Medical Devices, Pharmaceuticals, Life Sciences, IT & Health Tech
We are pan-European consultants who help companies bring innovative products to market in controlled environments. Why MalsenGet in touchOur Expertise
At Malsen, we have extensive experience of all stages of the product and company life-cycle; from the initial product conception, industrialisation, through to local and global market launch with our support all of the way. We enjoy complex technical and political challenges in controlled environments, where the best practices need to be deployed company wide.
News
June Newsletter
The last month was such a busy one! Several key projects went into their next phases after the checkpoints were successfully met.
Malsen Germany has officially launched now.
April
At Malsen Medical we believe in the importance of building a team to support all of our customers through the varied and exciting projects that we work within. This month, with that in mind, we decided to work on our team and leadership skills in greater depth. There...
March
Monthly Newsletter As some of you have already noticed we are recruiting for three full time positions within Malsen Medical due to the many projects we are now project managing. The people we are looking for are a Requirements Manager, Project Manager, and...
February
The busy start to the year continues! So far, Malsen have been delighted to welcome several new members to our team this month. We now have amongst our ranks, a new senior QA consultant, and a new senior requirements manager. We are pleased to welcome a new COO, Erik...
January
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...
EpiGuard awarded ISO 13485
We are proud to have supported EpiGuard to achieve their ISO 13485:2016 certification. It was a great challenge and involved many people working together as a team to get there. It is a fantastic achievement and shows their commitment to safety, quality, and...
Selected customers
Diagnostica
Diagnostica is a medical IT company that markets the product Spirare used by health care professionals to visualize and manage data gathered from several modalities. Malsen Medical created the technical file for compliance to MDD and associated QMS. Full compliance to...
Pharmasens
Pharmasens, as Swiss based company, are developing a ground breaking insulin delivery platform. Malsen Medical is helping to drive the project is several areas including risk management, specification and requirement management, compliance planning, FDA submission...
IVF-FIT
IVF fit are an IVD company who are developing a novel test method to improve the chances of successful in-vitro fertilisation. Malsen have been supporting the team to structure the organisation, working with QMS and project documents. We have also used our extensive...
Arvato
Global IT specialist, Arvato Systems, support major companies through digital transformation. As a Blueprint Service Provider of the European Medicines Verification Organisation, they offer the 28 European member countries as well as the other non-EU members a tried...
EpiGuard
EpiGuard is the medical device company responsible for the revolutionary EpiShuttle product. EpiShuttle is central to the safe transport of COVID-19 patients. Malsen Medical have been involved with EpiGuard for several years to set up their QMS, Design History File,...
Vision statement
Our vision at Malsen is to be the partner of choice for companies operating within medical devices, in vitro diagnostics and pharmaceutical sectors. We develop long-term trusted relationships, and provide reliable solutions with lasting results to our clients. We thrive on seeing successful products brought to market, knowing that we contributed to our client’s success.
