There are significant changes in the EU regulations regarding several areas within the medical device regulatory framework. QAdvis, as an active member of the European Association of Authorised Representatives can give you current knowhow as well as the future perspective.
Software as a Medical Device
Regulatory and Market Access Implications
QAdvis Principal consultant Robert Ginsberg and Mikael Dahlke are two of the co-authors!
Software as a medical device (SaMD) is a relatively new phenomenon. It can be challenging to regulate it and there is relatively little guidance available. The book Software as a Medical Device, Regulatory and Market Access Implications offers this guidance in several key areas. This book will help you to understand the implications of developing and selling SaMD, including the mistakes and pitfalls to avoid. QAdvis has contributed to the chapter about software risk management, and how to make it work well for you.
Don´t miss out on the upcoming webinar, Medical device software regulations in the EU on June 3rd.
Three of QAdvis Principal consultants will be presenters, Cecilia Emanuelsson, Robert Ginsberg and Mikael Dahlke.
The common denominator for all medical devices, independent of if it includes software, has sterile parts, is an active device, or maybe is an Annex XVI listed device, is that all medical devices need to fulfill the requirements in MDR by the end of May 2021.
MDR is challenging for all types of devices and economic operators, and it is important to understand how the requirements impact your organization and your devices.
For MDR class I manufacturers, the deadline for implementing all requirements in the regulation is May 26th, 2021. To learn more about the timeline and important aspects for class I manufacturers QAdvis have developed a course together with Swedish Medtech, read more here >>>.
If you have any questions about our newsletter, please feel free to contact Hermine Redl, Office Manager, by phone on +46 8 621 01 05 or email here.
What is your area of expertise within the Medical Device industry?
It is primarily medical device software. I have worked with QMS, QA, risk management and technical documentation of software devices, especially with conformance to ISO 13485, IEC 62304, and IEC 60601-1 amongst others.
What is your best quality in your work as a consultant?
I am good at understanding different perspectives, such as those of regulators, users, product owners or developers. I believe this helps in finding the right balance between what to do and how much to do.
If you can only pick ONE piece of advice to give to your client, based on your expertise, what would it be?
Regulations are in place to ensure safe devices are placed on the market, understanding the need for various requirements can go a long way in achieving the desired level of conformance.
Where do you find recovery in your everyday life?
I am a huge sports fan and watching some sport helps me relax and unwind, for the most part!