Together with our cooperation partner Swedish Medtech we would like to discuss about MDSAP program and audits and about Usability Engineering of a Medical Device and the role of UX in it. Thus, we've been invited to hold two online events with Swedish Medtech to share our ideas and experiences. You're all warmly welcomed to join!
WEBINAR INFORMATION #1. | MDSAP program and audits - an overview and experiences:
Do you wish to sell your medical devices in Canada? Do you want to reduce your regulatory burden and have fever annual audits? Then Medical Device Single Audit Program (MDSAP) might be just the thing for you.
Through the MDSAP program and MDSAP certificate, companies are able to prove they are compliant with ISO 13485:2016 standard, but also indicate they fulfill the additional regulatory requirements set by the countries participating in MDSAP program (Australia, Brazil, Canada, Japan and USA). This means that you can access multiple markets with a single audit. In Europe, you will need to meet the requirements of the Medical Device Directive (MDD) or the new European Medical Device Regulation (MDR), but if you also intend to export to Canada, then also MDSAP is mandatory.
In this webinar, we will share an overview of the MDSAP program, and provide some practical experiences and tips related to MDSAP audits from manufacturers point of view. Are you unsure what is MDSAP program in practice and what to expect from an MDSAP audits? Join us to learn more!
- WHEN & WHERE: 16th November at 10:00-11:00 (Swedish time) as online event
- REGISTRATIONS: This webinar is open and free for anyone to attend! The original webinar promotion can be found from Swedish Medtech's website and the registration can be made through their page as well.
WEBINAR INFORMATION #2. |Usability Engineering of a Medical Device and the role of UX in it:
Are you selling or building your medical device using false usability arguments? Did you think that user experience (UX) is the quality that should be highlighted?
Usability of a medical device is not viewed from the same perspective as usability of a consumer device. Usability engineering of medical devices is a regulated domain and implemented according to specified process requirements. Although conventional usability attributes such as effectiveness, efficiency and user satisfaction are applicable, the focus is on risk management.
Join the event to hear about usability engineering required for design and development of a medical device and how user experience relates to it!
- WHEN & WHERE: 8th December at 10:00-11:00 (Swedish time) as online event
- REGISTRATIONS: This webinar is open and free for anyone to attend! The original webinar promotion can be found from Swedish Medtech's website and the registration can be made through their page as well.
