Precision. Compliance. Performance.
Strategic consulting services for your entire medical device lifecycle.
Precision: Engineering Rigor & Technical Strategy
Ensuring the integrity and technical excellence of your medical devices from concept to market.
- Systems Technical Strategy: Defining robust, compliant roadmaps for hardware and software systems, ensuring seamless integration across the entire product lifecycle and reduced overall risk.
- R&D Design Control: Developing processes that ensure end to end traceability and risk management including integration of supplier management in early phases of development.
- Reliability Engineering & Performance Verification: Supporting your reliability and verification / validation testing with protocol development and results and documentation reviews to verify system performance and validate design changes for both development and on-market products.
- Technology & Design Transfer: Develop roadmaps for complex transfer of technology from R&D or third-party developers into formal, audit-ready quality systems and / or third-party manufacturers.
Compliance: Regulatory Alignment & Risk Mitigation
Navigating FDA and ISO 13485 requirements with proactive, risk-based quality assessments and solutions.
- Global QMS Implementation: Gap assessment and support for development and updates for scalable Quality Management Systems specifically tailored to regulatory demands of medical devices.
- Supplier Quality & Purchasing Controls: Optimize your supply chain with our risk-based classification programs, comprehensive supplier audits and performance metrics development.
- Quality Documentation and Auditing: Ensuring documentation is audit ready; providing pre-audit assessments, support during, and post audit actions.
- Risk Management: Ensuring risk management frameworks support your products meet evolving global standards during development and in post-production
- CAPA & Technical Investigation: Provide external expert oversight and support for on market performance issues including: complaints, root cause investigations and corrective actions, ensuring your products maintain sustained compliance and market safety
Performance: Operational Excellence & Service Optimization
Optimizing operational infrastructure and talent to drive down costs and improve global service delivery
- Global Service Operations Strategy: Optimizing operational infrastructure to support rapid market growth.
- Supply Chain & TPM Management: Optimize supplier vendor performance through strategies designed to mitigate risks and improve high quality deliveries.
- Operational Optimization: LEAN / Six Sigma tools used to boost operational efficiency.
- Strategic Cost Reduction: Develop roadmaps for actionable strategies for material system cost reductions and long-term savings in spare parts and servicing costs.
- Organization Design & Talent Strategy: Expert vetting to ensure your team is built with the precise proficiency required for high-stakes medical devices.
Why Choose Us?
"Corporate Standard" of Excellence
With over 30 years of experience at a global leader in diagnostics, I can bring "big-medtech" rigor to companies of all sizes.
Full Lifecycle Mastery
I have hands-on experience across the entire continuum—from early-stage R&D and design control, design transfer, manufacturing and post-market support and services.
Proven Financial Impact
My strategies aren't just theoretical. I have a track record of supporting large scale budget solutions and identifying cost reductions in complex system designs or service activities.
Compliance Without Friction
I navigate the complexities of FDA and ISO 13485 regulations by integrating quality into the design process, not treating it as a hurdle at the end.