Medtech and Pharmaceutical consultants Key2Compliance sharpens its Clinical Development offer and recruits experienced Business Developer and Project Leader Jeanette Demorney. “I believe I can contribute with a broader way of thinking about business development within a Medtech and IVD focused CRO”, she said. Jeanette Demorney has a solid background in both the healthcare and the […]
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 […]
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 […]
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 […]
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 […]
Let us introduce our newest colleagues: Linda Hansson, Tatiana Mattsson and Susanne Grimsby! They are joining forces with us to help continue doing what we love to do: make complex things easier – all the way from idea to market. LINDA HANSSON, Consultant Clinical Development What will be your role at Key2Compliance? I will be part […]
We are glad to share with you that our Key2Compliance team has recently been joined by two new team members – Erik and Susanna. We are excited to introduce you to these two talented additions to our team! ERIK BOM, Medical Device QA/RA Consultant What will be your role at Key2Compliance? I will work as […]
We are happy to announce that our team at Key2Compliance continues to grow steadily with another four new team members joining us. Please welcome Susanne El Makdisi, Oskar Öhman, Carmen Vogt and Christina Ehrenkrona on board! SUSANNE EL MAKDISI, Medical Device QA Consultant What will be your role at Key2Compliance? My role will be […]
