Quality engineering
We ensure Team’s Quality Management System (QMS) is aligned with your own throughout the life cycle of your project, maintaining compliance with the relevant regulations (ISO13485:2016, 21CFR Part 820).
We ensure Team’s Quality Management System (QMS) is aligned with your own throughout the life cycle of your project, maintaining compliance with the relevant regulations (ISO13485:2016, 21CFR Part 820).
Our quality engineering consultants will support your development from proof of principle to launch, or even at the proposal stage if required.
We ensure all project documentation is in compliance with the quality and regulatory requirements of your medical device project, liaising directly with your quality engineering and manufacturing partners to achieve this.
Our QMS has the flexibility to accommodate your specific requirements and integrate with your own QMS while maintaining regulatory compliance.
Need help creating key documentation for a technical file or Design History File (DHF) for your medical device? We offer advice on key documentation throughout your project with us or as a standalone service.
We support your medical device development project in the following ways: