10 medical device consultants
Regulatory and quality advice is the shared core of these medical device consultants, from Andre Butler's FDA submission work on 510(k), PMA, De Novo and IDE files to Jurjen Zoethout's EU and US guidance at Lucendra. Four of them also held RA, QA or R&D titles at director level or above at Medtronic, Heraeus Medical Components, Teleflex or AngioDynamics, useful for a device company choosing a pathway and the quality system it needs before launch.
Professionals to explore
Andre Butler (CCRP, CQA)
LinkedInExperience: Principal Consultant - Medical Device Quality & Regulatory · ADB Consulting & CRO Inc
Founder of ADB Consulting & CRO Inc and its Principal Consultant - Medical Device Quality & Regulatory since 2004, Andre Butler provides fractional director-level Quality Assurance and Regulatory Affairs leadership for device companies from Class I through Class III, SaMD/digital health and drug-device combination products. FDA submissions named include 510(k), PMA, De Novo and IDE. Andre Butler also held clinical trial and data roles at Medtronic (1999–2003) and Purdue Pharma L.P. (2003–2004).
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Erez Adiv
LinkedInExperience: Independent Senior Consultant · RA & QA Consultant – Medical Devices
Independent Senior Consultant (RA & QA Consultant – Medical Devices) since 2022, Erez Adiv was Senior Principal, MedTech Regulatory Solutions at IQVIA (2019–2021). Before that, Erez Adiv was CEO of MedicSense Ltd. (1999–2019), a regulatory affairs, quality assurance and clinical affairs consultancy Erez Adiv founded, and RA & QA Director at Medtronic (1998–1999). A fit for building a regulatory strategy tailored to one company.
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John Shepperson
LinkedInExperience: Managing Director · JO-JI Consultants Limited
New product registrations and submissions are part of the regulatory consultancy John Shepperson offers medical device manufacturers as Managing Director at JO-JI Consultants Limited, a title held since 2018. Earlier titles were Principal Technology Lead at Teva Pharmaceuticals (2017–2018), Senior Regulatory Consultant at JRI Orthopaedics (2017), Senior Associate at MAETRICS (2016–2017) and Senior Compliance and Approvals Engineer at Dyson (2015–2016).
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José E. Cabrera
LinkedInExperience: Principal Consultant - Owner Operator · De Novo MedTech FDA Consulting
José E. Cabrera has been Principal Consultant - Owner Operator at De Novo MedTech FDA Consulting since 2020, right after Vice President of Regulatory Affairs and Quality Assurance at Heraeus Medical Components (2019–2020). Earlier titles include the same VP title at Somahlution (2014–2018), Senior Consultant at Halloran Consulting Group (2013) and Associate Director Regulatory Affairs at Medtronic (2011–2013). FDA De Novo re-classifications are a named specialty.
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Jurjen Zoethout
LinkedInExperience: Senior Partner Regulatory, Quality, Clinical & Scientific Affairs MedTech · Lucendra | MedTech Consulting
Jurjen Zoethout has been Senior Partner Regulatory, Quality, Clinical & Scientific Affairs MedTech at Lucendra | MedTech Consulting since 2025, guiding MedTech firms through EU and US regulatory, quality and clinical requirements. At Medidee - Now a Part of Veranex, Jurjen Zoethout was VP Regulatory and Quality MedTech Consultancy (2023–2025) and Director & COO Regulatory, Quality & Clinical Affairs MedTech (2021–2023), and coaches for Innosuisse and EISMEA.
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Liz Munro
LinkedInExperience: Medical Device Consultant and Fractional Executive · Liz Munro Consulting Inc.
Early product strategy suits Liz Munro, who in their own words acts as a fractional executive and product development and regulatory advisor to MedTech companies. Two current titles, both since 2025, are Medical Device Consultant and Fractional Executive at Liz Munro Consulting Inc. and Principal Consultant at Avania, after Vice President, Strategic Consulting at Avania (2024–2025) and Chief Operating Officer at Ironstone Product Development | Now Avania (2022–2024).
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Raj Duggineni
LinkedInExperience: Consultant · R&D-Regulatory-Quality Consultant
Orthopedic, hemostatic, active, software as a medical device, ablation and optical devices are the device types Raj Duggineni cites, working as an R&D-Regulatory-Quality Consultant since 2019, after Consultant-Stryker Orthopedics at RQM+ (2018–2019). Earlier titles include Director of R&D at Teleflex Trauma & Emergency Medicine (2015–2017) and Director of Knee Engineering at Iconacy Orthopedic Implants (2011–2013).
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Richard Basler
LinkedInExperience: Former Chairman & Managing Director · Med-Visory Consulting, Inc.
Since 1999 Richard Basler has been Chairman & Managing Director at Med-Visory Consulting, Inc., and was a Consultant at Edwards Lifesciences (2011–2014). Richard Basler cites experience with FDA, ISO and Canadian requirements, quality systems, CE marking and international licensing, and with submissions such as IDEs. Earlier titles include Director of Quality at Laurus Medical (1996–1997) and at Applied Medical Resources (1989–1995).
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William Hassel
LinkedInExperience: 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, William Hassel also lists Quality Assurance Consultant at Xoran Technologies (2015) and CAPA Engineer at Terumo Cardiovascular (2013). William Hassel describes consulting on design, compliance, quality, risk management and regulatory work for clients from start-ups to major multinationals, so suits risk management questions.
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Yossi Muncher
LinkedInExperience: CEO and Senior Consultant · ReguclinBiomedical Consulting Ltd.
Yossi Muncher has been CEO and Senior Consultant at ReguclinBiomedical Consulting Ltd. since 2020, after Director, Regulatory and Clinical Affairs at AngioDynamics (2019–2020) and Executive VP, Clinical Developement and Regulatory Affairs at Eximo Medical Ltd. (2016–2019). Yossi Muncher is a certified ISO 13485 auditor and GCP auditor and describes consulting on strategic development, fundraising, R&D and pre-clinical development.
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Choose the right perspective
For an FDA De Novo question, José E. Cabrera names it as a specialty; for an EU-led plan, Jurjen Zoethout or Richard Basler, who cites CE marking. If the real gap is product development rather than paperwork, Raj Duggineni and Liz Munro bring R&D and development backgrounds, and Yossi Muncher covers clinical work and fundraising.
Questions to take into the conversation
- 01Would you take our device down a 510(k), De Novo or PMA route, and what predicate or clinical evidence would decide it?
- 02What is the smallest ISO 13485 quality system we can run before our first submission without having to rebuild it later?
- 03How should we sequence design controls, testing and clinical work so one data package serves both FDA and the EU?
About this directory
This is a professional research starting point based on business profile data retrieved on . Titles and companies reflect that source snapshot; roles marked former had ended by then. Check the linked profiles for current details. Inclusion does not imply Instant Expert membership or availability.