Speakers & Chairman
MedBraid 2021: A gathering of industry experts, founders and executives.
Speaker
Jonathan Lintott
[LinkedIn]
Starting as a sterilization engineer in Asia almost 30 years ago Jonathan Lintott has developed to become one of the leading figures in the European Sterilisation Industry. He has a combination of operational, research and regulatory experience and has been a member of the AAMI Sterilisation Working Group in the USA and the ABHI Sterilisation Group in the UK.
As the CEO of Andersen Caledonia, Jonathan Lintott runs the largest independent contract sterilisation company in the UK and one of the largest contract suppliers of ready to use pharmaceutical vials in Europe.
His expertise includes ethylene oxide and steam sterilization, sterile barrier packaging and device testing. He has written several papers on these subjects and recently authored an article on the removal of DNA using an extended ethylene oxide cycle.
Mr Lintott is a regular presenter across the globe and has spoken in Europe, Middle East, Asia and the USA. He enjoys teaching and in the last few years has taken on the role of visiting tutor at the University of Limerick teaching sterilization and equipment qualification to the masters students.
Speaker
Michael Maier
[LinkedIn]
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.
Speaker
Yacine Gérard
[LinkedIn]
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.
Speaker
Gilles Farron
[LinkedIn]
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.
Speaker
Dr. Linda Ahnen
Dr. Linda Ahnen is a physicist by training. She specialized in biomedical engineering during her Diploma and PhD studies. Her doctorate at the ETH Zurich was carried out in close cooperation with the University Hospital Zurich, developing a novel near-infrared imaging device to image oxygenation in the brain of preterm infants. Besides managing the Olten team, Linda is specialized in working in and managing interdisciplinary projects, she actively collaborates with experts from different fields and possesses proven scientific writing skills. Linda supports you in clinical evaluations, clinical investigations, technical documentation, regulatory strategies and implementation of quality management systems.
Chairman
Laurent Grandidier
Laurent Grandidier is a veteran in innovative cardiovascular devices and brings a solid track record of successfully building and leading diverse, cross functional teams for both start-ups and Fortune 500 companies, including Xeltis, Endosense, Boston Scientific, Guidant, and Procter and Gamble. Laurent holds several independent board positions and has received numerous professional awards including the 2018 Outstanding Executive at the Global Business Excellence Awards and the Best European CEO in Medical Devices by European CEO Magazine in 2015. He holds a Master of Science in Computer Science from the National Institute for Applied Sciences in Lyon, France, and an MBA from INSEAD, France-Singapore.