
How to bring your device to the market - Technical documentations, practic...
Event Information
Description
Organised by: Oxford Medical CE Marking Forum
Date: 13 Dec 2019
Time: 12:00 UK time / 13:00 Europe
Webinar: How to bring your device to the market – Technical documentations, practical tips.
Speakers: 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:
Device description
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.
Joining instructions:
Further instructions on how to join the Zoom webinar will be made available to you after registration of the event.
Privacy Policy:
Eventbrite processes data (including any personal data you may submit by booking this event) outside of the European Economic Area. Please only submit any personal data which you are happy to have processed in this way, and in accordance with Eventbrite’s privacy policy applicable to respondents. If you prefer not to use Eventbrite for responding to this invitation, you may respond directly to regent.lee@nds.ox.ac.uk, jeroen.bergmann@eng.ox.ac.uk, or rita.hendricusdottir@eng.ox.ac.uk
Join our LinkedIn group for updates on future events.
Click on the icon to sign up to the Oxford Medical CE Marking Forum mailing list
FAQs
Are there limits on the number of attendants?
Yes, there is a limit of 100 registrations on the first in first served basis.
How do I get the joining instructions for the Webinar?
After you register for the event, a confirmation email will be sent to you. Please scroll down to the bottom of this email to get the joining instructions.
How can I contact the organizer with any questions?
email the organisers:
regent.lee@nds.ox.ac.uk jeroen.bergmann@eng.ox.ac.uk rita.hendricusdottir@eng.ox.ac.uk