Speaker announcement: Biological and Clinical Evaluations Conference

We are delighted to welcome Sofia Segersson, Ina Schäffner and Danielle Giroud as speakers at the Biological and Clinical Evaluations Conference for Medical Devices on the 4-5th of October in Copenhagen. – How life improves when the gadgets improve Sofia Segersson, Entrepreneur, influencer, founder, Diabetesia.se – Getting your product to the market – how clinical […]

Compliance Expert Insights on IVDR: Understanding the Impact

In-Vitro diagnostics

With the new In Vitro Diagnostic Medical Device Regulation (IVDR) in place, IVD manufacturers are now subject to much more stringent regulatory requirements and processes, especially when compared to the previous In Vitro Diagnostic Medical Device Directive (IVDD). These new regulations first became effective in 2017 to address key issues identified with the previous regulations. […]

Free Tutorials on Medical Device Regulatory Compliance Now Available on our Website

Our tutorials on medical device regulatory compliance are now available and can be accessed for free by clicking this link. Startups and scale-ups with limited experience on medical device regulations can refer to these tutorials to develop an understanding of the concepts and apply them to their development and market process. Given the complexity of […]

Swedish Key2Compliance and Canadian Ironstone Product Development enter partnership

Medical device and pharmaceutical consultants Key2Compliance have signed a collaboration agreement with Canadian Ironstone Product Development. The agreement gives Key2Compliance a stronger offering in North America and Ironstone a stronger offering in Europe. Key2Compliance has several years of solid experience and competence in the European market, both in terms of medical devices, In Vitro Diagnostics, […]