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
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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
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New update from MDSAP Audit Approach, at a glance: Australia got some more detailed requirements regarding Assessment Technical Documentation and Agreements between Sponsors and Manufacturers Update of Design Output requirements for Technical Documentation and DHF Auditors shall search for evidence of inclusion of feedback into risk management, both Product and Processes Clarified equirements for NC
New update from MDSAP Audit Approach – MDSAP-AU-P0002.008 Read More »
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
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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
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In the coming months, we will introduce you to the team. Let’s start with: Lisa! What is your field of expertise? I am mainly responsible for design transfer. I help to ensure that newly developed products also make it to production. My specialty is process development and risk management, making sure all processes run smoothly. I am a safety expert for non-active medical devices and support with sterilization
Who is EUMEDIQ, anyway? Let’s start the series with: Lisa! Read More »
Top 4 changes in EUDAMED release v2.10: a) Actors module: Actors can be set to inactive mode – PRRC will not be displayed then – Termination date of a mandate will be displayed b) UDI/Device module: Search UDI’s more detailed – Devices by a manufacturer for which a Competent Authority is responsible – Devices by
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BREAKING NEWS – EUMEDIQ Ltd. has opened its office in London! EUMEDIQ is now providing UK, EU and Swiss Authorised Representative Services next to Consulting (MDR, IVDR, GDPR and ISO 27001 and ISO 13485) and Auditing Services. Further benefits: More wins with maximum efficiency Your qualified partner to reach your target markets High degree of automation and
BREAKING NEWS – EUMEDIQ Ltd. has opened its office in London! Read More »