Last year we experienced broad growth across our business with successful deliveries in many projects, winning new clients and adding resources in several disciplines.
Some highlights:
- Ensured certification of a medical device class I software and built up the QMS for Diagnostica in time for the MDR cutoff.
- Secured a major research grant with Orphan Diagnostics and commenced formal development of their innovative IVD product (class C) for point of care toxicology testing.
- Set up team, including the project lead, to develop and bring to market an active medical device (class II) with Norsk Luftambulanse.
- Finalized MDR compliance for EpiGuard technical documents, built up and implemented ISO 13485 QMS and supported BSI certification audits (certificate expected Q1 2022). Commenced FDA registration process.
- Performed a cybersecurity audit for a major pharma company which triggered an emergency supplier change away from their main strategic partner. Cybersecurity is an area we continue to see growth.
- Performed risk analysis and requirement management for a high-risk device (insulin pump) for Pharmasens (Switzerland) and we were selected to drive the project towards rapid FDA approval.
- Led the validation of the LIMS systems globally for Sanofi (France).
- Malsen Medical have been a leading contributor to enabling the pan-European FMD (medicines falsification) system across all pharma producers globally, all wholesalers, pharmacies, and national competent authorities across Europe. Last year we performed audits at local organizations (Norway), validated the major system release (Arvato, Germany) and continue to coordinate the actors to drive the implementation in France.
- Implemented the Malsen Medical development model to bring high risk medical devices to market under MDR/FDA across several major projects delivering resources in all disciplines.
Our team has been strengthened with 9 new consultants within areas such as QMS, usability engineering, validation, requirement management, medical writing, project leadership and regulatory. All of our consultants are industry leading experts with very significant experience. We will continue to grow our team in Norway and across Europe in the year to come.
Internally, we have worked to streamline Malsen Medical internal processes across our projects and sites to enable further growth and a harmonized delivery of services.
Thanks for a great, yet challenging, 2021! We really are looking forward to building on the cooperation of the last year and working with you more in 2022.