QMS documentation of Medical Devices.
Any regulatory system always insists for written instruction for how to carry out any processes and needs written verifiable data in written form. This does not mean that it must be in hard copy mode. Digital mode is also acceptable provided it satisfy control, safety, and integrity requirements. One of the biggest advantages of written documentation is that everyone follows the same system and shares the data universally which can be utilised for betterment of patients and users like medical professionals and others. What is needed in QMS for medical device ? Detailed list will be very long but let us try to cover essentials of what is described in ISO, US FDA, EU regulatory guidelines. Scope of this blog is that what area are essential to cover and very very essential to cover in that area. Let s take some references which will be essential to refer for this. ISO 13485 –2016, US FDA 510k submission guideline, EU MDR guideline replacing old M...