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 […]
Understanding New Medical Device Regulations with Key2Compliance’s Clinical Development Experts

In recent years, regulations for medical devices have evolved significantly. The Medical Device Regulation (MDR) has been taken into effect, and in tandem, the In Vitro Diagnostic Medical Device Regulation (IVDR) has replaced the preceding IVDD. The new regulations MDR and IVDR, have elevated the level of requirements, adding emphasis on clinical evidence and a […]
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 […]
Gate2Compliance – the essential subscription service for Life Science professionals

Gate2Compliance is a service both for the Pharma and the Medtech industry, helping you to achieve regulatory compliance. You will get valuable content related to Quality Management, Biocompatability/GLP and Clinical evaluation. – The Free subscription contains a library with over 650 regulatory documents. As a Premium subscriber to Gate2Compliance you will have access to all […]
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. […]