Do you need extra resources to implement and manage design controls for your medical device or combination product?
In today’s world of complex medical device products and ever-changing regulatory requirements, specialized design control resources are invaluable to ensure your medical device is in compliance and designed right the first time.
We specialize in design control solutions that satisfy the requirements of ISO 13485 and FDA CFR 21 Part 820.30; we have expertise with the following deliverables:
- Design and Development Plan
- User Needs and Stakeholder Needs
- Design Inputs
- Design Outputs
- Design Verification
- Design Validation
- Design Reviews
- Trace Matrix
- Design Transfer