Our Chairman & Speakers
Our Chairman - Jonathan Lintott
Jonathan Lintott is the managing director and co-founder of Andersen Caledonia the largest independent sterilisation company in the UK and Ireland. After earning a degree in engineering at Oxford University and an MBA at INSEAD in France, Mr Lintott started in the industry as a young validation engineer in Asia installing gas sterilisers. After a spell in the U.S.A and then in Europe working for a steriliser manufacturer, he took over as managing director of Andersen Caledonia 15 years ago.
Jonathan has significant regulatory expertise and has participated as a member of AAMI (USA) and ABHI (UK) sterilisation working groups. He is also a keen speaker on sterilisation subjects and is a visiting lecturer at the University of Limerick in Ireland.
Mr Lintott has considerable knowledge on validation of steam and gas sterilisers but has additionally run two microbiological laboratories and a contract cleanroom manufacturing medical devices. With over 30 years of hands on experience on the sterilisation of over 100 different device families.
“Biocompatibility: Understanding the new ISO 10993”
Sandra Klompmaker - Senior Associate at Medidee
Dr. Sandra Klompmaker is an RA/QA and clinical investigations-oriented life scientist with more than 10 years of experience in in vivo and in vitro experimental design, implementation and data analysis. Dr. Klompmaker has earned her doctorate in molecular and cellular biology from the university of Groningen. Her educational background is in biotechnology, biology and medical laboratory research.
Sandra's activities in the field of RA/QA and clinical affairs cover Clinical Evaluations, the deployment of quality management systems and facilitation of the submission of technical documentation for CE marking of medical devices. Other key competencies are biological evaluation and biocompatibility assessment of medical devices.
“Ethylene Oxide Sterilisation: The sustainable development & validation of effective processes”
Yacine Gérard - Quality Manager at Medistri S.A
Yacine Gérard is responsible for the management of the Validation and Quality Assurance Department at Medistri SA, a Swiss company specialised in sterilisation processes and laboratory. Yacine graduated in Human Science (law, management, statistics) and completed his training with a CAS in Management of Technology at HEC and EPFL with a specialisation in Medical Devices. He was also trained as an internal auditor. Shortly after the release of ISO 11135-1 in 2007, he has been in charge of the sterilisation validation processes and has handled more than a hundred of validation projects covering many different product families such as: implants, catheters, pharmaceuticals syringes, orthopaedic devices, sterile kits and ophthalmology devices. All these projects have given Yacine a broad experience with Regulatory Requirements and Frequently Asked Questions. He was notably leading the transitioning process into ISO 11135:2014.
Today, he keeps an overview of all the activities related to process validation and routine release as he is responsible for the approval of all validation reports and handling of external audits (such as FDA, Notified Body and customers). He is also a consultant and trainer for external companies and acts as a product reviewer in validation and routine ETO sterilisation processes.
“Complying with the European Union’s MDR”
Michael Maier - Senior Partner at Medidee
Mr. Michael Maier is co-founder and Senior Partner of Medidee Services SA, a Switzerland based Medical Device Consultancy with a global scope committed to strategic and operational Regulatory Affairs consulting since 2002. He started his career in 1996 as a medical engineer in the field of gas dosing devices for ICU ventilators and anaesthesia workplaces and managed design . Michael Maier has now over 20 years of hands on experience within the medical device industry. More specifically in design & development projects, product industrialisation and regulatory & quality affairs. Michael is a trained Notified Body auditor for ISO 13485 and MDD with a broad scope of products.
He has worked for the several notified bodies and has covered international compliance programs such as CMDCAS, J-PAL, TCP, TGA. Michael combines sound technological knowledge with global regulatory expertise with medical devices. He is a regular speaker at international events for medical devices, quality and regulatory affairs. Mr. Maier contributes often in seminars and training programs for Medidee, Medbraid, Medtech, MEGRA and RAPS.
“Sterile Packaging of Medical Devices – Impact of MDR”
Trixi Hollweck - Senior Product Specialist at TÜV Süd
Dr. Trixi Hollweck is an expert in Ethylene Oxide (EO) Sterilisation and owns the technical responsibility for Medical Packaging within TÜV Süd Product Service GmbH as Senior Product Specialist. She assesses the EO-Sterilisation and Packaging validation documentation submitted in Design Dossiers/Technical Documentations of Medical Devices.
Dr. Hollweck also audits the Quality Management System of Medical Device Manufacturer according to EU Medical Device Directives and Regulations as well as EN ISO 13485.
“Medical device cleanliness. Compliance to MDR 2017/745: impact of biological and chemical testing. An overview.”
Gilles Farron - Biologist and Laboratory Manager at Medistri S.A
Gilles Farron is a Biologist that has more than 10 years of experience working in the management of testing laboratories conducting microbiological, chemical, biological and physical analysis’s of pharmaceutical, environmental and medical devices. His fields of expertise are biological evaluations of medical devices, cleaning validations, reprocessing controls and testing validation methods (such as EP, USP, ISO, ICH, ASTM). Gilles Farron has gained strong practical expertise as a service provider for a number of multinational companies and startups. With them he has validated a wide range of devices throughout their intended uses, markets, regulatory requirements, material properties and manufacturing processes.
Gille Farron earned extensive regulatory experience and understanding through his role as an expert in biological/toxicological evolution of medical devices for different market conformities.
“Additive Manufacturing (3D Printing) Microbiological Considerations for DePuy Synthes Resorbable Polymeric Patient Specific Implant”
Dawn Nestlea - Manager Microbiological Quality & Sterility Assurance at DePuy Synthes
Dawn joined DePuy Synthes in 2013 as a Senior Scientist and currently leads a Microbiological Quality & Sterility Assurance team responsible for the support of New Product Development and Lifecycle Management projects. She and her team provide expertise in the areas of sterilization, aseptic processing, clinical reprocessing and contamination control of manufacturing environments for external suppliers. She has been with Johnson & Johnson for 13 years.
Dawn’s 19-year career as a microbiologist includes experience in Medical Device, Pharmaceutical, Biotechnology and Consumer Healthcare. Her primary technical roles have been focused on terminal sterilization and aseptic processing. She has also served as an adjunct professor teaching a college level course on the fundamentals of aseptic processing.
Dawn earned a Bachelor of Science degree in Microbiology from Michigan State University (East Lansing, Michigan) and holds a Master of Business Administration degree from Centenary University (Parsippany, New Jersey).
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