Knowledge & Resources

Small MedTech companies in Europe face a multifaceted array of challenges, including navigating complex regulatory landscapes, securing funding, protecting intellectual property, and managing manufacturing processes. These companies also need to stay updated with rapid technological advancements, ensure compliance with regulations, and achieve clinical adoption and market access amidst stiff competition. These obstacles highlight the intricate […]

In the previous article about ISO 13131, our Data Privacy expert Roland Schnitter explored the structure and content of this standard. He also examined how ISO 13131 interfaces with quality management system standards like ISO 13485 and ISO 27001 and discussed the potential for effort reduction through the elimination of redundancies. So, how does ISO

ISO standard 13131 provides a framework for managing telehealth services as part of the medical device environment. It combines the baselines of standards for risk management and medical devices with regulatory requirements derived from the AI (Artificial Intelligence) Act, Data Act and GDPR. Laws / regulations / guidelines: ISO 13131:2021 ISO 13485:2016 ISO 14971:2019 ISO

It is born – EU Parliament has approved the AI Act The EU is now equipped with a brand-new regulation for the use of AI. Here are the top 3 insights: The EU has adopted a new regulation for the use of AI, intended to protect the fundamental rights of human beings and promote innovation

With effect of January 2024, Swissmedic has started with a reorganisation in order to distinct more clear intern responsibilities regarding market surveillance and medical devices. The new department Medical Device Surveillance is responsible for safety of clinical trials, materiovigilance and market monitoring of medical devices. See more infos on Swissmedic website.

The Benefits of Integrating an Information Security Management System to Medical Device Manufacturers   Medical device manufacturers face unique challenges when it comes to ensuring the security and privacy of sensitive information such as clinical data or intellectual property of design development. With the increasing prevalence of cyber threats and the need to comply with

Understanding EUDAMED – A Key Resource for Medical Device Registration in the EU In the vast landscape of medical devices, one may wonder how regulators manage the enormous amount of information related to manufacturers, product details, safety reports, and clinical trials. The answer, for those operating in the European Union (EU), is a robust, secure

Medical Device Authorized Representative:   What is an Authorized Representative: An authorized representative in the medical device industry refers to a legal entity or an individual that acts on behalf of a manufacturer in dealing with regulatory authorities. Their role is to facilitate the manufacturer’s compliance with legislation in the country or region where the

Swissmedic has performed inspections at class 1 manufacturers within Switzerland. The result is impressive, but not surprising due to our experience as Authorised Representative in EU, Switzerland and UK. During our onboarding process EUMEDIQ, we check not only completeness of Technical Documentation of our customer, we also do a plausibility check in order to estimate

In December 2022, the European Commission published the new directive (EU) 2022/2555 on measures for a common level of cybersecurity across the Union. This led to the amendment of the regulation (EU) 910/2014 on electronic identification and trust services for electronic transactions in the internal market (also known as eIDAS regulation) and repeals the NIS