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Quality speaks
If something is important enough, even if the odds are against you, you should still do it.
Elon Musk
Elon Musk
Professional Development Meeting:
Speaker: Scott Collins
Tuesday, June 11 2024
Presentation: 7:00pm
Location: Webinar (zoom link sent via email to members)
UDI: FDA vs. EU Topic
In 2013 the FDA passed its UDI directive for the identification of medical devices. The European Union (EU) Commission followed suit in 2017 with a rewriting of the Medical Device Directive to the new Medical Device Regulation (MDR). Both regulatory bodies applied a staged approach to enforcement of the requirements in their respective regions. The FDA UDI requirements are now in full force requiring full UDI on both the labels and reusable devices themselves. The EU MDR was fully applicable in 2021 and is currently in the middle of their UDI implementation schedule. Class III, IIb, and Class IIa devices should already have the UDI on the labels, with Class I labels following in 2025. The UDI should already be marked on reusable Class III devices with reusable Class IIa and Class IIb following in 2025, and reusable Class I devices in 2027. What are the differences between the FDA UDI requirements and the EU UDI requirements? Let’s take a minute to review
Speaker: Scott Collins
Tuesday, June 11 2024
Presentation: 7:00pm
Location: Webinar (zoom link sent via email to members)
UDI: FDA vs. EU Topic
In 2013 the FDA passed its UDI directive for the identification of medical devices. The European Union (EU) Commission followed suit in 2017 with a rewriting of the Medical Device Directive to the new Medical Device Regulation (MDR). Both regulatory bodies applied a staged approach to enforcement of the requirements in their respective regions. The FDA UDI requirements are now in full force requiring full UDI on both the labels and reusable devices themselves. The EU MDR was fully applicable in 2021 and is currently in the middle of their UDI implementation schedule. Class III, IIb, and Class IIa devices should already have the UDI on the labels, with Class I labels following in 2025. The UDI should already be marked on reusable Class III devices with reusable Class IIa and Class IIb following in 2025, and reusable Class I devices in 2027. What are the differences between the FDA UDI requirements and the EU UDI requirements? Let’s take a minute to review
Scott Collins is a Principal Validation Consultant at QPharma, Inc. He has over 36 years’ experience in the pharmaceutical and medical device industries in the areas of Validation, Quality Control, Quality Assurance, Auditing, Manufacturing and Project Management. Scott has been involved with remediation efforts associated with 483s, Warning Letters and Consent Decrees, being responsible for the management of the projects and their deliverables. He has validated and been responsible for validating computer systems, laboratory instruments, and manufacturing equipment and systems. He has also helped clients develop or rework their Quality Management Systems.
Look out for upcoming event
Job opening |
NYC Tech company seeking tech. or recent grad. to grow with this medical device company.
Looking for motivated, self-starter individual willing to be involved with manufacturing, engineering and quality. Someone with the ability to generate appropriate documentation for medical device products. Dynamic cutting-edge culture with ability to grow and expand with the company. The opportunities are endless for the right candidate. Contact Emil Muccin at 914-582-6919 or [email protected]
Looking for motivated, self-starter individual willing to be involved with manufacturing, engineering and quality. Someone with the ability to generate appropriate documentation for medical device products. Dynamic cutting-edge culture with ability to grow and expand with the company. The opportunities are endless for the right candidate. Contact Emil Muccin at 914-582-6919 or [email protected]