Join our unique Breakfast Event!
🔬 Are you looking to gain a better understanding of how to prepare for clinical investigations? We’ve put together this unique breakfast tailored to the challenges of clinical investigations in the MedTech sector. Join our experts Maria Lindgren and Jeanette Demorney as they explore and discuss essential topics related to this specialized field. This event provides you with a […]
Medical Device Product Life Cycle – Boosting medtech knowledge together!
SAVE THE DATE Join our Medical Device Quality Assurance and Regulatory Affairs conference on the 8-9th of October in Stockholm, Sweden. This is an international conference focused on navigating the world of medical device regulations and standards. Our speakers will share their knowledge and tools to help you make complex things easier! We will outline […]
Join our upcoming FREE Breakfastclub webinar!
☕ Get your coffee ready on February 2nd, 9.00 – 9.30 and take part in another one of our FREE knowledge sharing Breakfast Club Webinars! Welcome to join our experts Stina Gustafsson and Malin Borg in the discussions about EU Artificial Intelligence (AI) Act and Medical Device Software! 🤖 December 9th 2023, the Council and the European Parliament reached a […]
Building a Stronger Future: Key2Compliance becomes part of GBA Group through acquisition
Hamburg/Stockholm, 16th January 2024. With the acquisition of the Swedish company Key2Compliance AB (Key2Compliance), GBA Group is expanding its range of consulting and training services for the medical device, In Vitro Diagnostics (IVD), and pharmaceutical industry. GBA Group is thus taking another important step towards establishing itself as a broad service provider for international customers […]
Borderline Medical Devices
Olivia SunSenior Consultant Regulatory Affairs Have you ever been unsure of whether or not the device you are working with is a medical device? Don’t worry, most of us have. Medical devices are based on a wide spectrum of technologies. In fact, there are about 2 million different kinds of medical devices on the world […]
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 […]