San Francisco Bay Area Chapter In Person Event: 2026 Risks with Pharmaceutical & Medical Devices in the Supply Chain

Heinz Steneberg

President & CEO, MDSS USA

Heinz Steneberg is a seasoned professional with over 25 years of experience in the medical device and diagnostic industries. Throughout his extensive career, he has held roles in Regulatory Affairs, Quality Assurance, and Clinical Affairs. He has led many successful regulatory submission projects, including IDEs, PMAs, 510(k)s, and EU MDR & IVDR dossiers, as well as submissions to regulatory agencies in Asia and South America. He served as the management representative and as the Person Responsible for Regulatory Compliance (PRRC).

With a unique perspective gained from leadership roles, including VP of Regulatory Affairs at MTL, Executive Director of Regulatory and Quality Management at Quest Diagnostics, Head of Regulatory and Clinical at Carl Zeiss Meditec, and Director of Regulatory Affairs at Roche Molecular Diagnostics, as well as his foundational experience as a Division Manager at TUV Rheinland of North America's Medical Division, he is well positioned to offer clients the strategic advice needed to navigate product approvals and market access.

His passion is to work with innovative companies to accelerate the development of new medical and diagnostic solutions for patients.

: heinz-steneberg

Greg Adams

Head of Biopharma Science, SGS North America

Greg Adams is the Head of Biopharma Science at SGS North America (based in Apex, NC). He is a senior analytical development leader specializing in biologics, with over 28 years of experience driving successful IND-to-BLA submissions, protein analytics, and global strategies in the biopharmaceutical industry. His expertise includes characterization of protein-based biopharmaceuticals. He has prior experience at organizations such as FUJIFILM Diosynth Biotechnologies and others in the sector, focusing on enhancing service offerings, analytical method development, and achieving FDA approvals.

: greg-adams-3536a013

Jon Gawlak

Technical Manager/Senior Auditor, SGS North America

Over 35 years of Quality and Project Management Experience with over 29 years of Leadership Experience in the Pharmaceutical, Cosmetic, Personal Care, Food, and Medical Device Industry

Specialties: QA, QC, Supplier Qualification and Management, CMC, Quality Management, Project Management, Certification Auditing, Vendor Auditing, Internal Auditing, Analytical Testing, QC Laboratory Management

: jongawlak

Mingxiang Xu

Technical Director, SGS North America

Mingxiang (Ming) Xu began his professional journey over 31 years ago, building on a multidisciplinary foundation in science, engineering, and business. His career spans a diverse range of industries, including scientific research, electronic manufacturing, information technology, alternative energy, and medical devices.

Ming currently serves as Technical Director at SGS North America, where he supports clients in meeting the requirements of the EU MDR, MDD, and UK MDR. A prolific reviewer of both active (including software) and non-active medical devices, he works across Class lla to Class III product categories. He is also recognized as a subject matter expert in devices without an intended medical purpose (Annex XVI) and drug-device combination products (Article 117).

Earlier in his R&D career, Ming contributed to the development of medical devices such as infusion systems, electrosurgical units, and endoscopic imaging technologies. His broader technical expertise also includes ultrasonic imaging, electromagnetic navigation, irreversible electroporation, ultrasonic surgical instruments, surgical robotics, electrohydraulic lithotripsy systems, endoscopic balloon catheters, introducers, guidewires, tissue acquisition and apposition tools, and sealing solutions. He holds multiple U.S. patents, most of which relate to innovations in medical technology.

: mingxiangxu

Jessica Nicole Cansler

Board Member, EXCiPACT

Jessica holds a master’s in jurisprudence in Health Law from Seton Hall University and B.S. in Biomedical Engineering from Rutgers University. She has held various roles in Quality and Engineering within the Pharma and Biologics industries. She started her career at BASF in Sep 2011 as Quality Management Specialist for the North America region, gaining experiences in various quality realms and represented BASF’s Quality interests in various trade organizations (i.e., IPEC Americas, ASQ, etc.)

Jessica is now a Quality Compliance Manager for BASF Global Quality Governance. She is an America Society of Quality (ASQ) Certified Quality Auditor. As a member of IPEC America, she functions as the lead for the Education Strategy team and serve as an active contributing member for the GMP, Excipient Qualification, and QbD committees.

: jessicacansler

Hank Karayan

Global Head of Cosmetics and Pharma Assurance, Global FSMA Program Director

Hank Karayan is Global FSMA Program Director and Global Head of Cosmetics and Pharma Assurance at SGS. He began his career as a quality, GMP, food safety, and cosmetics consultant and trainer with a European multinational firm, where he built hands-on experience in strategic management, regulatory compliance, industry best practices, and Total Quality Management.

He has since led numerous projects for multinational organizations,SME s, and regulatory bodies across multiple geographies. John later transitioned into audit and compliance, specializing in supply-chain risk management, food safety strategy, food defense, information security, and management systems.

He holds a Bachelor of Science in Biology and an MBA, and is the author of multiple publications on food safety, food defense, FSMA, and strategic management.

: hankkarayan