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 […]
Our QA/RA consultants shine – both as experts and photographers!
Recently, our QA/RA team gathered for an inspiring workshop where we not only deepened our expertise but also explored our creative side. We participated in an engaging activity led by Catarina Harling, Photographer and Teacher from the Fotografiska Museum. She taught us how to effectively use our iPhones for photography, with a particular focus on […]
What It Takes to Keep a Clinical Study Going
– Meet Clinical Research Associates Ana Zamani and Susanna Hellström Clinical studies aren’t just about data collection. It’s about keeping studies on track through operational teamwork and navigating challenges in real time. For Ana Zamani and Susanna Hellström, Clinical Research Associates (CRAs, also called Monitors) at GBA Key2Compliance, this human side of clinical studies is […]
Inside the Role of a Clinical Project Manager – Meet Anna Östblom
Clinical investigations are complex by nature. With tight timelines, limited budgets, and regulatory expectations, they demand coordination at every level. That’s where experienced project managers like Anna Östblom come in. “What might surprise people is how much time it actually takes to manage a study,” says Anna. “My work is less visible compared to for example the […]