Plantvision has developed the offer to help medical device companies with compliance-related processes at all stages, from innovation to an approved software. The aim is to eliminate compliance complexity, whether it is documentation, certification, application process, risk management or cybersecurity. This also allows customers to free up time and resources.
The market for Medtech is worth more than SEK 1.8 trillion in Europe alone. Sweden is at the forefront of development and has over 2000 companies active in the field.
- "For Sweden to remain at the forefront, it is important that manufacturers do not get stuck in regulatory processes," says Cecilia Fällman. The requirements are there Location for the sake of patient safety and it is crucial to be able to manage them effectively, integrated with innovation and product development. This challenge affects medical device software in particular, both products with embedded software and products where the software is the product itself.
Planvision's offering is designed to help companies effectively navigate the ever-changing requirements, risks, cybersecurity efforts and provide a clear action plan. Companies need to know which regulations and requirements to apply to their product, both today and in the future. In addition, new uses for technologies such as AI bring new ways of working that also evolve over time. According to Plantvision, expertise and strategy are essential to successfully manage the regulations and requirements while promoting innovation.
- The key is to be able to understand and weave compliance throughout the development process in a sustainable way. Today, it is unfortunately all too common that companies first develop software and then try to adapt it to the regulations, which is often both complex and can significantly delay the launch of the product," says Cecilia Fällman.
To kick off the initiative, Plantvision is offering free seminars focusing on regulations and standards for medical device software, as well as a couple of training sessions and customized workshops. The seminars are held in collaboration with BSI and Swedish Medtech, and take place as follows:
Upcoming seminars:
- Regulatory Horizon for Medical Device Software
In collaboration with Swedish Medtech, March 8 - registration on this link
- AI and Medtech
In cooperation with BSI, date and link for registration coming soon.
Training sessions:
- Software for Medtech
In cooperation with Swedish Medtech, dates: April 23 and November 19, 2024, registration via this link.
Read more and book a software workshop for Medtech at this link
For more information about seminars and training sessions, please contact
Cecilia Fällman, Chief Sales Officer
+46 8 568 59 503
cecilia.fallman@plantvision.se
For more information, please contact
Björn Dahlgren, Northern Link PR for Plantvision
bjorn@nlpr.se
