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, […]
Outsourcing Internal Audits in MedTech: Strategic Advantage or Regulatory Risk?
Nadia Ragnvald Caspersen Senior consultant, Medical Device QA – GBA Key2Compliance In the medical device industry, internal audits are a vital part of maintaining compliance, ensuring product safety, and preparing for regulatory inspections. But as companies face increasing complexity, limited resources, and the pressure of unannounced audits, many are asking: Is it acceptable to outsource […]
Quality and Compliance for ATMPs – A Strategic Enabler for Patient Access
Afifa Trad Senior consultant, Pharma QA – GBA Key2Compliance Advanced Therapy Medicinal Products (ATMPs) are transforming the treatment landscape for complex and previously untreatable diseases. By leveraging gene therapy, cell-based treatments, and tissue engineering, these therapies offer truly personalized solutions. But with innovation comes complexity—and success depends on one key factor: a robust strategy for […]
GBA Key2Compliance supports BOHUS with comprehensive CRO services
GBA Key2Compliance Enhances Quality Assurance, Regulatory Compliance, and Clinical Investigation for BOHUS At GBA Key2Compliance, we take pride in our role as the primary CRO for BOHUS, a Swedish company dedicated to producing high-quality hyaluronic acid (HA) products. Specializing in ophthalmics, aesthetics, and orthopedics, BOHUS extends its market reach to over 60 countries in the […]
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 […]
Webinar – Elevate your Career: Insights on progression within MedTech Quality Assurance
Join us for a live webinar exploring the many opportunities within Quality Assurance for MedTech Professionals, hosted by industry experts from Key2Compliance Whether you are just starting out or looking for mid-career progression, this webinar will equip you with practical strategies and actionable steps to support a successful career in MedTech Quality Assurance. You’ll have […]