the adoption of international standards, have an impact on the software quality of medical devices.
We have a unique profile for a CRO providing distinctive and innovative dual expertise by combining clinical research implementation with the development of customized IT applications specific to the pharmaceutical industry.
Stabicon has been ambitiously established in 2010. Professionally managed with 75 scientists from diverse background expertise. Our organization is specialized in managing product quality process, upgrading and introducing advanced technology into products. we are proud to lay a foundation for prosperous future in prevention and cure segment, future medicine & FMCG business.
UX Antwerp Meetup, 27th of September 2016 - Carolien Creemers, Functional Analyst et Nobel Biocare
"UX design for better patient care"
When developing medical device software, UX design is more than facilitating a positive user experience. It is also about preventing your design decisions from leading to any patient harm. In this talk, Carolien will outline the challenges and risks that arise when designing software for daily clinical use.
She will give you some practical insights on how the team at Nobel Biocare developed a UX process in line with ISO and FDA regulations that delivers software which is not only easy to use but also safe to use.
“The Most Recommended Pharma & Life Sciences Solution providers in 2021” highlighting the pharmaceutical and healthcare industries help to improving the human health and forwarding life-expectancy one step further.
EMEA Edison™ Accelerator Application Support WebinarWayra UK
The EMEA Edison™ Accelerator is a start-up and scale-up acceleration & healthcare provider collaboration programme designed by GE Healthcare in partnership with Wayra UK. It brings together healthcare providers, start-ups and scale-ups who want to leverage the GE Healthcare environment and mentoring to enhance their value proposition.
The 10 Most Innovative Pharma and Biotech Solution Providers, 2020 September ...Merry D'souza
The 10 most innovative pharma and biotech solution providers, 2020 september 2020; Insights Success has published The 10 most innovative pharma and biotech solution providers.
"Electra HIS" is developed & promoted by ACG Infotech Limited, a NASSCOM Company under the guidance of professional medical doctors. Electra HIS, is fully integrated and possesses the ability to share and exchange information across the platforms in real time and make the hospital paperless. Electra HIS is multi-location application complied with following Standards.
2. DJO Global | Aircast®
AirSelectTM
Premium User Experience
Farm helped DJO Global become a leader in the category of orthopedic therapy
products by developing the innovative Aircast®
walking cast. Farm has recently
helped DJO Global build on that success by creating AirSelectTM
, a breakthrough
addition to the DJO Global product family that brings significant improvements
in both product performance and user comfort. Farm’s technical team developed
the new sole design using wearable prototypes, advanced real-time testing, and
computerized motion path analysis. The result is a more comfortable product that
helps the patient walk with a more natural gait.
NinePoint Medical | NvisionVLETM
Imaging System
Seeing Below the Surface
Farm collaborated with startup biotech firm NinePoint Medical to develop the
NvisionVLETM
Imaging System, a breakthrough diagnostic tool that uses Optical
Coherence Tomography to allow clinicians to more precisely evaluate the tissue
microstructure of the esophagus during a standard endoscopy procedure.
Farm helped NinePoint Medical progress from concept breadboard to a commercial
product in less than a year, creating a device that achieves a new level of precision
in tissue visualization.
Cook Medical | NavAlignTM
IVC Filter Delivery System
Improving Device Efficacy
Farm helped Cook Medical redesign their existing inferior vena cava (IVC) filter
delivery system to make it easier for cardiologists to deliver these life-saving vascular
implants. The new product eliminates the effects of pull/push and rotation on the
filter, reducing the potential for misalignment, and a unique tactile feedback feature
allows the surgeon to focus on the monitor and eliminate premature deployment.
We also reduced the number of steps needed to complete the delivery of the filter,
and engineered the product to be more cost-effective to manufacture.
The NavAlignTM
IVC Filter Delivery System features more precise control, increased
accuracy, and improved device efficacy.