Introduction to Medical Devices in the USA
Online Training Id: PCGMD1
Geographical Region: International
Duration: 1 hr 30 mins
An overview of the current medical device requirements expected by the FDA to achieve a marketing authorisation
To understand how current regulations have evolved
To understand the classification system or know where to find information to aid the classification of devices
To understand requirements of device development and routes available to obtain market approval in USA i.e. 510k and PMA
To review the information required to support an application eg biocompatibility data as defined in ISO series 10993
To gain an overview of clinical investigations of Medical Devices for Humans and the information needed for approval of an Investigational Device exemption for class III device clinical trials
To gain an overview of Medical Device Quality Management Systems and the Risk Management System
To review the current Unique Device Identification requirements
Registering your product with FDA
Understanding the need for post marketing surveillance
Who Should Enroll:
Novice medical device scientists entering the medical device industry
Experienced personnel switching sectors or roles
Professor Luigi G Martini, BSc (Hons), PhD, FRPharmS, MBA is the UK’s first and only Industrial Pharmacist teaching practitioner as Professor of Pharmaceutical Innovation at King’s College London. He is also co-Director of Rainbow Medical Engineering Ltd, a specialist ultrasonic welding and medical device Fabrication Company. Expert in drug delivery systems, medical device engineering, and personalised medicine; he consults for global companies and regulatory agencies in Europe and the Middle East. He participated in the European Parliament debates and was appointed to the REF2014 sub-panel for Pharmacy, Dentistry, Nursing and Allied Healthcare professionals in 2011.
While at GlaxoSmithKline Pharmaceuticals, he was Senior Director of Pharmaceutical Development for Emerging Markets responsible for developing affordable medicines for the BRIC economies. He developed and commercialised the DiffCORE technology launched in the USA as Lamictal XR, and was instrumental in embedding Quality by Design principles in GSK’s main development and manufacturing sites.
He was a founder of the European Industrial Pharmacy Group and was president of the organization for 10 years. Professor Martini was a Visiting Pharmacy Professor at John Moores University of Liverpool (2006-2011) and designated a Fellow of the Royal Pharmaceutical Society in 2008.
Prof. Luigi Martini
PHARMACEUTICAL INNOVATION, KINGS COLLEGE LONDON