Free ISO 13485 Work Environment SOP Template
Free Template You can buy the ISO 13485 standard here. Email us here to get and type CMSworkenvironment in the email message to get our “Free ISO 13485 Work Environment SOP Template” if…
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…
CMS New Office!
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…
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. …
Free ISO 13485 Management Review Template
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?
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…
Free ISO 13485 Training Procedure Template
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…
