ISO 13485 (Medical Devices)

ISO 13485 (Medical Devices)

The ISO 13485 standard is an effective solution to meet the comprehensive requirements for a QMS. Adopting ISO 13485 provides a practical foundation for manufacturers to address the medical device directives, regulations and responsibilities as well as demonstrating a commitment to the safety and quality of medical devices.

ISO 13485 was written to support medical device manufacturers in designing quality management systems that establish and maintain the effectiveness of their processes. It ensures the consistent design, development, production, installation, and delivery of medical devices that are safe for their intended purpose.

What are the benefits of ISO 13485?

Whether you are looking to operate internationally or expand locally, ISO 13485 Certification can help you improve overall performance, eliminate uncertainty, and widen market opportunities. Companies with this certification communicate a commitment to quality to both customers and regulators.

Increase access to more markets worldwide with certification
Outline how to review and improve processes across your organization
Increase efficiency, cut costs and monitor supply chain performance
Demonstrate that you produce safer and more effective medical devices
Meet regulatory requirements and customer expectations

Why choose QMSCI

Our qualified auditors independently evaluate the supplier to ensure the required standard, policies and procedure to be followed by them. To make sure that the supplier’s production control, manufacturing processes are according to the globally accepted Standards.

We are offering:

Easy online scheduling of services
Response within 48 business hours.
All-inclusive pricing
·Necessary Reporting