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Medical Products Consulting & Contracting Services

I work with established medical products companies and companies that are new to the space to implement and optimize their quality management systems (QMS) to best fit their business.  My level-headed approach involves honest, open interactions with the FDA and ISO registrars in any circumstance.

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Medical Products Consulting & Contracting Services

  • ISO 13485:2016 and FDA (21 CFR 820) Quality System Development (companies new to medical product space)

  • Implementation of Design Controls for technical teams

  • Training to various elements of FDA Design Controls and ISO 13485:2016 for technical teams and executives

  • International registrations/certifications of medical products with FDA and/or CE Mark

Quality Systems Optimization

  • Conversion of QMS to cloud-based solution

  • Audit/ inspection planning and execution

  • Optimization of QMS to better align with business processes

  • Alignment of IEC 62304 to ISO 13485 Design Controls

  • Risk Analysis including conversion of procedures to 14971:2019

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Mitigations and Troubleshooting

  • Root cause analysis

  • Recall/complaint investigation and management

  • Audit/inspection response management

  • FDA response advisory

Services : Services
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