How to do Biological Evaluation
How to do Biological Evaluation (according to ISO 10993-1: 2009) This is how biological evaluation was performed previously: Identify device contact nature Identify contact time Performed test as indicated in…
How to do PMS
How to do PMS (Introduction) Now with the introduction of EU MDR, there are suddenly a ton of new information that you need to be familiarize with to comply to…
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 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…
