From regulatory strategy to market launch – by RegSmart Life Science

To comply with MDR and IVDR, a quality system (QMS) according to ISO 13485 must be implemented. To avoid unnecessary cost and time, it is essential for MedTech and IVD companies to develop a pragmatic quality assurance (QA) strategy and carefully plan what to start with.

What is the intended purpose, and who is the intended user?

Defining the intended purpose carefully in the early phase is essential to avoid extra work later in the QA process. In addition, defining the intended user is important as it can have a significant impact on how you need to scope your QMS.

When do you need a clinical investigation?

Performing a clinical investigation is a costly and complex process. For certain products is it mandatory to conduct a Clinical Investigation, but in many cases, you can save money and time using existing scientific data to collect clinical evidence and develop your Clinical Evaluation Report.

Speaker Mats Högberg is Director Medical Device & IVDR at RegSmart Life Science. Mats has more than 25 years extensive experience in leading MedTech organizations from idea to market launch. Before taking the position as Director at RegSmart he worked as CEO at Pharmacolog, a public company traded at Nasdaq First North.

RegSmart Life Science is a regulatory consultancy firm in pharma and medical device that will help you navigate in a complex and evolving regulatory landscape. They assist medical device, diagnostic and pharma companies in defining and implement a balanced, cost efficient, regulatory and quality assurance strategy.