EU Authorised Representative
In which cases do you need to assign the EU Authorised Representative for Medical Devices? Read further to know more about this subject. Certification Company – Your reliable EU Authorised Representative…
EU Medical Device Regulations
What is EU-MDR compliance? The European Medical Device Regulation (MDR) is a set of regulations that governs the production and distribution of medical devices in Europe, and compliance with the…
Common Specifications
CS Links Commission Implementing Regulation (EU) 2020/1207 of 19 August 2020 laying down rules for the application of Regulation (EU) 2017/745 of the European Parliament and of the Council as…
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…
Medical Device Registration in Europe
Medical Device registration in Europe or EU (Entire CE Marking process) https://youtu.be/jPcKVR7liMg Please click here the European commission medical device website and for more information on medical device registration in Europe. …
When to implement UDI?
When to implement UDI? For CE Eventually all Medical Device entering EU markets under than custom made and performance studies/ investigational devices. Most of the time the question is when…
Class I reusable compliance to EU MDR
Class I reusable compliance to EU MDR: Introduction We should all by now know that class I reusable device is a new category introduced by EU MDR. (click here to…
How to choose a PRRC
How to choose a PRRC (background) To comply with Regulation (EU) 2017/745 (more commonly known as EU MDR), one of the earliest step that the manufacturer should consider is to…
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…
