IMed supports K2 Medical Systems in their EU MDR transition process –

K2 Medical Systems (K2) is a Plymouth-based company providing specialist maternity solutions that help clinicians improve standards of care for women and babies. Launched in 1999, K2 has gained international recognition for providing maternity professionals with the information they need to make better clinical decisions at the point of care and eliminate inefficient paper based processes, ultimately resulting in significantly lower incidence of poor birth outcomes.

K2 is a part of N Harris Computer Corporation, an international group that provides mission critical software solutions for the Public Sector, Healthcare, Utilities and Private Sector verticals throughout North America, Europe, Asia and Australia.

Acknowledging the need for support with their EU MDR transition, K2 reached out to IMed consultancy’s business development director Al Mills in early 2022.

IMed supported K2 throughout all the stages of the MDR transition, from performing external audit reviews to technical files and technical evaluations. With the help of IMed’s team K2 recently completed the second stage of their MDR transition and also assisted them in obtaining Article 97 compliance in 2023.

“We’ve now worked with IMed five times! We were really impressed with their professional approach and vast knowledge base, that really is second to none, especially when it comes to supporting clients with regulations and compliance.” says Mark Smith, Manager Quality Assurance at K2.

Impressed with IMed’s expertise and professionalism, IMed have become a regular go-to regulatory team for other Harris Computer business in Spain, Israel, Canada and the US, supporting, among others, the MDR transition process of other healthcare solutions under their umbrella: IMDSoft, global leader in clinical information systems from Israel, as well as US-based Picis Clinical Solutions with a location in Barcelona, a global provider of clinical information solutions in healthcare that automate the entire perioperative experience.