We’re a collaborative consulting company that will right size solutions for the size and complexity of your medical device business.
Quality System
Q.S. Development and Refinement
Internal Audit: Let a certified auditor give you confidence
3rd Party Audit Support
CAPA & Audit Remediation
MDSAP and MDR Implementation
Supplier Development
Supplier Audit
Component Capability & Control
Business & Quality Agreement Development
Project Management
Quality professionals with PM training will accelerate your project with the most efficient and compliant path forward.
Learn how we can right size your efforts and balance project risks.
Regulatory Support
Asking the right questions to ensure regulatory success
Complaint submission and response
Device Submission Support
Recall submission, monitoring, and closeout
Partnered Quality and Regulatory Consulting 