We understand that Quality Systems and practices are paramount in Medical Device Development and ultimately medical regulatory compliance. That’s why all the work we do adheres to stringent guidelines.
ISO 14971 standard
Trust The Experts in Medical Device Risk Management following the ISO 14971 Standard
Good Manufacturing Practices (GMP)
Be in Compliance with the FD&C Act‘s Good Manufacturing Practices
ISO 13485 standard and Quality System Regulation (QSR) 21 CFR 820
Trust The Experts in Quality System Implementation and Review
Our Services Include
- Solving manufacturing system problems in a GMP compliant manner
- Medical Device Development or validation of any of your manufacturing systems
- Consulting to help streamline workflows of your Quality System
- Quality System Review and Gap Analysis
- Develop and Implement a remediation plan
- Complete Quality System development
- The understanding of International Standards as they apply to medical devices.
- Development and execution of a plan to CE mark your products.
- Learn more about ISO 14971.