TOXICOLOGICAL
RISK ASSESSMENT
FOR MEDICAL DEVICES

IMPLEMENTING BIOLOGICAL EVALUATION & CHEMICAL RISK ASSESSMENT

MASTERING THE INTEGRATION OF ISO 10993-1, ISO 10993-17, AND ISO 14971

ISO10993-1

ISO10993-17

ISO14971

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Bridge the Gap Between Chemistry and Clinical Safety

Join us for an intensive, two-day technical workshop designed to bridge the gap between analytical chemistry and clinical safety. This session provides a roadmap for navigating the evolving regulatory landscape of medical device biocompatibility.

EVENT DETAILS

Date

6 - 7 July 2026

Time

9:00 am – 5:00 pm

Location

Bangi Resort Hotel

Fee

RM 2,800.00

TRAINING HIGHLIGHTS

Risk Management Frameworks

Principles from ISO 14971 and ISO 10993-1.

TRA Methodology

Step-by-step assessment aligned with ISO 10993-17.

E&L Assessment

Identifying and interpreting extractables and leachables data.

Safety Thresholds

Practical derivation of TI, uncertainty factors, and MoS calculations.

Applied Learning

Hands-on case studies to prepare reports for regulatory submission.

TRAINING CONTENT

MODULE 1

Introduction to Medical Device Risk Management (ISO 14971)

MODULE 2

Biological Evaluation Strategy (ISO 10993-1)

MODULE 3

Introduction to Medical Device Risk Management (ISO 10993-17:2023)

MODULE 4

Practical Case Studies & Worked Examples

TARGET AUDIENCE

This workshop is highly recommended for professionals involved in medical device compliance:

Regulatory Affairs
Toxicologists
R&D Engineers
Quality Assurance

TOXICOLOGICAL RISK ASSESSMENT FOR MEDICAL DEVICES