GLP-Compliant & ISO 17025 Medical Device Testing Lab

Medical device testing laboratories that support regulatory submissions typically operate within two established quality frameworks: Good Laboratory Practice (GLP) and ISO/IEC 17025 accreditation. GLP defines requirements for the planning, conduct, monitoring, documentation and reporting of non-clinical safety studies, while ISO/IEC 17025 establishes the international standard for the technical competence of testing laboratories, including method validation, calibration, measurement traceability and quality management.

Hohenstein conducts medical device testing within GLP-compliant laboratory systems according to 21 CFR Part 58 and OECD principles and maintains ISO/IEC 17025 accreditation from DAkkS for biological, chemical and physical testing.

ISO/IEC 17025 Accredited Medical Device Testing Laboratory

ISO/IEC 17025 is the international standard defining the general requirements for the competence of testing and calibration laboratories.

Hohenstein maintains ISO/IEC 17025 accreditation through the German Accreditation Body (DAkkS) for biological, chemical and physical testing relevant to medical devices.

For medical device manufacturers, ISO/IEC 17025 accreditation demonstrates that laboratory testing is performed within a quality system emphasizing validated methods, calibrated equipment, measurement traceability and documented procedures.

ISO/IEC 17025 accreditation demonstrates that:

Testing methods are validated and appropriately controlled
Laboratory instruments are calibrated and maintained
Personnel are qualified and trained for assigned responsibilities
Measurement results are traceable and reproducible
Laboratory processes follow a documented quality management system

These practices support reliable data generation for analytical testing, material characterization and physical evaluation of medical devices.

GLP-Compliant Laboratory for Medical Device Safety Studies

Good Laboratory Practice (GLP) establishes regulatory requirements for how non-clinical laboratory studies supporting regulatory submissions must be conducted.

In the U.S., GLP requirements are defined in 21 CFR Part 58. Internationally, they are harmonized through the OECD Principles of Good Laboratory Practice, which support mutual acceptance of safety data among participating countries.

Hohenstein is one of the few medical device testing labs certified for chemical, physical and biological testing.

GLP-compliant laboratory systems ensure that studies are conducted within a controlled framework that supports data integrity, traceability and regulatory oversight.

Key elements of GLP-compliant study conduct include:

Defined study protocols and test systems
Independent quality assurance monitoring
Controlled data collection and documentation
Standardized study reporting procedures
Long-term archiving of study records and materials

Within medical device development, GLP-compliant testing commonly supports non-clinical safety evaluation conducted according to ISO 10993 biological evaluation standards.

Hohenstein GLP Certificate
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All Hohenstein Laboratories Accreditations

Supporting Medical Device Regulatory Submissions

Laboratory testing conducted within GLP-compliant and ISO/IEC 17025 accredited systems supports data generation for a range of medical device regulatory pathways, including:

FDA premarket submissions, including 510(k) and PMA
EU MDR Technical Documentation reviewed by Notified Bodies
International submissions supported through OECD GLP mutual acceptance of data

These frameworks help ensure that laboratory data is traceable, reproducible and documented according to internationally recognized quality systems, supporting regulatory review as part of a device submission.

GLP
GLP vs ISO/IEC 17025
FDA Submissions
ISO 10993
E&L Studies

GLP

What is a GLP-compliant medical device testing laboratory?

A GLP-compliant laboratory conducts non-clinical safety studies according to Good Laboratory Practice (GLP) requirements.

In the United States, these requirements are defined by FDA GLP regulations (21 CFR Part 58), while internationally they are harmonized through the OECD Principles of Good Laboratory Practice.

These frameworks establish how non-clinical studies must be planned, conducted, monitored, documented and reported to ensure the integrity, traceability and reliability of study data used in regulatory submissions.

GLP vs ISO/IEC 17025

GLP vs ISO/IEC 17025: What Is the Difference?

Although both frameworks are widely used in laboratory testing, Good Laboratory Practice (GLP) and ISO/IEC 17025 accreditation address different aspects of quality and regulatory readiness.

GLP governs how non-clinical safety studies are planned, conducted, monitored and reported, ensuring that study data used in regulatory submissions is documented and traceable. ISO/IEC 17025 focuses on the technical competence of testing laboratories, including validated methods, calibrated equipment and measurement traceability.

In medical device testing, these frameworks often work together to support reliable laboratory data.

Quality Framework	Primary Focus	Typical Application
GLP	Study conduct and documentation	Non-clinical studies supporting regulatory submissions
ISO/IEC 17025	Laboratory technical competence	Analytical, chemical and physical testing

For medical device manufacturers, laboratories operating within both frameworks provide assurance that testing is conducted within recognized regulatory and technical quality systems.

FDA Submissions

Is GLP required for FDA medical device submissions?

For non-clinical safety studies included in FDA submissions such as 510(k) or PMA, sponsors must state whether the studies were conducted in compliance with 21 CFR Part 58 (GLP regulations).

In practice, most non-clinical safety studies are expected to follow GLP requirements.

ISO 10993

Which ISO 10993 studies are typically conducted under GLP?

Many ISO 10993 biological safety studies are performed within GLP-compliant laboratories when the results are intended for regulatory submissions. These studies generate non-clinical safety data, and regulatory authorities such as the FDA expect this type of data to be produced under controlled and well-documented study conditions.

Good Laboratory Practice (GLP) provides the framework for how these studies are planned, conducted, monitored, documented and reported, ensuring that the resulting data is traceable, auditable and suitable for regulatory review.

Examples of ISO 10993 studies commonly conducted under GLP include:

Cytotoxicity (ISO 10993-5)
Sensitization (ISO 10993-10)
Irritation or intracutaneous reactivity (ISO 10993-23 / 10993-10)
Systemic toxicity (ISO 10993-11)
Genotoxicity (ISO 10993-3)
Implantation studies (ISO 10993-6)

Analytical testing used in biological evaluation, such as chemical characterization or extractables and leachables studies, may instead be conducted within ISO/IEC 17025 accredited laboratory systems, depending on the regulatory strategy.

Medical Device Biocompatibility

E&L Studies

Does extractables and leachables testing require GLP?

The appropriate quality framework is typically determined based on how the data will support the overall ISO 10993 biological evaluation and regulatory strategy.

Extractables and leachables studies may be conducted under GLP-compliant or ISO/IEC 17025 accredited laboratory systems, depending on the regulatory strategy and how the data will be used within a biological safety evaluation.

In many cases, these studies are performed under ISO/IEC 17025 accreditation because they focus on analytical measurement and chemical characterization, rather than non-clinical safety study conduct. ISO/IEC 17025 demonstrates the technical competence of the laboratory, including validated analytical methods, calibrated instruments and traceable measurements.

GLP may be used when extractables or leachables data is generated as part of a non-clinical safety study supporting regulatory submissions or when the results are used directly in toxicological risk assessments.

Medical Device Extractables and Leachables Testing

GLP-Compliant & ISO/IEC 17025 Accredited Medical Device Testing Laboratory