Quality engineering
We ensure Team Consulting’s Quality Management System (QMS) is aligned to your own throughout the life cycle of your project, maintaining compliance with the relevant regulations (ISO13485:2016, 21CFR Part 820).
Quality in every project
Our quality engineering team support your development from proof of principle to launch, or even at the proposal stage if required.
Compliance at the heart of everything we do
We ensure all project documentation is in compliance with the quality and regulatory requirements of your project, liaising directly with your quality engineering and manufacturing partners to achieve this.
Flexibility to meet your needs
Our QMS has the flexibility to accommodate your specific requirements and integrate with your own QMS, while maintaining regulatory compliance.
Compiling your technical and Design History File
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.
Our capabilities
We support your development project in the following ways:
- Identifying your quality needs at the proposal stage
- Integrating Team’s QMS with your QMS, including the creation of project-specific procedures
- Independently approving project documentation used to support regulatory approval
- Generating planning documents – D&D Plan, Risk Management Plan (RMP), Human Factors Engineering Plan (HFEP)
- Compiling your Technical File and DHF
Transfer of project documentation - Key documentation advice throughout your project with us or as a standalone service
