Introduction to Medical Devices in the USA

Online Training Id: PCGMD1

Geographical Region: International

Level: Basic

Duration: 1 hr 30 mins

[Watch a Demo]

An overview of the current medical device requirements expected by the FDA to achieve a marketing authorisation

Learning Objectives:

  • 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  


GBP $75.00