GLOBAL REGULATORY

Streamline biocompatibility
evaluations

IQVIA MedTech provides expert guidance for biocompatibility evaluations. Our board-certified toxicologists and biological safety experts develop biological evaluation plans per ISO 10993-1, develop chemical characterization plans per ISO 10993-18, conduct risk assessments per ISO 10993-17, and support regulatory submissions for medical devices worldwide.

Sub Brands MedTech Homepage Regulatory Biocompatibility Services

Beyond checkbox testing: Strategic biological risk management for global approvals

Demonstrating biological safety is a foundational requirement for global market access. However, ISO 10993 compliance involves far more than checking-the-box testing. Global regulators recommend a risk-based approach that considers the device materials, type and duration of patient contact, chemicals that could release from the device, effects of manufacturing and downstream processing, macro- and micro-geometry, and other factors. This risk-based approach outputs a biological evaluation plan (BEP) comprised of tailored biological testing and/or chemical characterization testing to address any information gaps. Upon execution of the BEP, testing results are synthesized in a biological risk assessment (BRA) and formalized in a Biological Evaluation Report (BER). This risk-based approach applies throughout the total product lifecycle and is used to evaluate device changes and new post-market information or safety signals.

As part of our Global Regulatory offerings, IQVIA MedTech acts as your strategic consulting partner. We design tailored BEPs, manage testing execution by partnered test laboratories, and integrate biological safety evaluation directly into your Market Entry Roadmap, US FDA Regulatory Consulting & Submission Support, and Global Regulatory Support.

Navigating regional variations in global biocompatibility standards

While the ISO 10993 standard series (Biological Evaluation of Medical Devices) establishes baseline practices for medical device biocompatibility, each regulatory authority applies its own specific interpretations and guidance. Crucially, certain geographies do not recognize every aspect of the ISO 10993 framework, creating distinct submission risks depending on your target markets.

IQVIA MedTech brings expertise to bridge these regional gaps. Whether addressing specific US FDA expectations, European MDR/Notified Body requirements, or Japan’s PMDA standards, we ensure your biological safety strategy complies fully with the specific obligations of each target regulator.

Comprehensive biocompatibility services and toxicological support

We provide complete biological safety consulting for new devices, combination products, material/supplier changes, and post-market design modifications.

Develop ISO 10993-1 compliant Biological Evaluation Plans (BEP) and Biological Evaluation Reports (BER) tailored to device materials, tissue contact, and clinical exposure.

Design extractable and leachable (E&L) analytical chemistry strategies (ISO 10993-18:2020) and perform expert TRAs (ISO 10993-17) to identify chemicals that medical devices can release (e.g., impurities, manufacturing residues, degradants) and assess their toxicological risk.

Conduct specialized benefit-risk evaluations for Carcinogenic, Mutagenic, Reproductive toxicity (CMR), or Endocrine Disrupting (ED) substances to fulfill strict global requirements.

Author robust scientific rationales based on material composition and manufacturing processes in lieu of conducting unnecessary physical biocompatibility testing.

Design and evaluate viral safety and inactivation validation studies in compliance with ISO 22442 for animal-derived materials.

Design customized biological testing protocols, review test reports, and directly liaise with accredited test laboratories to initiate and manage testing.

Conduct gap assessments against the ISO 10993 series standards. Remediate legacy BEP and BER documentation to comply with the most recent revision of ISO 10993-1.

Author defensible responses to non-conformances and Additional Information requests from regulators (FDA, EU Notified Bodies, PMDA).

Strategic advantages of an expert-led biological evaluation

Partnering with IQVIA MedTech de-risks your regulatory path and optimizes testing expenditure.

MCRA IS NOW PART OF IQVIA MEDTECH

Your Strategic Partner in Regulatory Success

IQVIA MedTech and MCRA bring together regulatory expertise with advanced analytics, technology, and global reach. Whether you're preparing for FDA submission, EU MDR compliance, or global market entry, our integrated team provides the strategic guidance and operational support to move your product forward.

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A deep therapeutic & scientific bench across specialized clinical domains

The IQVIA MedTech team features former regulatory agency officials, biostatisticians, clinicians, medical writers, and biomedical engineers with specialization in an array of high-intent medtech therapeutic areas:

Cardiovascular
Neurology
General Surgery
Orthopedics, Spine & Musculoskeletal
Metabolic, Endocrine & Gastrointestinal
In Vitro Diagnostics
Digital Health
And more

Eliminate uncertainty in your biocompatibility testing pathway

Avoid over-testing, reduce development timelines, and ensure total compliance across your device lifecycle. Partner with our toxicologists and regulatory strategists today.

Frequently asked questions about biocompatibility testing services

IQVIA MedTech provides biological evaluation strategy, protocol development, toxicological risk assessments, regulatory support, and expert oversight throughout the testing process. While testing is conducted by accredited laboratories, clients can engage with IQVIA MedTech through multiple delivery models, including direct consulting engagements, collaboration with a client-selected laboratory, or integrated laboratory partnerships. This flexibility allows organizations to access specialized expertise through the engagement structure that best fits their needs.

While the ISO 10993 standard series (Biological Evaluation of Medical Devices) establishes baseline practices for medical device biocompatibility, individual regulatory bodies (such as the US FDA, European Notified Bodies, and Japan's PMDA) interpret these standards differently and may not accept all aspects of the standard series. IQVIA MedTech structures your strategy to satisfy regional nuances and agency-specific guidance.

Extractables and Leachables (E&L) testing is a form of chemical characterization per ISO 10993-18 that identifies and quantifies chemicals that release from your device. A toxicologist evaluates these chemical profiles in a toxicological risk assessment (TRA) per ISO 10993-17. If chemical levels do not pose a toxicological risk, manufacturers can frequently waive lengthy, expensive in vivo biological assays.

The integration brings the leadership of experienced biological safety experts directly into IQVIA MedTech. This enhances our capabilities in designing robust biological evaluation plans, evaluating novel materials, conducting complex toxicological risk assessments, and defending biocompatibility strategies before global regulatory bodies like the US FDA and European Notified Bodies.