Medical Device Classification Under MDR & IVDR: What Manufacturers Need to Know
Why Medical Device Classification Matters If you’re a medical device or in vitro diagnostic (IVD) manufacturer, one of the first regulatory hurdles you’ll face is classification. This might sound like a technicality, but getting it right is crucial—it determines how much regulatory oversight your product needs, how long it will take to get to market, […]
The New Required Role of Person Responsible for Regulatory Compliance
The new medical device regulations MDR and IVDR have introduced a new role: Person Responsible for Regulatory Compliance (PRRC). According to Article 15 of MDR and IVDR, manufacturers of medical devices are now required to have a designated person who will be responsible for regulatory compliance (PRRC), ensuring that all post-market surveillance and obligations are […]
FINAL CALL: Only 6 Days Left! Join us for the Medical Device Product Life Cycle Conference
Don’t miss our international conference tailored to navigating the complexities of medical device regulations and standards. Why Attend? Gain invaluable knowledge from top industry leaders who will simplify complex processes and provide essential tools for success. Whether you’re in Quality, Regulatory, Design & Development, Clinical/Performance Evaluations, or Post-Market Surveillance, this conference is essential for staying […]
Top Speakers at the Medical Device Product Life Cycle Conference: October 8-9
Don’t miss our international conference designed to navigate the complexities of medical device regulations and standards. This is your chance to gain essential knowledge and insights from top industry leaders who will simplify complex processes and provide invaluable tools. Why Attend? Whether you’re a Quality or Regulatory specialist, involved in design and development, clinical/performance evaluations, […]
Don’t Miss Out! Register Now for Our October Conference on Medical Device Regulations in Stockholm
Don’t miss out on our upcoming Medical Device Product Life Cycle conference on October 8-9 in Stockholm, Sweden! Join us for an international event dedicated to navigating the complexities of medical device regulations and standards. Our speakers are industry leaders ready to equip you with essential knowledge and tools, making complex processes simpler. This is […]
Speaker announcement: Medical Device Product Life Cycle Conference
Exciting Announcement! Meet three of our speakers for the Medical Device Product Life Cycle Conference Join us on October 8-9 in Stockholm, Sweden for our international conference dedicated to navigating medical device regulations and standards. Our expert speakers will share invaluable insights and tools to simplify complexities in product safety and regulatory compliance. 🔹 Judith […]
A detailed examination of Laboratory-Developed Tests (LDTs) and In-House Devices
Zahra MadijahnConsultant, 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 made […]
Navigating Medical Device Regulations – Insights from Our Danish Consultants
Cecilie Bengtsen, Mia Trustrup Larsen, and Nadia Ragnvald Caspersen Key2Compliance has in the past two years expanded its Nordic presence with a dedicated team of regulatory compliance consultants in Denmark. The expansion is timely, given the increasingly stringent compliance requirements for medical devices introduced by the Medical Device Regulation (MDR) and the In Vitro Diagnostic […]
IVDR – Overcoming challenges while establishing Regulatory strategy
By Julia Selmani Regulatory Affairs specialist, Key2Compliance AB Establishing a strategy for regulatory compliance for your company is a new IVDR requirement, defined in Article 10(8a) where the aspects to be addressed by manufacturer’s QMS are listed. Thought ISO 13485 does not explicitly include requirement for Regulatory strategy, it includes the requirement to incorporate regulatory […]
Key2Compliance Collaborates with Uppsala Innovation Centre’s Knowledge Platform
We at Key2Compliance are happy to announce that we have formed a collaboration with Uppsala Innovation Centre (UIC), one of the leading business incubators in Sweden, to produce videos for its knowledge hub. We are honored to be given this opportunity to partner with UIC while sharing a common goal of providing start-ups and scale-ups […]