White Paper on Photobiomodulation and Red-Light Therapy Market Access
GBA Key2Compliance has published a new white paper titled Photobiomodulation (PBM) Across Wellness and Red-Light Therapy Markets – From Product Definition to Scalable Market Access. The paper addresses the rapid growth of PBM-based red-light therapy products across wellness, performance, aesthetic and longevity markets, and the strategic challenges that emerge as these markets mature. Rather than […]
Åse Ek – Leading the Next Chapter of Training & Education at GBA Key2Compliance
Insights on medical device training, regulatory compliance and the future of learning in MedTech. With more than 20 years of experience from the Medical Device and Pharmaceutical industries, Åse Ek has built her career at the intersection of product development, quality and regulatory affairs. Today, she leads the Training & Education area at GBA Key2Compliance, a role that combines […]
Breakfast seminar – Right from the start, AI-based medical devices
April 14th, 08:00–10:30 at GoCo, Mölndal Curious about how to successfully develop and scale AI-based medical devices from the very beginning? Join us for a breakfast seminar where we bring together experts and peers to share insights, discuss real challenges, and explore practical approaches. With an incredible line-up of presenters, moderator, and panelists, and an […]
Regulatory summit 2026
We were pleased to take part in Regulatory Summit 2026, hosted by Swedish Medtech. The event brought together professionals from across the MedTech industry for insightful discussions on the latest developments in RA/QA and MDR. A special highlight for us was seeing our partner Pia Lanneberg on stage, presenting “Communication that makes a difference”, an […]
Timing is Everything: The Crucial Role of QMS in Your Medical Device Journey
Nadia Ragnvald Caspersen Senior consultant, Medical Device QA/RA- GBA Key2Compliance For startups in the medical device sector, the timing of your Quality Management System (QMS) implementation can significantly influence your path to market and the submission of your technical file. While it may be tempting to focus solely on product development, integrating a QMS early […]
Quality Culture -Technology helps, but people make it work
Nadia Ragnvald Caspersen Senior consultant, Medical Device QA/RA – GBA Key2Compliance Picture this: You’re racing to meet a production deadline, juggling compliance requirements, and fighting to keep costs under control. Amid all that pressure, one question looms large: How do we make quality more than a tick-box exercise? Because quality isn’t just a requirement. It’s the backbone of trust, the measure of […]
Quality Risk Management, Powered by People
Nadia Ragnvald Caspersen Senior consultant, Medical Device QA/RA – GBA Key2Compliance Building better systems through respect, teamwork, and ongoing improvement Quality management isn’t just about systems and standards—it’s about people. Every device we help bring to market is ultimately used by someone who trusts it with their wellbeing. As QA/RA professionals, our responsibility goes far beyond compliance; it’s about safeguarding lives, supporting clinicians, and earning […]
Can You Measure Your Quality?
Dr. Peter L. Knepell President of Peak Quality Services If you want to buy an electronic thermometer, a blood pressure cuff, a pulse-oximeter, or a blood glucose meter, you probably do not give much thought about its accuracy or precision. Should you? More importantly, how about manufacturing these or other medical devices that depend on […]
Clinical Evaluation in MedTech – Expert Insights from Sandra Sernbo for Building Safe Medical Devices
At GBA Key2Compliance, the Clinical Research Organization (CRO) team is not only responsible for navigating regulatory requirements but also for ensuring that medical devices make their way into the hands of patients safely and effectively. In a field where innovation is critical but patient safety is non-negotiable, clinical evaluations play a vital role. At the […]
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 […]