Testing in the medical device sector is expanding beyond traditional biocompatibility and performance evaluations. Recent regulatory updates—most notably the FDA’s finalized cybersecurity guidance—have tied software risk management, labeling, and documentation directly to quality system requirements.
This shift means device validation now extends beyond physical safety into digital security. Combined with ISO standards for quality management and risk, laboratories supporting device testing must ensure structured, auditable, and inspection-ready evidence across both physical and digital dimensions.
Core Trends Reshaping Test Menus
1. Cybersecurity Testing as Part of Validation
Connected and software-driven devices must now undergo cybersecurity risk assessments during development and validation. Labs are expected to support manufacturers with evidence of vulnerability testing, patch management, and secure labeling practices.
A lot is changing in consumer products, pharmaceuticals and biopharmaceuticals, environmental testing, metals and mining, food and beverage, medical devices, and cross-industry innovations.
If you are a third-party or contract testing lab, you need to know why the sector is shifting, the core trends reshaping test menus and methods, and the recent developments affecting operations, so you can take practical steps now to stay competitive.
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2. Biocompatibility with Structured Submissions
While ISO 10993 biocompatibility testing remains essential, regulators are increasingly requiring structured data submissions that allow inspection-ready audit trails. Labs must integrate digital documentation tools to deliver results that regulators and auditors can parse efficiently.
3. Integration with Quality Management Systems (QMS)
ISO 13485 and ISO 14971 have reinforced the expectation that device testing integrates directly into risk management and QMS processes. This includes documenting uncertainties, chain of custody records, and digital traceability for both hardware and software components.
Recent Developments Affecting Lab Operations
The regulatory environment surrounding medical devices has evolved rapidly, pushing testing laboratories to broaden their service portfolios and strengthen compliance infrastructure. Several developments are directly reshaping expectations for third-party labs:
- Expanded FDA scrutiny of labeling accuracy, cybersecurity documentation, and software validation
The FDA’s final cybersecurity guidance now applies across the device life cycle, requiring manufacturers—and their contract labs—to demonstrate secure development practices, vulnerability management, and documentation traceability. Regulators increasingly review labeling for accuracy, completeness, and consistency with validated cybersecurity controls. This trend means labs must be prepared to supply evidence that digital risks have been addressed with the same rigor as biocompatibility or performance testing.
- Growth in in vitro and computational alternatives to animal testing
As refinement and reduction principles gain traction, regulators are encouraging scientifically sound in vitro assays, computational models, and organ-on-chip systems when applicable. For ISO 10993 biological safety evaluations, laboratories are seeing increased demand for validated in vitro cytotoxicity, irritation, and sensitization testing, supported by method verification data and clear applicability criteria. Labs that can offer these alternatives position themselves as future-ready partners while helping clients reduce reliance on animal models where feasible.
- Emphasis on digital threads linking laboratory data to manufacturers’ QMS platforms
Manufacturers must increasingly demonstrate “digital continuity”—a traceable path from raw data to regulatory submission. For labs, this translates to generating structured, machine-readable data sets and maintaining interoperable documentation. FDA’s ongoing push toward electronic submissions, combined with the quality management expectations in ISO 13485 and ISO 14971, means labs must treat their data systems as integral components of the device manufacturer’s audit trail. Structured audit logs, timestamped metadata, and controlled document histories are becoming expected rather than optional.
- Rising expectations for post-market surveillance (PMS) support
With more devices incorporating networked or software-driven components, PMS now extends to cybersecurity event monitoring, data integrity checks, and verification of software updates. Contract labs are increasingly being asked to support PMS workflows through periodic re-testing, verification of patch efficacy, and documentation aligned with MDR, IVDR, and FDA PMS expectations.
Practical Steps for Laboratories
To stay competitive and compliant in this expanded regulatory landscape, laboratories should strengthen both operational capabilities and documentation practices. The following actions help align services with FDA expectations, ISO standards, and the evolving needs of device manufacturers:
1. Expand validation scope to include cybersecurity testing
Labs should integrate cybersecurity risk evaluation into their test menus—such as penetration testing, vulnerability scanning, software bill of materials (SBOM) verification, and secure configuration assessments. This work must be documented in a manner consistent with FDA cybersecurity guidance and aligned with ISO/IEC 81001-5-1 for health software security.
2. Formalize digital documentation practices for structured submissions
Contract labs should produce structured electronic submissions, including machine-readable Certificates of Analysis (CoAs), searchable test reports, and electronic raw-data files that feed seamlessly into clients’ QMS and regulatory submission systems. Using controlled templates, standardized terminology, and metadata tagging improves audit readiness and reduces back-and-forth during FDA or notified-body reviews.
3. Strengthen integration with client QMS and risk management processes
Because the ISO 13485 and ISO 14971 require full traceability, labs must link their results to manufacturers’ risk files. This includes documenting test uncertainties, clearly identifying nonconformances, and providing transparent chain-of-custody logs. Strengthening traceability for both physical samples and software artifacts ensures seamless incorporation of lab results into design history files (DHF), technical documentation, and corrective and preventive action (CAPA) programs.
4. Prepare for deeper regulatory inspections and data traceability reviews
Regulators increasingly expect labs to demonstrate method validation, data integrity controls, and auditable digital pathways from acquisition to reporting. Labs should maintain up-to-date SOPs, instrument qualification records, cybersecurity controls for laboratory information systems, and fully traceable documentation packages. Periodic internal audits and mock inspections can help ensure readiness for FDA or ISO 17025 assessments.
5. Invest in capabilities aligned with next-gen device technologies
As devices become more software-enabled and connectivity-driven, labs should build expertise in areas such as wireless coexistence testing, software lifecycle verification, electrical safety updates, and functional testing under simulated real-world environments. Expanding in vitro alternatives and computational modeling capabilities can also attract clients seeking modern, regulator-aligned testing strategies.
Set Your Lab up for Success
Medical device testing is broadening to include cybersecurity, digital traceability, and structured evidence submissions. Laboratories that align testing with ISO and FDA frameworks, and that strengthen digital documentation, will remain indispensable partners in an increasingly complex regulatory landscape.
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This article was created with the assistance of Generative AI and has undergone editorial review before publishing.