The Importance of Understanding Medical Device Classification
In the process of putting a medical device or an IVD product on the market, one of the first and most important steps is correctly identifying its risk classification. In a nutshell, medical device classification is a regulatory process used in categorizing medical devices based on their intended use, as well as potential risks to […]
Join our upcoming FREE Breakfastclub webinar!
It’s time for another one of our FREE Breakfast Club Webinars! Get your coffee ready on December 8th, 9.00 – 9.30 and take part in this knowledge sharing webinar! Software classification and MDR – why are most MDSW not class I anymore and what does it imply? During the MDD era, many Medical Device Software (MDSW) […]
Upcoming FREE Webinar: What about CAPA?
See the recorded webinar here >> What about CAPA? Do you have a systematic approach to identifying, addressing, and preventing issues that could impact product quality or patient safety? Do you have death by CAPA? Or is it somewhere in between? Sign up for our upcoming FREE WEBINAR on December 6th, at 09.00! Join a 40-minute theoretic […]
Jeanette Demorney; the new Director of the Clinical Development business area
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 […]
FREE Webinar: What’s the point of the Clinical Evaluation?
Performing a medical device clinical evaluation is cumbersome and costly, but join this webinar and let Maria Lindgren explain why it is still worth it! These three aspects will be discussed: Performing the clinical evaluation early can save time and money Remember that there are three sources for clinical data Knowing the state-of-the-art of your […]
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