ISO 13485:2016 is a management system for medical device.It ensures the consistent design, development, production, installation, and delivery of medical devices that are safe for their intended purpose.
Medical Device means any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software, material or other similar or related article:
Intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the specific purpose(s) of:
We need to know your industry, number of staff, number of locations and scope of certification
Conduct a Gap Analysis and interview with different Dept Rep.
Provide awareness training and advisory visit
Provide a consultant to attend the whole audit
The Fees depend on company size, number of locations, business nature and operation complexity.
For Company (Staff < 20), it take 4 months on average.
For Company (Staff ~50), it take 6 months on average.
For Company (Staff ~100), it take 7-9 months on average.
You may take below steps :
1) ISO 13485:2016 Gap Analysis.
2) Establishment of ISO 13485:2016 Documentation.
3) Attend ISO 13485:2016 Training.
4) Implementation of ISO 13485:2016 System.
5) Arrange an IISO 13485:2016 Internal Audit
6) External ISO 13485:2016 Audit by Certification Body
There are two major Fees.
1) ISO 13485:2016 Certification Fee charged by Accredited Certification Body such as SGS, Lloyd’s Register,BV, BSI, British Assessment, NQA…
2) Consultant Fee charged by us.
The Fees depend on company size, number of locations, business nature and operation complexity
Yes. You can take a series of training courses, draft the documentation…. liaise with Certification Body if you have sufficient time and master the ISO 13485:2016 requirements
No. Because of conflict of interest. Certification Body can provide ISO 13485:2016 Standard generic training only but cannot tell you how to implement ISO 13485:2016 System in your company.
Absolutely Yes. In general, ISO Consultant will draft documentation, guide your company to implement ISO 13485:2016 system until passing in ISO 13485:2016 Certification Audit.
In general, the company can put the ISO 13485:2016 logo in the website, name card and letterhead after receipt of corresponding ISO 13485:2016 Certificate
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