10 ISO 13485 consultants

Experience: Principal Consultant · Kelly Quality & Compliance

Principal Consultant at Kelly Quality & Compliance since 2004, and New England Medical Device Board Member, Past Chair, Past Chair Elect at ASQ since 2006. Her profile describes her as a medical device and combination product compliance expert covering 21 CFR 820, ISO 13485, MDSAP and EU MDR, and a Certified Quality Auditor who conducts FDA third-party certification audits, readiness training, mock audits and gap assessments.

Experience: Medical Devices SME Consultant and Auditor Freelance · Erazo Consulting

Medical Devices SME Consultant and Auditor Freelance at Erazo Consulting since 2022. Former Director of Quality at Integer (2024), former Quality Assurance and Regulatory Affairs Head at Foxconn Baja California (2022–2023) and former Director Of Quality Assurance and Regulatory Affairs at Hillrom (2021–2022). Her profile says she helps organizations implement their QMS and obtain ISO 13485 certification, along with process validation, regulatory submissions and FDA preparedness.

Experience: Director & Management Consultant · QualiMedd Ltd.

Director & Management Consultant at QualiMedd Ltd. since 1990, and Quality Management System Consultant at Thermo Fisher Scientific since 2014. The profile also lists a Quality Assurance & Regulatory Affairs Director role at Advotek Medical Devices Ltd. since 2010, and says he has implemented FDA Part 820, ISO 9001 and ISO 13485 quality management systems worldwide and developed quality management system training programs.

Experience: Independent Consultant · Quality13485

Independent Consultant at Quality13485 since 2019. Former Chief Operations Officer at MXR Imaging (TN & FL Regional Divisions) (2019–2023), former Chief Compliance Officer at Oxford Instruments plc (2010–2019) and former ISO Manager Compliance at Oxford Instruments plc (2010–2018). Her profile says she is a Medical Devices Management System Lead Auditor for ISO 13485:2016 with FDA 21 CFR 820.

Experience: Managing Director · Martin Duffy Quality Consulting Ltd

Managing Director at Martin Duffy Quality Consulting Ltd since 2016, and former self-employed Quality Management Consultant (2015–2016). Former Director, Global Supply Chain Quality Assurance (2012–2015) and Head Of Quality Management (2007–2012) at Abbott. His profile describes a QA/RA consultant whose key areas of expertise include EU MDR / IVDR auditing, gap analysis, training and implementation, and ISO 13485:2016.

Experience: Senior Consultant and President · Carroll Quality Consult, Inc.

Senior Consultant and President at Carroll Quality Consult, Inc. since 2006, and Senior Associate at AccuReg, Inc. since 1992. Former Manager, Quality Systems and Regulatory Affairs and L.P. at FluoroMed, LP (1996–2006). Her profile lists quality system development and implementation for 21 CFR Parts 210 and 211, 21 CFR Part 820 and ISO 13485 among her specialties, with compliance work for pharmaceutical and medical device manufacturers.

Experience: Owner & CEO · qcmed Quality Consulting Medical GmbH

Owner & CEO at qcmed Quality Consulting Medical GmbH since 2006, and Managing Director at ac.biomed GmbH since 2010. Former Expert Trainer at TÜV Rheinland Akademie (2008–2016). His profile describes him as a medical device regulatory and quality expert, principal consultant, auditor and trainer, with the qcmed role covering medical device regulatory approval and quality systems including ISO 9001, ISO 13485 and MDSAP.

Experience: Founder & Principle Consultant · GMP Advisory Services

Founder & Principle Consultant at GMP Advisory Services since 2009, Senior Consultant at Boudicca® DX since 2025 and Senior Consultant at QualityHub since 2025. His profile describes a QA/RA leader specializing in EU and US regulations, with expertise in quality management systems, ISO 13485, design controls, clinical studies and software and process validation, and experience with medical device start-ups and large multinationals.

Experience: Owner Consultant · Total Quality Solutions LLC

Owner Consultant at Total Quality Solutions LLC since 2014, and Vice President Of Quality at 626 since 2021. Former Director of Quality & Regulatory Affairs at 626 (2020–2021). His profile describes him as a medical device quality and regulatory consultant with expertise in ISO 13485 and FDA 21 CFR 820, providing end-to-end quality and regulatory consulting for medical device manufacturers, suppliers and healthcare organizations.

Experience: Founder Principal Consultant · KeystoneQA Consulting Solutions LLC

Founder Principal Consultant at KeystoneQA Consulting Solutions LLC since 2025. Former Fractional Head of Quality CQO (Independent Consultant) at Pro-Dex, Inc. (2024–2025) and former Head of Quality and Regulatory Affairs at Resmed (2021–2024). Her profile lists quality systems acceleration for ISO 9001 and ISO 13485 and fractional QA and compliance leadership among her services.