ISO 10993 Webinar Series: Importance of Biological Evaluation Plan & Common Biocompatibility Pitfalls (Part 7 of 7) Session 2

Webinar

Webinar

LEARN ABOUT THE IMPORTANCE OF BIOLOGICAL EVALUATION PLAN & COMMON BIOCOMPATIBILITY PITFALLS (SESSION 2)

The requirements during the assessment of the biocompatibility of a medical device increased within the last years, especially with the release of the ISO 10993-1:2018. The prescient planning on this is the key for a successful certification.

This webinar will show you the concept and strategies for Biological Evaluation Plans (BEP) as well as common pitfalls during the assessment of the biocompatibility. After this webinar you will – at least in theory – know what to do and what to avoid in order to get hassle-free through biocompatibility assessments.

Date: 31 March 2022, Thursday

Time: 3:00 PM CEST/ 6:30 PM IST/ 9:00 AM EDT (Session 2)

Duration: 1h (including 15 mins for Q&A)


KEY TOPICS COVERED:

  • Introduction
  • Biological Evaluation Plan (BEP): basis, structure & content, importance
  • Common pitfalls in the biocompatibility evaluation
  • Q & A

ABOUT THE SPEAKERS

Dr Shailendra SinghDr. Shailendra Singh

General Manager & Head of TÜV SÜD MHS-South Asia

Dr. Shailendra Singh is Doctorate in Biochemistry. He investigated various aspects of cellular biochemistry during his doctoral research. He has been leading the Medical & Health Services (MHS) Business Unit of TÜV SÜD South Asia since 2019. Dr. Shailendra has many years of experience in Pharmaceuticals and Medical Device Testing Labs in India and Europe and held several positions leading genotoxicity, in vitro safety assessment and Quality Assurance teams.

He is an expert of Biocompatibility with a strong knowledge in General Toxicology, genotoxicity and in vitro alternative methods and having extensive experience in Risk Assessment and Biological Safety Evaluation. Within TÜV SÜD, he is responsible for divisional operations of MHS business unit of South Asia, as well as testing business of South Asia, Africa and Middle East.

 

 

 

Dr. Christoph D. Lindner

Team leader for Medical Device Testing of TÜV SÜD Product Service

Dr Christoph D. Lindner holds a Ph.D. in Organic Chemistry which followed studies on Chemistry and Biochemistry.

After working for a medical device manufacturer in ophthalmology as head of R&D, he took over the position as a team leader in a laboratory for medical device testing. Subsequently he joined TÜV SÜD (Munich) in 2018 as lead-auditor for ISO 13485/MDD/MDR and is currently the team leader for medical device testing.

His focus is on biocompatibility and chemical characterization but also on transport simulation and packaging validation.


IS0 10993 WEBINAR SERIES

 

Watch the entire ISO 10993 webinar series here.

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