Mechanical, physical, and accelerated aging laboratory testing for medical devices in accordance with recognized standards, documented for MDR-compliant technical documentation.
Each test is conducted using a product-specific test plan, calibrated equipment, and standards-compliant reporting, directly usable for technical documentation in accordance with MDR (EU) 2017/745.
Determination of yield strength, tensile strength, and elongation at break for materials and joints.
ISO 527 · ISO 6892 · ASTM D638
Testing of deformation and failure behavior under static compressive loading.
ISO 604 · ASTM D695
Determination of the fatigue limit under cyclic loading, relevant for implantable and long-term use products.
ISO 12107 · ASTM E466
Three- and four-point bending tests to determine flexural stiffness and the moment of failure.
ISO 178 · ASTM D790
Torsional moment and angular displacement testing for fasteners, catheters, and rod-shaped implants.
ISO 11135 · ASTM F543
Verification of the leak-tightness of packaging systems and fluid-carrying products under pressure and vacuum.
ASTM F2096 · ISO 11607
Testing of sterile packaging for seal strength, uniformity, and failure behavior.
ASTM F88 · ISO 11607-1
Determination of insoluble particles in solutions and on product surfaces. Cleanroom conditions in Pennsylvania.
USP <788> · ISO 14644
Validated method according to ASTM F1980 for simulating product lifespan under elevated temperatures.
ASTM F1980 · ISO 11607
In our laboratory in Hamm, we perform tensile, compression, flexural, and torsion tests as well as fatigue tests on products under cyclic loading. All laboratory testing equipment is calibrated according to DAkkS standards. The test reports are directly usable for technical documentation in accordance with MDR (EU) 2017/745: including standard references, product-specific test plans, and analyzable raw data.
We conduct aging tests in the climate test chamber, with temperature and humidity control in accordance with ASTM F1980 and ISO 11607. The storage and retrieval dates are documented, the aging factor is calculated, and the results are presented in a traceable manner in the test report.
For products that must be tested in a sterile environment, our ISO 14644-certified cleanroom in Pennsylvania is available. Particle contamination testing per USP <788>, sterility testing, and bioburden determinations are performed there under controlled conditions.
The facility is tailored to the requirements of the U.S. market: test reports are documented for FDA 510(k) and PMA procedures, and the measurement technology complies with 21 CFR Part 820 requirements. For manufacturers seeking both EU and FDA approval, we coordinate between Hamm and Pennsylvania to ensure that test plans and report documentation cover both markets.
Calculate the aging factor and expiration date for your accelerated aging study according to ASTM F1980. The calculation is based on the Arrhenius equation with an adjustable Q10 factor.
All values are guidelines and must be verified on a case-by-case basis. WQS assumes no liability.
The retrieval date marks the end of the accelerated ageing study, not the product release date. After retrieval, the specified product tests (mechanical tests, packaging integrity, functional tests) must be performed on the aged samples. The time required for laboratory testing and report preparation must also be factored into the overall planning. Based on experience, this takes 4–8 weeks.
Accelerated aging does not replace the real-time aging study. According to DIN EN ISO 11607-1:2024 (Sections 8.3.2 and 8.3.3), real-time aging is mandatory. Accelerated aging provides preliminary evidence until real-time data is available.
Tell us what tests your product requires, and we’ll clarify the standard reference, test plan, and documentation requirements.
MDR (EU) 2017/745 requires, in Annexes II and III, evidence of the product’s safety and performance. The specific testing standards to be applied depend on the product class, intended use, and type of contact. The basis is always a GSPR-compliant risk analysis, which determines the testing requirements.
In real-time aging, the product is stored under real-world conditions until the end of its intended shelf life. Accelerated aging shortens this period by using elevated temperatures. According to ASTM F1980, both studies are conducted in parallel; the real-time study does not replace accelerated aging but confirms its results over the long term.
For conformity assessment procedures under the MDR, it is recommended to use laboratories with DAkkS accreditation (Germany) or ISO/IEC 17025 certification. Notified bodies verify the calibration of the measurement equipment used and the traceability of the measurement results. Laboratory testing without proof of equipment calibration are considered insufficient.
Yes, provided the change affects safety or performance-related characteristics. MDR Article 83 and the corresponding MDCG Guidance define when a substantial change requires a new conformity assessment. Not every design change necessitates a full reassessment. However, a documented change assessment is mandatory in all cases.
This page provides regulatory information and does not constitute legal advice. Regulatory requirements vary by jurisdiction.
Support for US companies to enter the European market. EU Rep, Certification, QM System, Technical Documentation, support of the Procedure, selection of a Notified Body, support of the Certification Procedure, preparation of a Clinical Evaluation, support of Clinical Studies, including the Logistical Concepts.
Copyright 2024 WQS Management Consultants GmbH