Internal Audits – A Strategic Tool for Continuous Improvement
At GBA Key2Compliance, internal audits are more than a regulatory requirement. They are a proactive way to identify gaps, strengthen your quality system, and ensure you stay ahead of Notified Bodies and Competent Authorities. Our auditors bring deep regulatory knowledge and extensive hands-on industry experience. With expertise across MDR, IVDR, ISO 13485, and MDSAP, we […]
Internal audits – an opportunity to improve Medical Devices
Internal audits are an important activity for medical device manufacturers. It is not only a requirement for ISO 13485 compliance, but also an opportunity to get valuable feedback that can help to improve both the medical device and the development process. At GBA Key2Compliance, our experienced auditors support clients throughout the entire internal audit process – ensuring compliance, […]
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 […]
Meet Us at Regulatory Summit 2025!
GBA Key2Compliance is looking forward to participating in this year’s Regulatory Summit, organized by Swedish Medtech. Now in its 8th edition, this event is one of the most important meeting places of the year for industry experts and leaders to discuss and analyze the challenges and changes related to MDR. As a Networking Partner to […]
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 […]