Easy Guide on how to comply to MDR and ISO 13485
Introduction: Easy Guide on how to comply to MDR and ISO 13485 "Easy Guide on how to comply to MDR and ISO 13485" is aimed to provide first the…
How to choose an EC REP
How to choose an EC REP This article on how to choose an EC REP applies to Authorized Representative, Sponsor or Consultant too. Please click here to access the European commission…
How to do Clinical Evaluation Report
How to do Clinical Evaluation Report: MDCG 2020-13 One way to ensure that your CER is complying to CE requirements is to ensure that that your CER contain all the…
EU DOC complying to EU MDR
EU DOC complying to EU MDR The below is extracted from EU MDR. Using surgical mask as an example, please see below how we can draft the EU DOC complying…
EU MDD to MDR
EU MDD to MDR Frequent made mistakes Frequent mistakes when transiting from EU MDD to MDR Did not include UDI in EC DOC Did not include the reference to OTHER…
EU MDR official website
EU MDR official website There are so many articles that advise on CE MDR/ IVDR regulations implementation that most of the time, people get lost trying to find the latest…
EU MDR Technical Documentation
EU MDR Technical Documentation Updated: 19th July 2020 Please see below for example or explanation for EU MDR Technical Documentation. ANNEX II TECHNICAL DOCUMENTATION The technical documentation and, if applicable,…
How to fill up GSPR
How to fill up GSPR Updated: 19th July2020 How to fill up GSPR: GSPRDescriptionApplicable?Method appliedStandards and SolutionsEvidence7Devices shall be designed , manufactured and packaged in such a way that their…
EU MDR Class I Medical Device
EU MDR Class I Medical Device Updated: 19th July 2020 We have work with clients on CE MDR process for Class I non-sterile, non-measuring, non-reusable. What this means that Manufacturers…
