Join our webinar , which provides legal manufacturers of SaMD with an overall update on the Medical Device and Notified Body Industry and the Medical Device Regulation.
Software in medical devices represents a rapidly expanding area of health care. The role of digital platforms continues to evolve and is increasingly playing a vital role in all areas of patient health, from diagnosis to treatment to monitoring.
As an integral part of medical devices, software may be used to manufacture or maintain a device. Software itself can even be a medical device. In all cases, the software needs to meet certain requirements and comply with regulations. Thus, it is important to determine which rules apply.
Objective
The objective of this webinar is to provide legal device manufacturers of software as a medical device (SaMD) with an overall update on the Medical Device and Notified Body Industry and the Medical Device Reulation (MDR).
Agenda
- Introduction
- Information on SaMD technical documentation review
- UKCA/MDD, code MD1111
- Status of MDR, code MD1009, under Rule 11
- How we can support you and your contract manufacturers
- Q&A
Speakers
- Balázs Bozsik – Technical Director - MDD/MDR, SGS
- Greg Jacobson – Sales Director - Medical Devices, SGS
Can't make a live session?
Register now and receive a complimentary recording after the live event.
For further information, please contact:
Michelle Lee
Marketing Specialist
t: +1 201 508 3065