Key2Compliance takes over long-standing sterilization training
The course Sterilization of Medical Devices has existed for over 30 years and hundreds of people have graduated from it. Now, Key2Compliance has acquired the course, which is the only one of its kind in the EU. ”We are extremely happy to be able to offer this unique and very successful course”, said Åse Ek […]
Meet our speakers at the Biological and Clinical Evaluations Conference for Medical Devices
We are excited and proud to have some of the most experienced speakers within the industry present at our Biological and Clinical Evaluations conference in Copenhagen on the 4-5th of October. Meet our speakers: Lisa Moloney, Principal Technical Specialist & Scheme Manager, Orthopaedics & Dental , BSI Notified Body Biological evaluation over the life cycle […]
The survival of devices following EU – MDR and FDAs more stringent scrutiny on clinical data
It has been predicted that 50% of all medical device products on the European market will vanish after the MDR curtain has fallen. This produces huge opportunities for companies that are proactive and understand that MDR is not a problem but rather an opportunity. The biggest impact on life for medical device companies following MDR […]
Lisa Moloney from BSI – speaker at Biological and Clinical Evaluation Conference
We are happy to welcome Lisa Moloney, Principal Technical Specialist & Scheme Manager, Orthopaedics & Dental at BSI as speaker at the Biological and Clinical Evaluations Conference for Medical Devices on the 4-5th of October in Copenhagen. 𝗕𝗶𝗼𝗹𝗼𝗴𝗶𝗰𝗮𝗹 𝗲𝘃𝗮𝗹𝘂𝗮𝘁𝗶𝗼𝗻 𝗼𝘃𝗲𝗿 𝘁𝗵𝗲 𝗹𝗶𝗳𝗲 𝗰𝘆𝗰𝗹𝗲 𝗼𝗳 𝗮 𝗺𝗲𝗱𝗶𝗰𝗮𝗹 𝗱𝗲𝘃𝗶𝗰𝗲 – 𝗔𝘀𝗽𝗲𝗰𝘁𝘀 𝘁𝗼 𝗯𝗲 𝗰𝗼𝗻𝘀𝗶𝗱𝗲𝗿𝗲𝗱 The biological evaluation should address the […]
Learn more about IVDR from the experts!
Key2Compliance has summarized some of the key challenges of the IVDR transition in a webinar. The webinar features expert consultants and industry professionals and helps companies understand the new regulations, and what its implementation means for them and their IVD devices. The speakers tackle various topics on the subject, ranging from key changes in the […]
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, […]