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.
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]
|
Time ET |
Time CET |
Topic |
|
8am |
2pm |
Icebreaker “What is one thing about biocompatibility that gives you confidence… and one thing that still gives you headaches?” Overview of what ISO 10993-1:2025 really changes (vs. what stays the same) |
|
8-15am |
2-15pm |
Module 1: Key changes in ISO 10993-1:2025 |
|
9am |
3pm |
Discussion: With the changes introduced in ISO 10993-1:2025, what has been the biggest impact on how your organization approaches biological evaluation |
|
9-15am |
3-15pm |
BREAK |
|
9-30am |
3-30pm |
Module 2: FDA “No” Vote & Global Divergence |
|
10am |
4pm |
Mini exercise: Teams map a hypothetical device portfolio to EU vs US requirements and spot divergences |
|
10-15am |
4-15pm |
Module 3: Strengthened Requirements for Biological Risk Assessment |
|
10-45am |
4-45pm |
Practical Exercise: Participants evaluate an incomplete risk assessment and identify missing biological risks now required by ISO 10993-1:2025 |
|
11am |
5pm |
BREAK |
|
11-15am |
5-15pm |
Module 4: Practical Exercise: Gap assessment of an existing biological evaluation |
May 20 8:00 AM -12:00 PM ET [2 (15) minute breaks each day]
|
Time ET |
Time CET |
Topic |
|
8am |
2pm |
Warm-up task: “What gap surprised you the most from your Day 1?” |
|
8-15am |
2-15pm |
Module 5: Updating BEPs and BERs to 10993-1:2025 |
|
9am |
3pm |
Mini exercise: Participants are given 3 device descriptions and identify what additional considerations the 2025 revision now requires |
|
9-15am |
3-15pm |
BREAK |
|
9-30am |
3-30pm |
Module 6: Lifecycle Approach |
|
10-15am |
4-15pm |
Discussion: What constitutes sufficient biological safety evaluation at different phases of the medical device lifecycle |
|
10-30am |
4-30pm |
BREAK |
|
10-45am |
4-45pm |
Module 7: Impact on Regulatory Strategy |
|
11-00am |
5-00pm |
Module 8: Action Planning |
|
11-45am |
5-45pm |
Mini exercise: Your 90-day compliance action map |
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 [email protected]. 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 [email protected] 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
Contact the RAPS Support Center:
Call +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email [email protected].
Speakers
Marina Daineko MSc
Beau Rollins RM(NRM), CISS-EO
