10 medical device consultants

Experience: Principal Consultant - Medical Device Quality & Regulatory · ADB Consulting & CRO Inc

Principal Consultant - Medical Device Quality & Regulatory at ADB Consulting & CRO Inc since 2004. The profile describes founding the firm and providing fractional director-level quality assurance and regulatory affairs leadership for medical device companies, from Class I through Class III, SaMD/digital health and drug-device combination products, with services including FDA submissions such as 510(k), PMA, De Novo and IDE.

Experience: Independent Senior Consultant · RA & QA Consultant – Medical Devices

Independent Senior Consultant (RA & QA Consultant – Medical Devices) since 2022. Former Senior Principal, MedTech Regulatory Solutions at IQVIA (2019–2021), CEO of MedicSense Ltd. (1999–2019), which the profile describes as a regulatory, quality and clinical affairs consultancy assisting medical device companies, and RA & QA Director at Medtronic (1998–1999).

Experience: Managing Director · JO-JI Consultants Limited

Managing Director at JO-JI Consultants Limited since 2018. The profile describes a senior regulatory affairs and quality assurance consultant providing consultancy services to medical device manufacturers, including new product registrations and submissions. Former Senior Regulatory Consultant at JRI Orthopaedics (2017) and Senior Associate at MAETRICS (2016–2017).

Experience: Principal Consultant - Owner Operator · De Novo MedTech FDA Consulting

Principal Consultant - Owner Operator at De Novo MedTech FDA Consulting since 2020. Former Vice President of Regulatory Affairs and Quality Assurance at Heraeus Medical Components (2019–2020), Senior Consultant at Halloran Consulting Group, Inc., a PLG Company (2013) and Associate Director Regulatory Affairs at Medtronic (2011–2013). The profile lists clinical, quality assurance and regulatory affairs expertise with a specialty in FDA De Novo re-classifications.

Experience: Senior Partner Regulatory, Quality, Clinical & Scientific Affairs MedTech · Lucendra | MedTech Consulting

Senior Partner Regulatory, Quality, Clinical & Scientific Affairs MedTech at Lucendra | MedTech Consulting since 2025. Former VP Regulatory and Quality MedTech Consultancy (2023–2025) and Director & COO Regulatory, Quality & Clinical Affairs MedTech (2021–2023) at Medidee - Now a Part of Veranex. The profile says the Lucendra role focuses on guiding MedTech firms through regulatory, quality and clinical requirements in the EU and US.

Experience: Medical Device Consultant and Fractional Executive · Liz Munro Consulting Inc.

Medical Device Consultant and Fractional Executive at Liz Munro Consulting Inc. since 2025, and Principal Consultant at Avania since 2025. Former Vice President, Strategic Consulting at Avania (2024–2025) and Chief Operating Officer at Ironstone Product Development | Now Avania (2022–2024). The profile says she acts as a fractional executive and as a product development and regulatory advisor in MedTech.

Experience: Consultant · R&D-Regulatory-Quality Consultant

Consultant (R&D-Regulatory-Quality Consultant) since 2019, and former Consultant-Stryker Orthopedics at RQM+ (2018–2019). The profile describes a medical device consultant with R&D, regulatory and quality experience across orthopedic, hemostatic, active, software as a medical device, ablation and optical devices. Former Director of R&D at Teleflex Trauma & Emergency Medicine (2015–2017).

Experience: Chairman & Managing Director · Med-Visory Consulting, Inc.

Chairman & Managing Director at Med-Visory Consulting, Inc. since 1999, and former Consultant at Edwards Lifesciences (2011–2014). The profile describes regulatory and quality assurance work covering FDA, ISO and Canadian requirements, quality systems and CE marking, and assisting medical device manufacturers with regulatory strategies and submissions such as IDEs. Former Director of Quality at Applied Medical Resources (1989–1995).

Experience: Owner & Lead Consultant · Project MedTech, Inc.

Owner & Lead Consultant at Project MedTech, Inc. since 1998, and Risk Management Consultant at Johnson & Johnson MedTech since 2013. The profile describes a medical device consultant covering design, compliance, quality, risk management and regulatory work, with a client base from start-ups to major multinationals. Other rows include Quality Assurance Consultant at Xoran Technologies (2015).

Experience: CEO and Senior Consultant · ReguclinBiomedical Consulting Ltd.

CEO and Senior Consultant at ReguclinBiomedical Consulting Ltd. since 2020. The profile describes a medical device business consultant covering strategic development, fundraising, R&D and pre-clinical development, and a certified ISO 13485 and GCP auditor. Former Director, Regulatory and Clinical Affairs at AngioDynamics (2019–2020) and Executive VP, Clinical Developement and Regulatory Affairs at Eximo Medical Ltd. (2016–2019).