RAPS Workshop: What the Updates to ISO 10993-1 Mean for Your Regulatory Strategy

The 2025 revision of ISO 10993-1 brings more than editorial changes. It deepens how biological risk is assessed, documented, and integrated into regulatory strategies. While the standard is moving forward internationally, the US cast a rare “No” vote during the FDIS ballot, raising pressing questions about future FDA alignment and fueling global debate.

This session will cut through the noise and dives into the practical and strategic implications of the updated standard, particularly for regulatory, quality, R&D and biocompatibility professionals who must now navigate increased scrutiny and potential regional divergence. Participants will learn how to align biological evaluation plans and reports with the new requirements, justify material equivalence more rigorously, and address elevated expectations for assessment of long-term safety and medical device lifecycle.

Through case studies and decision-making frameworks, the workshop will guide attendees in evaluating the impact on their product portfolios and internal documentation. Participants will walk away with a readiness checklist, risk mitigation tactics, and a clearer path to maintaining compliance in a shifting global landscape.

Whether preparing new submissions or remediating legacy files, this session enables professionals to move from reactive updates to proactive strategy and to communicate with confidence across regulatory jurisdictions.

Registration Fees & Deadlines

Learning Objectives

• Describe the key changes introduced in the 2025 revision of ISO 10993-1 and their implications for biological risk assessment
• Assess how these changes affect existing biological evaluation documentation as well as regulatory strategy
• Develop a practical action plan to align biological evaluation plans and reports with the revised standard while accounting for regional regulatory expectations.

Who Should Attend?

Who is the intended audience?

• Regulatory affairs professionals who build up regulatory strategy for medical devices and combination products
• Product quality experts who are involved into design and development and change management for medical devices and combination products
• R&D and biocompatibility professionals

Audience Learning Level

Intermediate: Content is designed based upon the assumption that individuals have basic knowledge of the topic(s) and/or demonstrated competence related to the topic(s). Higher-level concepts are introduced during lectures; exercises requiring synthesis and/or application of concepts are incorporated into the activity.

Advanced: Content is designed for individuals who are well-versed in most, if not all, concepts associated with the topic(s). Activities place a high concentration on analysis and application of concepts or demonstration of competencies through exercises such as case studies, scenario building, and group projects. A high level of participation is expected from each attendee.

Agenda

May 19 8:00 AM -12:00 PM ET [2 (15) minute breaks each day]

Speakers

Marina Daineko, MSc
Biocompatibility Consultant, Intrinsic Medical Group

Marina Daineko is a seasoned biocompatibility consultant based in Poland, specializing in ISO 10993-1. With extensive experience in the medical device industry, she adeptly develops biocompatibility assessment aligned with ISO 14971:2019, EU MDR as well as the FDA Guidance. Her expertise extends to ensuring compliance with regulatory requirements across various global markets. Marina's contributions to the field include speaking at conferences and delivering online training courses on biological safety and evaluation. Marina holds a master’s of science in analytical chemistry. In recognition of her contributions, she was nominated for the Women in Tech Award in 2023 and was named one of the top 25 MedTech Leading Voices on LinkedIn.

Beau Rollins, RM(NRM), CISS-EO
Head of Biocompatibility, ConvaTec

After obtaining his bachelor’s degree in microbiology from Weber State University, Beau Rollins has spent the past 20 years in working in biocompatibility at a contract laboratory (Nelson Laboratories), contract manufacturing (QTS) and medical device manufactures (Convatec & Arthrex). Beau is currently an ISO Delegate for ISO 10993, specifically on the Implantation, Irritation/Sensitization, Nanomaterial and Absorbable Materials working groups, US Co-chair for Implantation and nanomaterials, US AAMI member for ISO 11135 and ISO11737, member of the Society of Toxicology, was part of the in-vitro irritation development and validation for ISO and has received his RM(NRM) and CISS-EO. Beau currently is the head of biocompatibility at Convatec.

Cancellations and Refunds

RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation. All cancellation requests must be submitted in writing to support@raps.org. Cancellations will receive a full refund minus a 20% administrative fee. RAPS is unable to accept cancellations by phone.

Substitutions

Paid registration substitutions may be accepted with written approval from RAPS for requests received before the start of the event. To transfer a registration, email support@raps.org with the event title, name of the original registrant and the contact information for the new attendee.

Proof of Attendance

A certificate of attendance can be downloaded from the RAPS Learning Portal following the event.

Questions