Fit for MDR (Part 1 of 4): Biocompatibility

DAY & DATE: Monday, 9th November 2020

TIME: 11.00 am IST | 1.30 pm SGT | 12.30 pm ICT

AGENDA:

Our expert will provide an end-to-end overview on the following topics:

What is new under MDR / ISO 10993-1:2018
NB checklist for the assessment of biocompatibility
Required documentation / information
Common non-conformities
Technical exchange possibilities

WHO SHOULD ATTEND:

All QA & Regulatory Personnel of Medical Device Manufacturers

MEET THE SPEAKER:

Mr. Senthil Kumar A, a Master of Philosophy degree-holder in Biochemistry is an experienced toxicologist, presently working as an Auditor and Biocompatibility expert in Medical and Health Services (MHS), TÜV SÜD Products Services Division.

Mr. Senthil has been responsible for reviewing the biocompatibility assessment and toxicological risk assessments across TÜV SÜD South Asia, and has gained good knowledge in Pharmacology and Toxicology through his professional experience in various organizations as a researcher and study director in various in vivo efficacy and toxicological studies.

His experience in the field of Non-clinical overview, Toxicological profile, CTD, Toxicological / safety assessment for cosmetics and OTC products has helped him build a strong knowledge base in Biocompatibility Assessment of medical devices.

HOW CAN TÜV SÜD HELP YOU:

TÜV SÜD Product Service is among the world's first certification bodies to receive designation as a Notified Body for the new Medical Device Regulation by the Central Authority of the Länder for Health Protection with regard to Medicinal Products and Medical Devices (ZLG).

As a world leader, we have worked with medical device manufacturers across the world to assess the safety and quality of their devices. Our extensive experience of conducting testing on a wide range of networked medical devices, aids your compliance to regulations and access to global markets.

With more than 750 medical device professionals in more than 30 locations worldwide, we are the largest EU Notified Body globally authorised to provide certification services under the new regulation. We have MDR / MDSAP in-country authorized auditors, with Certification across classes of devices. First Class III device approved by TÜV SÜD under MDR.

For more information, please click here.

Know more and register for Part 2, 3 and 4, under our ‘Fit for MDR’ webinar series:

Part 2 - Packaging : 27th November
Part 3 - Sterilization : 7rd December
Part 4 - TD Assessment : 17th December