Season Greetings from Kalms Group
Dear Clients, Partners & Friends,
Finally we made it. 2020 is coming to an end. Even though this was a difficult year, it taught us so much about the world, the value of proper health and ourselves. We at Kalms Group are thankful for all of you. You helped make this year better.
We wish you all a cheerful holiday season and a wonderful, happy and of course healthy new year.
We hope to see you again soon (hopefully in person!) in 2021.
Read our new white paper in cooperation with NAMSA
This White Paper provides an overview and comparison of general regulatory and reimbursement frameworks for medical devices in the European Union and United States. Highlighted within are recent regulatory adjustments in key legislation and revision guidance from authorities, resultant from the quickly shifting regulatory environment within the global medical device marketplace.
While the EU and U.S. markets offer varying opportunities for medical device manufacturers, they both present challenges on the path to reimbursement and regulatory approval. Thus, early integration and planning of requirements related to market access are key factors to success for sustainable market access in these regions.
Read the full White Paper here: https://www.kalmsconsulting.com/2020/12/09/new-white-paper-achieving-eu-and-u-s-commercialization-success/
Kalms Consulting and TaylorWessing cordially invite you to the webinar
“Software as a Medical Device under the MDR”
There will be presentations on the latest trends of the following topics:
- MDSW- legal requirements, opportunities and challenges.
- Definition of the regulatory requirements
- Keynote speech: “UDI for MDSW”
- Q&A session
The event will take place on 14.01.2021 from 10:00 a.m. to 12:30 p.m. as a webinar. It is free of charge, takes place in German language and offers a platform for solution-oriented discussions.
The event is aimed at manufacturers of medical devices / in-vitro diagnostics, especially board members, executives, data protection officers, employees in Regulatory Affairs and Project Management as well as Quality Managers.
We look forward to receiving your registration here: https://app.livestorm.co/taylor-wessing-partg-mbb/software-als-medizinproduktPublished on: December 22, 2020