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I am working on completion of our Risk Management Procedures. Is FMEA required for Class I devices, or is there a simpler alternative we can use?
What are examples of Applicable regulatory requirements?
Does ISO 13485 cover code required electrical and fire approval such as UL or is this just medical approval?
1. Clinical evaluation - are we qualified to complete this ourselves? I have documented professional experience of >14 years but not a medical degree
2. MDR requires a suitably qualified person to act as the person responsible for regulatory affairs - is there any definition about what suitably qualified means?
With the combined package for ISO 13485 and MDR, do we need any external assistance with the technical file and clinical evaluation? i.e. a healthcare professional
1. What language requirements are there on the following in countries within EU?
2. Do you have a list on specific language requirements PER country on the above?
What is the biggest challenge when seeking compliance to the EU MDR?
Is there a list available with all the ISO Standards for medical devices and IVD’s?
I was looking for information regarding Mock recall in medical devices UK & EU under ISO 9001 & ISO 13485
As part of the ISO 13485, do we also need to comply with ISO 14971?