Regulatory Services

Quality Management System Certifications for Medical Devices

Quality Management System Certifications can be used to monitor and continually improve the quality of your products and services.

Medical device manufacturing is one of the most regulated sectors in which significant quality systems and product requirements must be satisfied.

The regulatory requirements are intended to ensure that manufacturers consistently design, produce and place onto the market medical devices that are safe and fit for their intended purpose.

We offer a wide range of proven regulatory and quality management programs that work together for full international compliance.

Demonstrate your ability to provide safe medical devices and services that consistently meet customer demands and applicable regulatory requirements.

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Through MDSAP, medical device manufacturers need only to be audited once in order to comply with the standard and regulatory requirements of up to five different medical device markets.

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In the medical device industry, risk management goes beyond product development and manufacturing; it forms a vital aspect of the lifecycle of your product. ISO 14971:2019 defines the international requirements of risk management systems for medical devices, defining best practices throughout the entire lifecycle of a device.

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EN 60601 is a group of standards equivalent to the international series of standards IEC 60601 and comprises over 70 individual standards.

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