Presentation by Henry Sibun, a consultant in the medical devices industry and an IRCA registered lead auditor for medical device quality management systems. He has audited hundreds of medical device and pharmaceutical companies against ISO 13485 and medical devices regulations, and now supports companies in achieving certification and CE marking against these requirements.

A QMS is often seen as an additional headache with lots of paperwork that is best left until the last minute before applying for regulatory approval.  However, this is not what it should be and starting a basic QMS early in the design process can save significant time, effort and cost in getting new products onto the market.  This presentation will look at the basics of quality and quality management systems, as well as the costs and benefits, and certification to ISO 13485.  It is aimed at anyone who is involved in bringing a new medical device to market, from the first concept to applying for CE marking.

To register for a ticket to attend in person: https://www.eventbrite.co.uk/e/spark-studio-importance-of-a-quality-management-system-qms-tickets-803814399507

To register to join online: https://www.eventbrite.co.uk/e/spark-studio-importance-of-a-quality-management-system-qms-online-tickets-810105486317