QA/RA Perspectives: Nadia Ragnvald Caspersen
A clear strategy starts with deciding what your first product needs to do For medical device and IVD companies, the path to market can become more complicated long before a submission is prepared. Decisions about product features, intended purpose and claims can all affect the regulatory and clinical work that follows. For Nadia Ragnvald Caspersen, […]
Beyond compliance in Bologna: sharing knowledge across borders
On 30 September and 1 October, GBA Key2Compliance colleagues Emily Malmberg and Maria Nordlinder travelled to Bologna to participate as invited speakers at Complife’s annual MDG Health Matters – Medical Device Governance Forum: Beyond Compliance. Complife, part of GBA Group, brought together representatives from across the medical device and IVD industry, including the Italian Ministry […]
QA/RA Perspectives: Lars Mentzer
Quality assurance and regulatory compliance are not something you can buy out of the box For medical device and IVD companies, bringing a product to market involves much more than meeting a list of regulatory requirements. It requires an understanding of why those requirements exist, how quality supports the organization and, ultimately, how it contributes […]
Biological Safety Support throughout the Medical Device Lifecycle
Is your Biological Evaluation Documentation ready for the latest ISO 10993 expectations? Biological safety is not a one-time regulatory activity. Throughout the medical device lifecycle, manufacturers must continually assess whether existing biological safety evidence remains sufficient as standards evolve and devices, materials, suppliers, and processes change. Regulatory expectations continue to evolve throughout the medical device […]
Welcome Gunilla Landin, our new Senior QA/RA Consultant
Gunilla Landin has recently joined GBA Key2Compliance as our new Senior QA/RA Consultant. With extensive experience in regulatory affairs across both pharmaceuticals and medical devices, Gunilla brings valuable knowledge and a broad perspective to our team. Gunilla is a pharmacist by training and has worked within regulatory affairs for most of her professional career. She […]
Nationella medicinska informationssystem (NMI)
Regulatoriska krav, praktiska utmaningar och vägen till regelefterlevnad Nationella medicinska informationssystem (NMI) är en grundpelare i Sveriges digitala hälso‑ och sjukvård. Dessa system möjliggör hantering, delning och långsiktig tillgänglighet av medicinsk information som är direkt relevant för patientvård på nationell, regional eller kommunal nivå. Mot bakgrund av deras betydelse omfattas NMI av ett särskilt svenskt regelverk: […]
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 […]
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 […]
Safety Data That Makes a Difference – Insights from Safety Manager Ida Björklund
In clinical studies, the responsibility for ensuring patient safety lies with both the sponsors and the clinical study staff. This is not only a regulatory requirement, outlined in standards such as the MDR (Medical Device Regulation) and IVDR (In Vitro Diagnostic Regulation), but also a core principle of Good Clinical Practice (GCP) and its ISO […]