Educational seminars on all aspects of product development for medical devices with electronics hardware and software
All webinars include 30 to 40 mins of presentation followed by 20 to 30 minutes of questions
This presentation is a high-level overview of the product development process for active medical devices. We explain how active devices are different from inert MedTech, the range of service providers needed to bring your product to life and the complex web of quality systems, regulatory processes and product certification. This webinar is aimed at people considering developing a medical device and service providers wanting to understand the big picture outside of their field.
12 Jan 2020 - Regulatory requirements for Active Medical Devices
This 40-minute presentation explores the compliance and certification requirements for creating and marketing active medical devices. The two main regulatory regimes around the world are examined. The critical role of the technical file and how it applies to different regulatory processes is explained. The role of harmonized standards and quality systems in the regulatory compliance process is also explored. The webinar is presented by a senior consultant at Brandwood CKC, a leading regulatory consultant for medical devices.