MDR and IVDR (EU Medical Device and In-Vitro Diagnostic Device Regulation)

Date: March 19, 2020

Location: TBD

Dinner Meeting Agenda:

6:00-6:30 PM – Pre-dinner Topic: AS9100D Changes in the Latest Revision by Jay Patel

6:30-7:15 PM – Dinner

7:15-7:30 PM – Section Business

7:30-8:30 PM – Dinner Presentation

 

Pre-Dinner Presentation: AS9100D Changes in the Latest Revision by Jay Patel

The AS9100D standard includes ISO 9001:20152 quality management system requirements and specifies additional aviation, space, and defense industry requirements, definitions, and notes.

It is emphasized that the requirements specified in this standard are complementary (not alternative) to customer and applicable statutory and regulatory requirements. If there is a conflict between the requirements of this standard and customer or applicable statutory or regulatory requirements, the latter shall take precedence.

Jay Patel will explain the key changes in Rev D.

 

Main Dinner Presentation:

The EU has completely overhauled their regulatory system. If you plan on selling medical devices in the EU, the bar has been raised. You can no longer enter the market under the previous directives; they have all been transitioned to an ‘FDA-styled’ regulation-based system with restrictions on enforcement by member countries.

This is having a major impact on the whole industry with several smaller companies and notified bodies going out of business and huge bottlenecks in getting new products to market.

Learn the key aspects about this new system in this 1-hour session that includes the key changes in the EU Medical Device and In-Vitro Diagnostic Regulations, with a focus on the new classification scheme, post-market surveillance, technical file expectations, and the EU Universal Device Identification. We will also discuss how to quickly create a master plan and implement it most efficiently in practice to go through the new regulatory labyrinth in the workplace, so as to minimize any disruption due to this new regulatory process.

 

Presenter: Raj Kasbekar, ASQ CQE, CBA, CQM & OE, Green Belt, Regulatory Affairs Certified US, Vice President of Regulatory and Clinical Affairs

Raj Kasbekar is Global Vice President of Regulatory, Quality Systems, and Clinical Affairs at Kaz USA, Inc., a Helen of Troy Company. Helen of Troy is a 1.6 billion-dollar company with leading brands such as Vicks, Braun, Honeywell, Revlon, Dr. Scholl’s etc., and products that are sold globally.

Raj has more than 20 years of experience in management, regulatory affairs, clinical affairs, quality systems, program management, and product quality, and has held wide-ranging positions including RA/QA Leader at GE Healthcare, RA/QA manager at Hologic, besides consulting assignments at many reputed Fortune 100 companies.

Raj has four ASQ certifications, including Certified Six Sigma Green Belt. He has an extensive medical device background and has been instrumental in commercializing several products, implementing Quality systems at startup and large companies, and handling over 20 FDA and ISO audits. He has Bachelor and Master Degrees in Engineering and an MBA. He has also published several peer reviewed articles and white papers, and has patents pending.