Use of Harmonised Standards The MDCG 2021-5 Guidance on standardisation for medical devices explains the use of harmonised standards for demonstrating compliance to MDR (EU...
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The new date of application of MDR is 26 May 2021. If you plan to CE Mark your medical device or prepare for MDR transition, this “How to?” article maybe useful for you…
Premarket notification process, known as a 510 K submission, is required for Class II devices to enter the US Medical Device Market…
This 2016 revision of the standard provides a basis for the quality management system in parallel to the EU MDR and other international regulatory changes…
The implementation of the ISO 14971 standard by the manufacturer is the most appropriate solution to ensure the requirements for risk management…
The Number of Medical Device Notified Bodies is increasing
Last week EU Commission has announced EU MDR 2017/745 designation of Eurofins Expert Services Oy located in Finland as the 20th notified body (NB). But considering...
Read MoreFDA Biocompatibility Assessment Resource Center
FDA issued a new page called “Biocompatibility Assessment Resource Center”, where you can find useful information for your biocompatibility evaluation. The web pages mainly include...
Read MoreEUDAMED Single Registration Number
The first module of the EUDAMED (European Databank on Medical Devices ) is live as of 1st December of 2020. This will enable economic operators...
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Medical Device Software Life Cycle Management
The increased validation requirements of MDR (EU 2017/745) bring new...
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EU Medical Device Regulation – How to CE Mark a Medical Device ?
CE mark is required for each medical device sold in...
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MDR Clinical Evaluation Requirements
MDR Clinical Evaluation Requirements including clinical investigation are defined on...
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US FDA 510 K Submission – How to prepare a 510 K File?
Food and Drug Administration (FDA) is the legal authority to...
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