Five companies have to date been founded to create a chain of expertise within quality, regulatory, biocompatibility, clinical, and medical writing.
“Trust is key for everything here. The clients give us their trust in asking us to support them and give them the absolute best advice within the MedTech area, and this relationship often extends over several years. But it is also about trust between the five companies. We feel assured in each other’s expertise and making sure nothing falls between the cracks in an assignment with a client”, says Elisabeth Liljensten, CEO of Devicia and Limulus Bio.
The regulatory landscape for medical devices and in-vitro diagnostic medical devices (IVDs) is undergoing substantial changes. The requirements are getting more detailed and the control of adherence is tougher. All of this is happening while we are living through a global pandemic – something that really has stressed the importance of medical devices.
“Compliance is fundamental for MedTech companies to survive. Regardless of whether you are developing a new medical device, or you already have products on the market, you must constantly monitor what is happening with the regulations and the interpretation of requirements on the markets you are on, or plan to release your products to. There is no ‘one-size fits all’ way to do it. All companies have to adapt their compliance scheme after their product and organisation. The regulatory strategy is key to survive.”, says Åsa Runnäs, CEO of Clarvin.
A center of excellence is more than just words. You have to act on it. Expert knowledge require that you are always up to date with the new requirements and how they affect the different players in the MedTech community.
“As nominated experts working globally with standardization, our participation at the table provides our clients with an inside perspective to the changing regulations. This is a fundamental principle for all our companies. Additionally, during the past year we have shared our knowledge through white papers, webinars, Limulus Bio’s digital coffee breaks and most recently the MDR podcast, which we have established together with SwedenBIO”, says Sofia Nordgren, CEO of Kickfile.
Monica Grekula is the Director of Biocompatibility and Toxicology at Limulus Bio. She emphasises the importance of being visible and able to influence. “We want to share knowledge across the world by connecting people. That is why we are setting up the conference Biocompatibility Matters in Copenhagen May 3 – 5, 2022. We have already seen an amazing response to our conference, that over three days will include e.g. training programs and? open seminars. And we have the absolute “crème del la crème” of top global experts and speakers, both from EU, US and Asia-pacific.”
Offering services to meet the needs of a global client base has been key since day one. The latest incorporation Lea Reg, was founded based on a need from a US client for an EU Authorised representative.
“We saw a need and acted on it. The clients want to stay with us and when they need new services, we can act fast based on our close-knit executive team. As a continuation to Lea Reg AB in Sweden, we now have Lea Reg registered in the UK where we can act as UK Responsible Person and help clients place products in the UK”, adds Åsa Runnäs. (editorial remark: UK Responsible Person is needed after Brexit).
“Maybe it is a cliché, but we are really passionate about supporting our clients in all aspects. The regulations are tricky and expert knowledge is needed to tackle the requirements in the best way. Expertise is required in so many different areas – from clinical and biological safety to software, sterilisation, production and post-market surveillance. It is impossible for one person or even one company to have it all. With our collaboration we can provide this”, says Lina Burman, Senior Scientific Officer.
Many of the services offered by the five collaborating companies are unique to them. Even better – all operate on a one-contact basis, which means that clients can get help with their specific questions regardless of whom they contact at Devicia, Kickfile, Clarvin, Limulus Bio or Lea Reg. Clearly, collaboration is key.
So, are there any new companies in the pipe?
“Yes! A strong global presence has always been at the core of our strategy, and in addition to having our companies registered in Sweden, USA, and UK we are about to launch our first company in the Asia-Pacific. More to follow soon”, concludes Sofia Nordgren.
Meet the companies:
Clarvin offers expertise and guidance within Regulatory Affairs and Quality Assurance exclusively for medical devices and IVDs. Focus is to make the clients’ regulatory processes as predictable and reliable as possible.
Devicia is a full-service CRO Partner exclusively focused on medical devices and IVDs. The company supports MedTech companies throughout the complete life cycle of medical devices – from idea, market access to post-market surveillance and follow-up.
Kickfile offers cloud-based access to document systems supporting compliance. With Kickfile, MedTech companies get access to the systems needed for putting a medical device on the market – in a compliant and predictable way.
Limulus Bio offers support within Biological evaluations & Toxicology consultancy and training – with a global perspective. To meet the strict requirements in a compliant manner, Limulus Bio supports clients with comprehensive risk assessment strategies and biological evaluations.
Lea Reg can act as EU Authorized Representative and UK Responsible Person for medical device and IVD companies placing products on the EU and/or UK market.