ISO 13485 - QMS Medical Device Certification
                     ISO 13485 - QMS Medical 
Device Certification
Operon Strategist
What's ISO 13485 Quality Management System ?
How do you manage your Quality Management System? If you're like the majority of the medical 
device industry, chances are you have a QMS that's a combination of paper- based processes 
and general purpose tools, approximately held together by a group of people within your 
company-- generally document control. 
It’s important because it's long overdue with the former interpretation being released 13 years 
before in 2003. 
The 2016 standard is veritably much a bridge. What I mean is that this bridge explicitly describes 
and defines current QMS prospects for medical device companies. Prior to these advances being 
formally defined and documented in the standard, numerous of the best practices being advised 
and adopted were veritably ad hoc in nature and frequently sounded to be based on auditor 
opinions.
Medical device manufacturer should appoint an experienced ISO13485 consultant who 
can work on all risk class devices. The associations need to cover the safety and risk 
information during product life cycle as per ISO 13485 demand. As an ISO 13485 medical 
device consultant, Operon Strategist identify the specific regulatory demand for the product 
similar as MDR, FDA 510( k) during the perpetration. This helps manufacturer in the further 
process of CE mark medical device or FDA 510( k) clearance.
Key elements of an ISO 13485 Quality Policy:
● Adapt the policy to the association. 
● Define a frame for setting your quality objects. 
● Establish the commitment to meeting all conditions. 
● Establish the operation commitment. 
● Communicate the Quality Policy. 
● insure the regular review of the Quality Policy.
Operon Strategist
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