ISO 13485:2003 – Medical Devices

The ISO 13485:2003 Standard relates to quality management systems in the field of Medical Devices, including IVD (In Vitro Diagnostic). The standard can be used by an organization for the design, development, production, installation and servicing of medical devices as well as for the design, development and provision of related services.

How can we help?

We provide a number of services which will help you to make a smooth transition from your current management system to a fully certified, ISO 13485:2003 quality management system.  In order to best match your individual requirements, our support can be tailored in such a way to suit the nature and size of your organization, and your current status in terms of quality management system development. The support we provide can be scaled from the minimum level e.g. coaching and training, right up to maximum support, where we provide full project management, with system administration as an optional extra.

Please click on the links below for further information

• Document Compliance Review
• Pre-Assessment Audit
• Internal Audit
• Project Management
• Coaching and Training