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ISO 13485
ISO 13485 :2016
About:
Stakeholders of medical device sector must meet quality and safety requirements. To guarantee the compliance of your medical devices with regulations, and to meet the expectations of your customers while enhancing your quality procedures, ISO 13485 is the ultimate solution.
The latest version of ISO13485 was published in 2016. It is based on the ISO 9001 standard with some additional requirements which are specific to medical devices, such as risk analysis, traceability, sterilization, testing and long term monitoring.
Eligibility:
ISO13485 certification mainly concerns companies that operate in the fields of design and manufacture of medical devices.The ISO 13485 certification standard can also be used in other industrial sectors, when a quality management system with additional requirements compared to an ISO 9001:2015 system, is needed.
Medical device (MD) means any instrument, device, equipment or even software intended, by its manufacturer, to be used in humans for medical purposes, in particular diagnosis, prevention, control, treatment, alleviation of disease or injury.
Advantages ?
- Recognition and opportunity to meet the needs of the international market
- Meeting legal and regulatory requirements
- Recognition of the certificate nationally and internationally and especially by other industrial fields
- Improved product’s safety and traceability management
- Manufacturing process controls improving quality and productivity
- Streamlining business processes and improving efficiency
- Better commercial performance and increased durability.
- International recognition for ISO 13485 certification
- Organization accredited on all branches of the ISO13485 standard
- Extensive experience in the field of ISO13485 certification in Europe and Eastern countries
- Auditors from the medical and health field, experts in the specific requirements of the standard and which makes you have exactly what you need.
- Very competitive costs and irreproachable responsiveness during the certification process
