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 […]
SUMMER CAMPAIGN – 20% OFF ALL PUBLIC COURSES
Now is the perfect time to plan ahead and secure upcoming training at a discounted rate. Register before 31 August 2026 and receive 20% discount on any public course offered during 2026. Our expert-led training helps professionals navigate complex regulatory requirements with practical and applicable knowledge across areas such as: GMP & GXP Medical Devices […]
Training for Sterilization Validation and Regulatory Compliance in Oct
Can you prove that a Medical Device is truly sterile? A medical device is ready for launch. The design has been finalized, testing completed, and documentation approved. Months, perhaps years, of work have led to this moment. But before the product reaches a patient, one critical question remains: How do you prove that it is […]
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: […]