1 Hour and 20 Minute Video | Jayanth Katta, BSI
The recently issued EU Commission Regulation 207/2012 on electronic Instructions for Use (IFU) in medical devices, effective March 1, 2013, is applicable to devices covered by the AIMD (90/385/EC) and the MDD (42/93/EC). The regulation is heavily geared towards manufacturers performing and documenting additional risk assessments which take into account the volatility of technology. In today’s stringent regulatory environment where medical device manufacturers are often required to demonstrate traceability throughout the product lifecycle, accurate labeling is critical.
- Outlining scope of applicable device and accessory types
- 90/385/EEC (AIMDD), 93/42/EEC (MDD)
- EIFU regulatory requirements
- Risk assessments
- Website requirements
- EIFUs benefits and challenges for manufacturers and users
Participants that will find this webinar most beneficial will be those involved in medical device and diagnostic companies. Job titles of attendees that will be most applicable for this session will be:
- Regulatory Affairs
- Labeling Compliance
Jayanth Katta PhD
Product Specialist & Certification Manager, Medical Devices
Jayanth Katta PhD, Product Specialist & Certification Manager, Medical Devices, BSI
Dr Jayanth Katta has been working as a Certification Manager & Product Specialist in the Medical Devices division of BSI since July 2010. His area of focus has been soft tissue implants. Prior to joining BSI, he was the Chief Scientist at a start-up medical device company based in Philadelphia, USA working on developing materials and devices for connective tissue repair. He holds a PhD in Bioengineering from the University of Leeds, UK.