Gary Turner has over 40 years of medical device regulatory and quality experience. He has successfully led Quality and Regulatory Affairs functions for medical device companies manufacturing Class I, II, and III devices.
Gary’s product experience spans:
- electro-mechanical devices
- orthopedic/spine implants
- digital and film x-ray imaging devices
- biologic devices
- human tissue products
- software-based devices
- devices incorporating firmware
- commercial/consumer products
He has successfully created Quality Management Systems for start-up companies and has taken mature Quality Management Systems to new levels for middle-sized and large companies, including Fortune 500 companies. He has led and maintained the certification of a number of companies to ISO13485, ISO9001, and ISO17025. He has successfully led the initial and ongoing compliance of companies with 21CFR Parts 806, 807, 820, and 1271, as well as the EU Medical Devices Directive and other EU Directive requirements related to medical devices.
In addition, he has extensive knowledge and experience in:
- global supply chain management, particularly in Europe and Asia
- lean manufacturing
- six sigma methods
He has successfully mitigated and responded to FDA Warning Letters and 483 Observations and has successfully led the recall of a number of products from distribution, both in the US and in the EU.
Gary currently holds the following certifications:
- Quality Engineer from the American Society for Quality
- Quality Auditor from the American Society for Quality
- Regulatory Affairs Certificate (US) from the Regulatory Affairs Professional Society
Lori A Carr is a former FDA Medical Device Specialist Field Investigator for the Denver and Cincinnati District Offices and spent 13 years with the Agency. Since 2007, when she left the FDA, she has been consulting with numerous medical device companies to help them comply with FDA regulatory requirements. She has extensive experience in and has delivered outstanding results for clients in:
- Auditing medical device manufacturers’ Quality Management Systems (QMS) to help ensure their compliance with applicable FDA regulations, including routine Good Manufacturing Practices (GMP), Pre-market (PMA), 510(k), and directed inspections from the Center of Devices and Radiological Health (CDRH);
- Planning and executing corrective action plans for FDA Warning Letters and FDA-483, Inspectional Observations, findings coming from FDA Quality System Inspection Technique (QSIT) and other inspections by the FDA;
- Conducting mock FDA QSIT to help prepare for anticipated FDA inspections; and
- Defining, documenting, and implementing Quality Management Systems ,which comply with applicable FDA regulatory requirements for start-up companies.
Lori holds current Regulatory Professional certifications in following:
- Regulatory Affairs Certification for United States (RAC/US) from the Regulatory Affairs Professional Society (RAPS);
- Certified Quality Auditor (CQA) from the American Society for Quality (ASQ); and
- Certified Principal Auditor for ISO13485:2003 (RABQSA) from QSA International ASQ Management Systems, Inc. (Exemplar Global).
During her time with the FDA, she was:
- Level II Certified FDA Medical Device Investigator;
- FDA Medical Device Performance Auditor, who audits other FDA Medical Device Investigators for proficiency; and
- Lead FDA Investigator on medical device Warning Letter and Injunction recommendations.
A highly capable educator, Lori:
- Trained FDA Investigators on FDA Basic Medical Device requirements;
- Assisted in developing QSIT training for Colorado State Inspectors and FDA Investigators;
- Conducts specialized Quality Management System topics to medical device and industry clients needing additional training in focused areas;
- Educated Industry, including the Colorado BioScience Association (CBSA) on FDA regulatory requirements; and
- Was an Adjunct Professor at Colorado State University, College of Biomedical Engineering in the Regulatory Affairs Certificate Program, instructing in the FDA Quality System Regulation (21 CFR Part 820) and ISO 13485:2003.
Joel Batts is 20 year veteran in the scientific, regulatory and business development spheres of medical devices. He has achieved over $50 million return on investment through a combination of rolling up his sleeves, simplifying the technical and building trusting relationships with physicians, regulatory bodies and investors. Joel has extensive experience with the following:
- Selection and writing of complete regulatory submissions , including 510(k), PMA, IDE and dossiers for international markets
- Budgeting of scientific and regulatory initiatives for meeting investment expectations
- Pre-clinical and clinical trial design, with clear endpoints for decision-making on investments for your overall scientific strategy
- Development and negotiation of adaptive and Bayesian scientific approaches with FDA in written, teleconference and face-to-face settings
- Due diligence on IP, stock and/or asset acquisition targets
- Detailed project plans for your brand strategy, including parallel pathways for regulatory, reimbursement and market adoption
- Detailed presentation development for building investor confidence in your regulatory, scientific and market adoption strategies
- Training and messaging to your sales channels so that your scientific “story” is understood and properly communicated to customers