ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services.
It is applicable to manufacturers of medical devices and to those organisations that support medical device manufacturers. Manufacturers have a duty to ensure that devices consistently meet customer requirements and meet all applicable regulatory requirements.
The international quality management system (QMS) standard for medical devices, ISO 13485:2016 (Medical Devices – Quality management systems – Requirements for regulatory purposes) and the European Standard version, EN ISO 13485:2016, were published on 1 March 2016.
Benefits of ISO 13485 Certification
- Global Recognition
- Improved legal and regulatory or contractual requirements compliance
- Assistance in monitoring supply chain effectiveness
- Increased profit margins
- Improved product safety
- Increased Efficiency
- Proactive error detection and prevention
- Cost Savings
- More Effective Risk Management
- Increased likelihood of meeting Customer Requirements
- Safe and effective medical devices
- Lower skepticism and increased confidence for end-customer
4 Simple Steps To Get Certified!
Fill the Application Form to apply for the certification.
We will train your staff and certify as an Internal Auditor for continual improvement of your company.
Audit Guaranteed Success! We will provide assistance during final certification audit to ensure that your organization achieves certification successfully.
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