My solo consultancy is geared towards startup medical device companies preparing for quality system lift-off. The focus of my work is to deliver customized, world-compliant, lean, paperless quality system document sets based on what I have learned in my 35+ year career.
After day-jobs at 7 firms for 26 years, I transitioned to full-time consulting in 2009. Since then, I have helped over 60 medical device firms set up or renovate their quality systems. I offer a "Full Document Set" that covers all life-cycle stages and a "Startup-Pack Document Set”. The Startup-Pack includes procedures needed for product development work to support initial regulatory authority submissions but does not include procedures needed to support device human clinical investigation or commercialization.
My tailored document sets provide a solid foundation for quality system implementation, whether starting from scratch (preferred) or renovating an existing system (ugh).
After delivering the document sets for a fixed price, I provide consulting services for strategic advice, implementation support, regulatory requirements training, internal quality audits, and independent design reviews (required by the USA FDA).
Caution: I do not have the bandwidth to run my clients' quality systems. The client will need to appoint a Quality System Management Representative and functional group managers (R&D, QA, RA, Marketing, Operations, etc.) who use the system to guide their activities, combined with their own experience, common sense and technical/business decision-making skills. As a consultant, I will coach and mentor team members as desired.
For more information about my work, my opinions, and my services, please visit
MDQC.com
My resume, including my client listing, is attached.
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