A Mark of Quality: ISO 13485 for Medical Device Design

Our achievement of ISO 13485 accreditation means we can deliver medical device design projects with consistent quality. It is a significant milestone in Tool’s medical device design journey. This certification is not just a badge of honor; it reflects our systemic approach to design, development, and prototyping of medical devices. It underscores our commitment to quality management and regulatory compliance.

ISO 13485 is the most widely accepted standard for quality management for medical devices.

For Tool, the quality management system means we have defined processes for each stage of a medical device project. For example, pre-project communications, resource planning, internal approvals, client presentations, vendor qualifications, regulatory standards and associated testing, prototyping, engineering. 

ISO:13485 quality management system for medical device design and prototyping

So, this medical device quality management accreditation supports Tool’s ability to innovate to truly make a difference in people’s lives. It assures our clients of our dedication to excellence and our competence in navigating the complex landscape of medical device regulation.

If you are interested in learning more get in touch. We would love to show you our approach to setting quality standards. More importantly, we can discuss how each project must work with those standards. Ultimately, Tool is here to deliver innovation which complies with safety, robustness and meets every regulatory standard you need.

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