FDA recognises the ISO 14155:2020 as a consensus standard

On December 21st 2020 FDA added ISO 14155:202 on the list of Recognised Consensus Standards. Worth noting is that the FDA highlights its application for post-market clinical investigations: “the principles set forth in this document are intended to be followed as far as relevant, considering the nature of the clinical investigation (see Annex I).” Read […]

Free BSI Webinar – UKCA for Medical devices and IVDs, are you ready?

Free live webinar Join BSI’s Dr Jayanth Katta, Head of UK Approved Body, Regulatory Services, to hear the latest updates on Brexit and the new UK Conformity Assessed mark (UKCA) for medical devices. More information: https://www.bsigroup.com/en-GB/medical-devices/brexit-medical-devices/ Register: Tuesday, 12 January, 2021 9:00 – 10:00 GMT Tuesday, 12 January, 2021 16:00 – 17:00 GMT

EUDAMED Actor registration module available from December 1st

From today EUDAMED (European Database on Medical Devices) is open for Actor registration to obtain a single registration number (SRN). This is the first of 6 modules. Every economic operator – EU and non-EU manufacturers, authorised representatives, system/procedure pack producers and importers) has to register as an actor in EUDAMED and provide the required information: […]

Emma Pedersen – New director for Biological Evaluations & Toxicology

Say hello to Emma Pedersen! New director for Biological Evaluations & Toxicology at Key2Compliance®. Emma Pedersen comes from 11 years at RISE (Research Institutes of Sweden) working as a research scientist, mainly with biological evaluation of medical devices according to ISO 10993 (including in vitro testing under GLP) and replacement of animal testing methods for […]

Focalcube – A competent eQMS at an unbeatable price

focalcube

An easy to use and competent cloud solution for quality management provided by Medos made available through Key2Compliance. Key2Compliance now offer our customers the introduction of a QMS directly in Medos cloud solution for quality management – Focalcube. Focalcube is the IT support for any company in the industry, who want to start a new […]

QA/RA Manager for hire

We offer interim Quality and Regulatory Managers for hire on part time or full time. Why hire a full time employee when you can contract a Senior and highly experienced RA/QA Manager part time. Our experienced RA/QA managers have access to the entire Key2Compliance team and network to solve even the most challenging of issues. […]

Symbioteq & Key2Compliance® joining forces

medical device consulting, compliance training

Symbioteq Holding AB has acquired Key2Compliance AB and formed a new Company under the joint name Key2Compliance® Symbioteq Kvalitet AB and Key2Compliance AB have become one company. The joint company is called Key2Compliance® and is a company within the Symbioteq group. The parent company is called Symbioteq Holding AB Another novelty is that in addition […]

A word from our CEO

A changing regulatory landscape The reality for companies involved in the development of medical devices and in vitro diagnostics is changing. New regulations for medical devices (MDR) and in vitro diagnostics (IVDR) generate completely new requirements on documentation, data and quality management. At the same time, the product life cycle has become shorter and competition […]