Keystone Regulatory Services offers a broad range of consulting services for the medical device industry. Follow the links below (or on the right hand side of the page) for more detailed information regarding our practical approach to your regulatory affairs and quality system needs.
Quality Management System Consulting
- ISO 13485:2003 Transition
- ISO 13485:2003 Training
- Quality Management System Gap Analysis
- Quality Management System Development / Optimization
- Implementing Quality Management Systems in "Virtual" Companies (Companies relying heavily on outsourcing services.)
- cGMP (21 CFR Part 820)
Risk Management Consulting
- ISO 14971:2000 Transitioning
- ISO 14971:2000 Training
- Risk Analysis / Risk Management
- Integrating Risk Management with Quality Systems
Quality Management System Auditing
- Supplier Auditing
- QMS Auditing
- QS Gap Analysis
- Auditor Training to the Process Approach
Premarket Regulatory Strategy and Support
- Market Entry Strategy
- Design Verification and Validation Testing Input and Oversight
- 510(k) / IDE / PMA
- CE Marking / Technical File / Design Dossier Preparation
- Combination Products
- Medical Device Development Project Management
- Clinical Studies
- CMD CAS Registration
- International Product Registrations
Postmarket Compliance
- MDR Support
- Advertising and Promotion
Dispute Resolution
- 483, Warning Letter, Untitled Letter Response Strategy
- Audit Nonconformance Response Strategy
Other Services
- Expert Witness
- US Agent for Medical Devices
- Contract Regulatory Officer
- Acquisition Due Diligence