Sön 14 jul / År 42 / Nr 3 2024

Life Science 2021

The task of developing the healthcare systems, technology and treatments of the future requires a much sharper focus on facilitating collaboration across borders. Not only geographical – but across disciplines as well. Gothenburg has a strong and growing Life Science cluster which deserves to be highlighted from a national point of view.

Making complex things easier in Medical Device

Keeping track of Regulatory affairs, Quality Assurance, Clinical Development, IHC guidelines and Biological Evaluations is not a walk in the park. The task requires years of hands-on experience and well-established collaboration networks, as well as the ability and tools to monitor continuous changes and updates of current regulations.

Pharmaceutical companies, In-Vitro Diagnostic Companies and Medical Device developers are among the most regulated businesses in the world, with ever increasing requirements. For individual innovators or SMEs, it can be difficult to keep track of changes in the legislation and new requirements concerning their activities. On top of that – failing to meet a new requirement can be costly and in the worst-case result in project shut-down.  

Key2Compliance facilitates the process by keeping track of what applies to each client’s business as well as their products. As from 2020, Key2Compliance is a part of Symbioteq, a company that has helped many medical technology companies to achieve success over the years through guidance in the complex process of product development from idea to market and beyond.

Everything in regulatory compliance

Thanks to the Symbioteq ownership, Key2Compliance has access to decades of experience when it comes to all aspects of regulatory compliance. This provides for a strong portfolio of both regulatory and training services aimed at developers of new medicines, treatments, and medical devices. A comprehensive list of services includes everything concerning Regulatory Affairs, Quality Assurance, Biological Evaluations & Toxicology and Clinical Development. In addition, Key2Compliance can meet all training needs in terms of regulatory requirements, GXP and quality systems for the pharmaceutical and medical device industries.

“To put it simply; we make complex things easier. That is our main goal and our promise to our customers”, says Jan Hellqvist, CEO at Key2Compliance. “Most pharmaceutical and medical device developers need guidance to come to terms with new and changing regulations. They also need competent hands on support in times of high workload. Not least concerning the new regulations of medical technology products, MDR, enforced in May this year”.

Jan Hellqvist explains that the new regulations of MDR means that the EU common legislation is retained but with increased requirements on manufacturers to prove both usability and safety of their products. What is also new is that importers and distributors are covered by the new legislation. There are also increased demands on review bodies (so-called notified bodies) and medical technical authorities such as the Medical Products Agency.

“As the requirement for evidence increases, so does the need for clinical trials. Therefore, we wanted to be prepared and that is why we established the clinical development business area within Skey2Compliance in 2020. We are now a team of 10+ experts that can perform clinical investigations, evaluations and more on a global scale. Everything has a purpose and is connected”.

What happens next?

When regulations change, there will naturally be more focus on education as everyone needs to prepare themselves to follow the new regulations. After MDR, the corresponding In Vitro Diagnostic Medical Devices Regulation (IVDR) is scheduled for enforcement in May 2022.

“In recent years, there has been a heated discussion about product safety in both Europe and the United States. The answer is the updated and new regulations within MDR and IVDR. Many companies that work with in-vitro diagnostics have difficulty interpreting the new regulations. That is why we exist”, says Jan Hellqvist.