My trip to Ukraine with Smart Medical Aid – A Doctor’s journey
Join us for a good cause as Gianluca Colucci, a dedicated laparoscopic and colorectal surgeon and a volunteer for SMART Medical Aid, hosts a webinar to share his invaluable experiences in Ukraine. Free webinar with Gianluca Colucci and SMART AID Medical Gutta cavat lapidem (the water drop bores through the rock) has been one of […]
Join our upcoming FREE webinar about the new toxicology standard!
New edition of the toxicology standard ISO 10993-17 – what has changed? The ISO 10993-17 standard has been revised and a new edition was finally released in September this year. With a new title, new scope and new statements added on its applicability, the standard now clarifies when toxicological risk assessment is needed, how […]
A warm welcome to our newest team members!
Say hello to our newest colleagues: Suzan Forsberg and Nadia Ragnvald Caspersen! They are joining us to help continue doing what we love to do: make complex things easier – all the way from idea to market. SUZAN FORSBERG, GMP and GDP QA Specialist What will be your role at Key2Compliance? I’ll be working 100% […]
Meet us at E-Sundhedsobservatoriet 11-12 October
Attention Software developers! Is you software a medical device? Are you prepared for MDR? Key2Compliance specialize in guiding software companies through the complex process of CE certification. Join us at our stand at E-Sundhedsobservatoriet on the 11-12th of October and talk to our experts Susanne Søeborg and Cecilie Bengtsen. Whether you need assistance with the entire certification project […]
Meet us at Medicinteknikdagarna October 9-11th
Come and meet us at Medicinteknikdagarna on October 9-11th! Visit our stand and have a chat with our experts Tomas Camnell and Helena Dahlin and learn more about Key2Compliance and how we make complex things easier for Medical Device and IVD companies. We hope to see you there! 📅 October 9-11th 📍BioClinum, Karolinska Sjukhuset, Stockholm
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 […]