Upcoming FREE webinar: What about Change management?

🤔 What about Change management? Do you have a systematic approach to identifying, managing, and implementing changes to your products and company? Do you have a change system so complicated that you avoid using it and instead sneak changes past it hoping not to get caught? Or is it somewhere in between? 💡 Sign up […]

Join our upcoming FREE Breakfastclub webinar!

☕ Get your coffee ready on April 12th, 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 Emily Malmberg, PhD in the discussions about IVD Software – the road to IVDR compliance! Take the opportunity to listen to the experiences from the IVDR […]

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 […]

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 […]

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 […]

Free webinar: Application for Clinical Investigations

How to prepare your submission package Learn from our experienced clinical development consultants which documents are required, what to consider and how to avoid delays. In this session, you will an overview on the documents and process required. It is teaser for the upcoming Key2Compliance training/course on Medical Device Clinical Investigations in May. Which documents […]

Free webinar: Is your medical device software MDR ready?

There are lots of great ideas and products related to medical device software today. Many of them already are compliant to the Medical Devices Directive (MDD), others are in an earlier development state. Since May 26th, 2021, the Medical Devices Regulation (MDR) is in force and latest May 26th, 2024, all medical device software has […]

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