Medical Device Quality Consulting
While 100% quality compliance should be part of any successful medical device company’s quality objectives, achieving this state is often filled with complex challenges. Overcoming these challenges may require additional resources or a specific set of expertise that is not within the core competencies of your existing resources. Our medical device quality consulting services can help bridge the gap in expertise or add additional support to already strained resources.
Medical Device Quality Consulting Services
- Quality & Regulatory Compliance
- Product Development Support
- Design Control
- Risk Management
- Process Validation
- Supplier Quality Support
- Post-production Support
- Quality Engineering Support
The quality and regulatory compliance landscape can be difficult to navigate and where multiple options exist our medical device quality consulting services put our medical device industry experience to work for you to develop a risk-based compliance strategy to keep your organization on track with its goals.
Whether you need readiness support for an upcoming audit/inspection or to address nonconformances as part of a remediation effort our medical device quality consulting services are here to help.
Quality & Regulatory Compliance Support
- Quality Management System (QMS) Strategy & Planning
- Quality Objective & Goal Setting
- Quality Plan Development & Implementation Support
- Quality Management System (QMS) Implementation and Maintenance
- Readiness Assessments
- Gap Assessments
- Remediation Strategy & Implementation Support
Product Development Design Control & Risk Management Support
- Design History File (DHF) Development & Documentation
- Risk Management File (RMF) Creation and Updates
- Customer Requirements Translation to Design Inputs
- Design Specification Development
- Design Verification & Validation (V&V) Protocol and Report Writing/Review
- Design Review Support (Independent Reviewer)
- Marketing Claim Review
- Inspection Plan Development
Process Validation (IQ/OQ/PQ) Protocol and Report Writing/Review
- Injection Molding
- Manual Assembly
- Automated Assembly
- Sterilization
- Retrospective Validation
Supplier Quality Support
- Supplier Evaluation and Monitoring
- Supplier Scorecard Development
- Supplier Quality Problem Resolution Support (SCAR)
Post-production Services
- Regulatory Impact Change Assessments
- Complaint Processing Development/Improvement
- Medical Device Adverse Event Reporting Decision Support
- Measurement, Analysis and Improvement of QMS
- CAPA Planning and Implementation
- Periodic Risk Management File Updates
GET FREE MEDICAL DEVICE QUALITY CONSULTING
Principal Consultant / Founder
For over 20 years, Scott has worked as a quality and regulatory professional within the medical device industry for manufacturers of Class I, II, and III medical devices. He is a hands-on technician who keeps the bigger picture of the total product lifecycle and business success top of mind. His goal is to provide clients with compliance options that fit the needs of their organization to enable business success.
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We help medical device companies build and maintain the right-sized quality management system.
Quality Regulatory Specialists
Why Choose Us?
Passion & Commitment
Honesty & Openness
Practical Approach
