Sustainable practices and approaches in Healthcare
Sustainability is quickly becoming one of the main focuses of the healthcare industry in Europe, with multiple legislations already in place, in addition to future measures that will further promote and require more sustainable solutions from medical companies. These legislations will extend to medical devices, with the new regulations requiring companies to take on sustainable […]
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
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, […]
IVDR – Overcoming challenges while establishing Regulatory strategy
By Julia Selmani Regulatory Affairs specialist, Key2Compliance AB Establishing a strategy for regulatory compliance for your company is a new IVDR requirement, defined in Article 10(8a) where the aspects to be addressed by manufacturer’s QMS are listed. Thought ISO 13485 does not explicitly include requirement for Regulatory strategy, it includes the requirement to incorporate regulatory […]
Join our international 2-day conference in Copenhagen on the 4-5th of October!
This is a must-attend conference for all medical device professionals dealing with biological and/or clinical evaluations, Clinical operations, QA/RA Managers, R&D managers and CEO:s. This conference will address biological and clinical evaluations from a risk perspective through a mixture of presentations from standard developers, notified bodies, test houses and device manufacturers. The first day will […]
We are happy to welcome our newest team members!
Say hello to our newest colleagues: Mikael Rapp, Mia Trustrup Larsen and Sara Falkenklint! They are joining us to help continue doing what we love to do: make complex things easier – all the way from idea to market. MIKAEL RAPP, Chief Financial Officer What will be your role at Key2Compliance? I will be responsible for the […]
Welcome to join Innokas Medical and Key2Compliance´s Good Morning Meeting at Medicon Valley!
Optimal Regulatory and Design Development from Idea to Success of a Medical Device To succeed in taking a medical device product from idea to the market, both the design and development flow, as well as the regulatory flow need to be considered. As the inventor or manufacturer of a medical device, a key success factor […]
Key2Compliance Collaborates with Uppsala Innovation Centre’s Knowledge Platform
We at Key2Compliance are happy to announce that we have formed a collaboration with Uppsala Innovation Centre (UIC), one of the leading business incubators in Sweden, to produce videos for its knowledge hub. We are honored to be given this opportunity to partner with UIC while sharing a common goal of providing start-ups and scale-ups […]