Well 2022 really did start at full speed with us all working towards tight deadlines on a range of projects. And as we mentioned before in our last article, we are so pleased that EpiGuard received their ISO 13485 certification. Malsen Medical led the development of all their QMS processes, tools, internal training as well as the certification audit process. This is another great example that the Malsen Medical “lean QMS” is compliant to ISO 13485 and we are proud to have been able to implement this successfully at EpiGuard!

Our development model for new medical devices and in-vitro diagnostic products drives projects through 4 milestones – from concept at milestone 1 through to global launch at milestone 4 – with defined deliverables at each gate. In all our development projects, we ensure common goals with the client and drive products to market. This next few weeks we are working towards milestones 2 and 3 for several of our our major projects.

This month, we won new projects in France (pharma IT development and validation) and Norway (class II medical device project execution). Our pipeline of upcoming projects is looking promising too.

In January, we also welcomed the following new consultants to the Malsen team:

– Senior QMS/QA (France)
– Senior Commercial Consultant (Germany)
– Usability Engineer (UK)

We continue to build our team across Europe to ensure we deliver best in class services to our growing customer base.

To further accelerate our growth and build the organization, Malsen Medical has joined a business accelerator program in Frankfurt, Germany. We want to deliver best in class services to our customers, and at the same time,  ensure that our own organization matures and is fully prepared for the next steps.