Extractables and Leachables for Medical Devices Q&A. On Demand.

In case you missed it here is a recording of our live Q&A session focused on chemical characterisation and biocompatibility for medical devices.

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Covering topics such as:

  • Chemical Characterisation- following ISO 10993-18 (2020)
  • Biocompatibility Requirements
  • Considerations around ISO 18562
  • General medical device regulations

Speakers

Lina Burman. Limulus Bio AB/In.

Lina has a PhD in Polymer Technology with focus on evaluation of migration and degradation behavior of polymeric materials. 13 years of experience within the medical device industry, working mainly with biological evaluations and toxicological assessment, of which 10 years with focus on breathing gas pathway related devices. Performed evaluations of class I – class III devices, mainly the EU and US markets.  In addition, experience within clinical evaluations, environment related requirements, failure evaluations, and chemical characterization. Member of the Swedish International Standard Institute (SIS), ISO/TC 194 committee since 2006, working with the ISO 10993 standard series as well as active in the work with the ISO 18562 standard series for biological evaluations of breathing gas pathways.

Philip Clay. Chorley Consulting.

Philip Clay is Director and principal toxicologist with Chorley Consulting. He is a UK and European registered toxicologist and specialises in safety assessment with over 30 years experience. He has published and presented widely in his expert field of genetic toxicology and also in the wider area of safety assessment. Chorley Consulting designs safety assessment programmes for medical devices and also provides toxicological advice for a range of product types. Philip is presently a BSI committee member for CH/194 (Biological evaluation of medical devices).

Kathleen Krenzer. iuvo BioScience.

Dr. Krenzer is currently a Research Fellow and board-certified Toxicologist at iuvo BioScience where she oversees and provides consulting and strategic support for medical device and pharmaceutical programs.  Dr. Krenzer is also responsible for bringing on new capabilities and model development. Additionally, Kathleen is an adjunct professor at the New England College of Optometry, teaching in their international optometric programs.

Andrew Feilden. Hall Analytical.

Dr Andrew Feilden is the European E&L Strategic Director at
Hall Analytical. He joined Hall in November 2019 where he is a technical expert in the field of E&L testing undertaking commercial, operational and technical thought leadership activities. He has presented on the field of extractables and leachables in over 16 countries world wide. Andrew has written a number of papers and publications and is the inventor of 2 patents. He has a degree and D Phil from the University of York, is a Fellow of the Royal Society of Chemistry and was a Scientific advisor to IPAC-RS and ex-cochair of ELSIE.

Moderator

Nick Morley. Hall Analytical.

Nick has over 12 years of experience in the field of extractables and leachables, both in large pharma and at a CRO. He is responsible for providing technical/consultative support to new and existing customers in the field of E&L. Experience working on a range of products including pharmaceutical/biopharmaceutical (inhalation, topical and parenteral), medical device and nicotine delivery systems.

Nick has a BSc in Chemistry, is a BSI Committee member and British representative on the CEN (European standards Committee) working group for extractables and leachables of Electronic Cigarettes & E-liquids.