• Reviewed and enhanced several elements of a medical device quality system, including Materials, CAPA, Management Review, Design Controls and Production and Process Controls in team effort to prepare for third party QSR certification audit resulting in successful recommendation for certification and subsequent clearance of an FDA Warning Letter. - Recognition from the CEO: “Jim is a first rate medical device quality system expert…He was instrumental in our success in rebuilding our quality system and satisfying the FDA after a tough inspection in 2007.” Recognition from the Director of Materials: "Jim sets the bar for professionalism and thoroughness as a consultant. What I appreciated most was the collaborative approach he used in working with our department."• Contributed to Design Department effort during the Design Controls portion of an FDA audit resulting in no adverse findings for Design Controls. - Recognition from the VP of New Product Development: "Thanks for your support – you were a key to our success, particularly a) specific tactical work, b) the training and c) personal counsel to me.”• Trained employees in Quality Systems, FDA audit preparation, audit etiquette and removal and correction procedures.• Prepared in vitro diagnostic start up for ISO 13485/CMDR certification including quality system review and revision, internal audit execution and resolution, design controls implementation and administration and risk management execution. Audit resulted in recommendation for certification.- Recognition from the CEO: “Jim has been quite valuable as an adviser to the company regarding compliance with biomedical regulatory and quality standards associated with our In Vitro Diagnostic products.”- Recognition from the CSO: “Many thanks for your help in getting our regulatory efforts organized.”

• Submission of US 510(k) for Class 2 device resulting in device clearance.- Recognition from the FDA lead reviewer for doing a “fabulous job” on documenting the information in the submission.• Secured Health Canada Class 2 device clearance.• Prepared Technical Files for medical device and IVD manufacturers resulting in approval.• Provided audit and consulting services to an imaging/navigation start up contributing to ISO 13485 certification and FDA QSR audit with no findings. - Recognition from the QA/RA Manager: "I really appreciate all the assistance and advice you provided during your audit . . . it definitely helped with our last two successes!”• Prepared and guided an ISO 13485 certified design firm through the Notified Body audit process resulting in no adverse findings, one recommendation for improvement and three positive findings.• Led teams in Health Hazard Evaluations and provided guidance in hazard analyses. Team participation and guidance on risk management process review and improvement to comply with the requirements of ISO 14971.• Conducted risk management activity for a Class III device start-up to include coordination of and contribution to the risk management plan, failure mode effects analysis and risk management report. - Recognition from the Senior Director, RA/QA: “I think you’ve been doing a fantastic job. You’re my secret weapon on risk management…”• Coordinated Class I recall including strategy development, team leadership, communication with FDA and monitoring consignee follow-up.- Recognition from the Director of QA/RA: “…thanks sincerely for embracing the recall tasks as you have. You do excellent work.”• Developed and implemented an ISO 13485, CMDR and FDA QSR compliant Quality System for a Class II medical device start up resulting in ISO 13485/CMDCAS certification.• Audited medical device suppliers to applicable elements of ISO 13485, FDA QSR, CMDR and MDD.• Functioned as Management Representative for three clients.

Responsible for QS/RA for the design and manufacture of surgical navigation and intra-operative imaging devices. Responsibilities include assurance and regulatory function oversight of three facilities, acquisition due diligence and integration, documentation control, technical communications and global regulatory submissions and compliance including HIPAA, ISO, MDD, CMDR, PAL and FDA QSR.

Directed QA/RA efforts for a manufacturer of commercial and medical device products. Responsibilities included assurance and regulatory functions, customer and supplier interface, documentation control, ISO 9001:2000 certification and FDA QSR implementation.

Directed QA/RA efforts for a prosthetic device manufacturer including regulatory and assurance functions, customer/supplier interface, documentation control, ISO certification maintenance, sterilization validation, CE mark approval, FDA QS Regulation coordination, clinical research and PMA submission, and strategic planning facilitation.