JOHN C. HOFFMAN

Manging Director

Creative and responsible professional with extensive worldwide V.P./Director level experience. Expertise in quality assurance and management and medical device regulatory affairs. Other areas of proficiency include all FDA regulations, ISO 9000/13485 international quality standards, sterilization, product safety and liability, SEI Capability Maturity Model, and client satisfaction. Expertise in a wide range of products, including IVD, biologicals, pharmaceuticals, software, instrumentation, electronics and disposables. Effectively implemented and maintained compliance with regulations and standards through training and awareness initiatives. Utilized team building programs and strong working relations with the FDA and standards and industry associations.

SKILLS & SPECIAL QUALIFICATIONS

• Thirty years of Medical Device, Pharmaceutical and Biologics Quality and Regulatory experience, including twenty years at the Director/Vice President level and over eight years in consulting.
• Experienced in start-ups and re-engineering quality systems.
• Twenty years experience in medical software and information systems, including Medical Device Data Systems (MDDS), IEC-80001, HIPPA, GxP software, process control systems and software products regulated by the FDA. Expertise in all phases of the software development life-cycle, design controls, hazard analysis, validation, installation, support and PMAA, 510(k), pre-IDE and de novo submissions.
• Extensive, broad knowledge of US FDA quality & regulatory body regulations.

ACCOMPLISHMENTS

• Established or re-engineered Good Manufacturing Practices/Quality Systems Regulations programs at several medical device manufacturers, with no major compliance deviations found on subsequent inspections.
• Reversed serious FDA compliance problems and avoided potential legal sanctions for multi-facility international manufacturer of sterile disposables and reusable items. 
• Reduced the number of software product safety defects delivered to clients by 75% in one year through implementing proactive safety awareness, design hazard analysis and process improvement programs.
• Achieved 50% reduction in healthcare informatics software development cycle time while reducing delivered defects by 30% through implementation of SEI CMM. Improved SEI CMM indicators from level 1 to level 3 in a two year time frame.
• Increased client satisfaction levels in all categories by over 25% over a two year period through implementation of Motorola quality initiatives.
• Significantly reduced costs and cycle time while improving quality of both ethylene oxide and radiation sterilization processes through cycle and process re-engineering and packaging improvements.
• Developed software 510(k) submission that was "the best" the FDA reviewer had ever seen.

TRAINING
FDA, Johnson & Johnson, Motorola, Trade Associations - Ongoing seminars on FDA regulations, QSR, QSIT, GxP, HIPAA, risk management, document and change control management, international standards, product safety/liability, software process (SEI, IEEE), quality management, Six Sigma, process mapping, electronic data/signatures (21CFR11), team building, leadership and sterilization.

PROFESSIONAL AFFILIATIONS
AAMI, ASQA, RAPS, AABB, AdvaMed, CHIMS, HIMMS, WEDI, Center for Software Excellence (Director 1992-95), Florida Medical Device Association (Director 1984-85), Arizona Quality Alliance, Arizona Software Association, Arizona Bioindustry Association (Chair AZBio Resource Network 2011), Bioindustry Organization of Southern Arizona.

AWARDS AND HONORS
Special Commissioner’s Citation – FDA – 1997
Leadership Award – Center for Software Excellence - 1994

EDUCATION
B.A. in Economics, Northwestern University - 1974
Certified ISO 9000 Lead Auditor - 1995
AAMI Certificate of Achievement - GMP Requirements and Industry Practice - 1997
AAMI Certificate of Achievement - Design Controls - 2006