ISO 13485 Medical Devices Standard

No doubt this is a niche requirement but Strident's Compliance Specialist, Rebecca Richards, is fully qualified to implement the ISO13485 Medical Devices Standard.

"We are committed to providing a comprehensive range of compliance services to our customers," explains Rebecca. "By gaining this qualification, we were able to help a long-standing customer and it demonstrates how our compliance expertise can be extended when possible."

What does the ISO 13485 Medical Devices Standard cover?

ISO 13485 covers regulatory requirements for medical device quality management systems. It is the foundation for the development, production, installation and delivery of products that are safe for their intended purpose including:

• Designing medical devices
• Maintaining, testing or repairing devices
• Using medical devices
• Cleaning medical devices

Who is this standard aimed at?

Organisations can include medical device designers and manufacturers, private and public medical service providers (diagnostics, treatment, general), occupational health providers, maintenance and repair services, calibration services and medical grade cleaning services.

Strident can help business obtain and retain a wide range of ISO standards. To find out more, then please get in touch here.