Webinar: How to bring your device to the market – Technical documentations, practical tips
Friday, 13 December 2019, 12pm to 1.30pm
Organised by: Oxford Medical CE Marking Forum (Regent Lee, Jeroen Bergmann, Rita Hendricusdottir)
Free registration via eventbrite: https://oxmcefdec2019.eventbrite.co.uk
Speaker: Dr Azad Hussain
Are you developing a medical device? Would you like to bring your device to the market? Then you need to compile Technical documentation. The earlier you start working on your Technical documentation the easier it will be to conform to the Medical Device Regulation when you plan to bring your device to the market.
In this webinar we will discuss:
Information supplied by the manufacture
Design and manufacturing information
General safety and performance requirements
Product verification and validation
Benefit-risk analysis and risk management
About the speaker
Dr Azad Hussain is an experienced engineering professional with over nine years of industrial and academic research experience. He completed his PhD studies in 2004 at Queen Mary College, University of London, in the field of biomechanics, biomaterials and tribology. Upon his PhD completion, Azad worked as a research scientist on an interdisciplinary and collaborative project with industry, focused on the research, testing and analysis of implants using new materials and designs.
In 2006, Azad held a R&D engineering role at Smith and Nephew Orthopaedics. He gained valuable experience in the areas of laboratory set-up, NPI (New Product Introduction) and managing a UKAS (UK’s National Accreditation Body) accredited QMS, the first of its kind in the field of orthopaedic bioengineering. Following a career break, Azad returned to work with the Functional Materials Group at Coventry University, where he worked on various projects in electronics and automotive industry.
Azad’s expertise includes Medical Device Regulations, manufacturing methods and process improvement, with previous applied experience in setting up QMS (ISO 17025, working in ISO 13485 compliant manufacturing site and class III medical devices). Currently working at the Medical Device –Testing & Evaluation Centre, the Institute of Translational Medicine, University of Birmingham.
Further instructions on how to join the Zoom webinar will be made available to you after registration of the event.