Key guidance on how to use the ISO 10993 series of standards and successfully apply a risk management approach to the biological evaluation of medical devices.
9-10 Apr 2019
& 2-3 Oct 2019
GBP 1,499 1,299 *
EUR 2,099 1,819 *
USD 2,338 2,026 *
* When you book before 15 Feb
New for 2019
The ISO 10993 series of standards covering biological evaluation of medical devices is well established and regulatory authorities worldwide expect compliance. In Europe compliance with the standards will be the easiest way to meet the relevant essential product safety requirements of the Medical Device Regulation. Understanding a risk management approach to biological evaluation is essential.
This seminar will provide key guidance on how to use the standards and successfully apply a risk management approach to the biological evaluation of medical devices. There will be plenty of time for interactive discussion with experts in this field.
This seminar will be of importance to those in the medical device industry from the following departments:
General principles of biological risk management
Interactive session: Hazardous situations
Reviewing existing data
Interactive session: Evaluating chemical data
Quantitative toxicological risk assessment (QTRA)
Interactive session: Gap analysis
Risk assessment and control
Interactive session: Risk reduction
Interactive session: Risk review
Q & A discussion
Summary and conclusions
Jeremy Tinkler (9-10 Apr 2019)
Jeremy Tinkler, Director, Regulatory Consultancy & QA, MedPass International. His responsibilities include; regulatory & clinical strategy, adverse event assessment & reporting, regulatory consultancy (strategic planning, clinical evaluation, biocompatibility assessment, risk analysis, etc.). He is a member of the European Commission Working Group on Clinical Investigation & Evaluation and has overall management of ISO 13485 QMS.
From 1987-2007, he was with the MHRA (UK Competent Authority) as Principal Specialist, Biosciences & Implants. His responsibilities there included direction of safety assessments, e.g.clinical investigation notifications and adverse incident investigation. He is also experienced in the following areas: tissue engineering, emerging technologies, drug-device combinations, animal tissues, wound care/closure products, cardiovascular, plastic surgery, ophthalmic, orthopaedic implants, biocompatibility, risk management, compliance assessment, quality/NB audit, product evaluation, research commissioning and borderline classification.
He takes a leading role in standards development, at national and international level and is Chairman of ISO/TC 194 (which develops ISO 10993 & 14155). He is also a European Registered Toxicologist. He has 10 years experience as a toxicologist, Study Director or Senior Scientist in toxicology laboratories and the Health and Safety Executive. Jeremy managed MHRA’s device toxicology activities 1987-2007 and he is a Lecturer at the University of Surrey and Queen Mary, MSc.
Michelle Kelly (9-10 Apr 2019)
Michelle Kelly is Biological Safety Manager for MHRA devices. She has worked for the agency since 2008 and current responsibilities include principal lead on all clinical trial applications for biological safety, provide expert biological safety advice and direction to the regulatory and safety and surveillance teams on compliance, vigilance and Notified Body matters. Michelle also works with key stakeholders towards the development of international standards to help innovation to the UK market. She is currently the chair of CH/194, a committee responsible for the UK input to ISO/TC 194 and CEN/TC 206 for standards relating to biological evaluation of medical devices. Michelle has a BSc in Biomedical and Advanced Materials from University of Limerick in Ireland, and an MSc in Applied Toxicology from University of Surrey achieving the top mark in both programmes of study.