What is ISO 13485:2016
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:
a) Intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the specific purpose(s) of:
- diagnosis, prevention, monitoring, treatment or alleviation of disease,
- diagnosis, monitoring, treatment, alleviation of or compensation for an injury
investigation, replacement, modification or support of the anatomy or of a physiological process,
- supporting or sustaining life
- control of conception
- disinfection of medical devices
- providing information for medical or diagnostic purposes by means of in-vitro examination of specimens derived from the human body;
- and which does not achieve its primary intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its intended function by such means.
Benefit of ISO 13485:2016
- ISO13485: 2016 certification can help to expand global market access
- Assist companies to improve their processes
- Improve efficiency, cut costs and monitor supply chain performance
- Explain the production of safer and more effective medical devices
- Meet regulatory requirements and customer expectations
What is it for ISO 13485:2016 ?
- Comply with Contract requirement
- Enhance compliance of relevant regulation
- Give Customer more confidence
Looking for a helpful ISO 13485:2016 Consultant?
Partial Client List
Frequent Asked Question
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