Utilising Clinical Strategy with Expert CRO Guidance from Key2Compliance

Clinical strategy

With the complexity of medical device regulatory compliance today, having a well-thought-out clinical strategy can help make the process smoother. In a nutshell, clinical strategy refers to comprehensive planning and implementation of the clinical development process for medical device manufacturers. A well-conducted clinical strategy ultimately results in the approval of their product and its successful […]

A detailed examination of Laboratory-Developed Tests (LDTs) and In-House Devices

Zahra Madijahn Consultant, Regulatory Affairs The Power of Precision Medicine Laboratory-developed tests (LDTs), generally known as in-house devices, play a crucial role in diagnostic laboratories worldwide. Although both in-house devices and LDTs are created and utilized within a healthcare facility, the term “LDT” is generally used in a more specific context to refer to tests […]

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 […]

Usability Documentation for Your Medical Device

Usability documentation

Malin TruvéRegulatory Affairs consultant, Usability expert Are you about to perform a Usability evaluation for your medical device and are unsure of what usability documentation that are needed? There are three common mistakes that a lot of people make. This blog to help you avoid some of the pitfalls. The advice is based on fulfilment of […]



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