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 on-demand 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, you will – at least in theory – know what to do and what to avoid in order to get hassle-free through biocompatibility assessments.
Dr. 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.
Watch the entire ISO 10993 webinar series here.