Making complex things easier in Medical Device
Keeping track of Regulatory affairs, Quality Assurance, Clinical Development, ICH guidelines and Biological Evaluations is not a walk in the park. The task requires years of hands-on experience and well-established collaboration networks, as well as the ability and tools to monitor continuous changes and updates of current regulations. Pharmaceutical companies, In-Vitro Diagnostic Companies and Medical […]
New office in Gothenburg
We are happy to announce the opening of a brand new office in Gothenburg. Last year we moved in to the new head office in Stockholm and simultanousely we opened an office in Lund. Our business is growing and we need an office in western Sweden and the location next to Chalmers University of Technology […]
How and when to update your Clinical Evaluation Report (CER)
In general a CER needs to be updated anywhere from at least annually, up to every 5 years, depending on the risk class and how well-established the device is – definately it should be updated after certain trigger events. Learn more about this by watching this video and by taking part in our course “Clinical […]
LMV informerar om kliniska prövningar relaterat till MDR
Hur vet jag om en studie är en klinisk prövning av medicinteknisk produkt? Läkemedelsverket har tagit fram en film för att förtydliga vilka kliniska studier som omfattas av bestämmelserna i det nya regelverket om medicintekniska produkter.
Key2Compliance® sitter med i flertalet Tekniska Kommittéer
Tekniska Kommittéer har i uppdrag att utarbeta, upphäva och revidera svensk standard och medverka i internationellt standardiseringsarbete. Läs mer om arbetet med framtidens standarder. Läs mer om SIS standardutveckling →
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: […]
Focalcube – A competent eQMS at an unbeatable price
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
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 […]