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…
CMS New Office! To ensure we meet our customers requirements, CMS and CMS SciDoc have a new facility with more resources. Our team is growing and our new office is…
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By cmsmedtechOctober 26, 2020Posted inCE
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. …
Free ISO 13485 Management Review Template You can buy the ISO 13485 standard here. Email us here to get and type CMSmangementreview in the email message to get our “Free ISO 13485 Management…
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…
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By cmsmedtechOctober 21, 2020Posted inCE
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…
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By cmsmedtechOctober 20, 2020Posted inCE
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…
Free ISO 13485 Training Procedure Template Free ISO 13485 Training Procedure Template Email us here to get and type CMStraining in the email message to get our “Free ISO 13485 Training…
Medical Device Registration in UAE: Classification Requirements 1. Certificate from Country of Origin (Free Sale Certificate/CE/ISO) (No need to be legalized and FSC not to be issued from Chamber of…
Medical Device Registration in Saudi Arabia Click here to visit SFDA (Authority) website to learn more on medical device registration in Saudi Arabia. Labels to show the following: 1. The…