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 […]
Webinar – Is your AI software a medical device?
Artificial Intelligence is transforming healthcare, but determining whether your AI solution qualifies as a medical device can be challenging. Join our free upcoming webinar to gain a clearer understanding of the regulatory landscape for AI-based software. We will explore qualification and classification under medical device regulations, applicable laws and standards, and the pathway to market. […]
A New ISO Standard for IVD Performance Evaluation Is Taking Shape
Performance evaluation is central to demonstrating conformity under the EU IVDR. To date manufacturers have typically established their performance evaluation frameworks by drawing on the Regulation, MDCG guidance and several standards addressing individual parts of the evidence lifecycle. A new ISO project, currently under development, may eventually provide a more consolidated international reference for performance […]
Own-Brand Distribution Under MDR/IVDR: Who May Assign the UDI-DI?
Anna SahlholmConsultant manager, GBA Key2Compliance When the same medical device is sold under different trade names, it may seem logical for each brand owner to obtain its own UDI-DI. Under the EU MDR and IVDR, however, the decisive question is not who owns the brand, but who acts as the legal manufacturer. MDCG 2026-5 addresses […]
Zahra Mavajian takes on the role of Quality Assurance Manager at GBA Key2Compliance
Quality has always been at the heart of GBA Key2Compliance. As we continue to grow, maintaining a strong and practical Quality Management System becomes increasingly important. As part of that commitment, Zahra Mavajian has taken on the role of Quality Assurance Manager, alongside her ongoing work as a consultant. Many of our customers already know […]
When a notified body disappears: what TÜV NORD Scandinavia’s bankruptcy tells us
On 22 July 2026, TÜV NORD Scandinavia Medical Notified Body AB entered bankruptcy proceedings, shortly after being acquired from RISE. According to Bolagsverket, the Swedish notified body has now ceased operations. For manufacturers, it is a reminder that notified body capacity is not just a regulatory issue, it is also a business continuity risk. For […]
SEMINAR – Medtech or Healthtech? Classification, Funding, and Market Impact
MEDTECH NETWORK – MEDICON VALLEY ALLIANCE Where is the line between MedTech and HealthTech – and does it matter? We’re pleased to be part of the upcoming MVA Medtech Network event hosted by Medicon Valley Alliance on 25 August at Medeon Science Park in Malmö. As digital health solutions continue to evolve, the boundaries between […]
Strategic Communication Training for Quality Professionals
How do you turn “us vs. them” into a shared commitment to quality? Quality should belong to everyone in an organisation. Yet in many companies, quality-related activities gradually become associated with a single department. Requirements are introduced, objections arise, and before long an “us versus them” mindset starts to emerge. As a result, quality can […]
FREE WEBINAR – From Regulatory Strategy to Clinical Evidence for Medical Devices
A regulatory strategy defines the pathway that brings a medical device to market, from qualification and classification through to the planning of all activities required to demonstrate compliance. Building on this foundation, the clinical strategy determines how the evidence required to support the device is generated and documented. The integration of regulatory and clinical strategies is a key factor in guiding both development and business decisions, with a direct […]