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ISO 13485 certification advantages when I certify a Class 2a medical device

ScottK

ScottK

Not out of the crisis
Staff member
Super Moderator
#11
#11
It appears that according to the directive you do not NEED to be registered to ISO 13485 for a class IIa device.

However - I'm certain you will need some sot of Quality Management System to meet the minimum requirements of the directives (like document control, record control, change control, etc). If you have these you probably don't NEED ISO 13485 registration.

If you do pursue ISO 13485 registration one benefit would be that you have a proven system in place for future Class IIa registrations and you may be able to skip the Examination and Testing by the notified body and just have them approve your QMS via ISO 13485 registration.

Are you selling your device direct to market? If not, if you are a supplier to other medical device companies, they will likely expect that you have ISO 13485 registration. I've been in the class I world and that's an expectation. If you don't have it then they'll look to competition.
 
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KarrenMill

#12
#12
bwin001 said:
What advantages does ISO 13485 certification give me when I certify a Class 2a product?
thank you:bigwave:
Click to expand...
If you are medical device company and you want to sell your device in Europe, ISO 13485 certification is required, it is a step closer to getting CE Mark approval.
Beside this, advantages of ISO 13485 certification are:
Reduce errors, paperwork, QMS reports, cost, prevents mistakes and ensures that processes are defined and controlled.

It improves organization and has a direct impact on your product. :)
Hope this helps!
 
V

Vaishnavi

#13
#13
Hello,

ISO 13485 approval gives your product and facility run under the standard quality system(QMS). It compliance the regulatory requirement of the product and facility.
 
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