Technical expertise to support your testing

At ORIOS LIFESCIENCES, our laboratory—equipped with the latest testing technologies—serves companies in the medical device industry. We support you from the design phase through to the final validation of your products, ensuring accuracy, compliance, and performance.

Custom Solutions for Your Needs

Characterization & Definition of Specifications

During the development phase of your product, we help you define its technical requirements:

  • Materials analysis: Determination of mechanical properties (modulus of elasticity, strength, ductility).
  • Determination of critical tolerances: diameters, lengths, specific cross-sections, surface finishes.
  • Preparation of technical data sheets: Clear specifications for manufacturing, quality control, and regulatory compliance (ISO 13485, MDR, FDA).

Complex Tests & Validated Methods

We conduct customized tests tailored to your specific needs, using validated protocols to ensure the reproducibility and reliability of the results:

  • Feasibility testing: Early validation of concepts (prototypes, materials, assemblies).
  • V&V (Verification & Validation) Testing: Experimental evidence for regulatory submissions (CE, FDA, MDSAP).
  • Process Qualification and Validation (PQ, IQ, OQ): Verification that your production lines meet the defined requirements.

Our Services

High-Precision Dimensional Measurements

  • Three-dimensional inspection (CMM, profile projectors, optical microscopes).
  • Measurement of diameters, lengths, angles, and cross-sections (micrometer-level tolerances).
  • Analysis of surface conditions (roughness, defects, coatings).

Mechanical Testing – Strength & Durability

  • Tensile/compression/bending tests (ISO 10555-1, ASTM D638): Determination of tensile strength, Young’s modulus, and elongation.
  • Burst and fatigue tests (ISO 10555-4): Resistance to hydraulic pressure.
  • Compliance testing: Evaluation of deformation under stress (ISO 10555-4).

Leak and Integrity Tests

  • Air leak tests: Checking the tightness of devices.
  • Comptage particulaire (ISO 14644, USP <788>)

Stress Testing of Materials and Devices

  • Corrosion testing (ISO 9227, ASTM B117): Evaluation of resistance to body fluids, saline solutions, and disinfectants.
  • Accelerated aging tests (ASTM F1980)
  • Testing of storage and transport conditions.

Sterile Barrier Tests - ISO 11607

  • Visual inspection (ASTM F1886).
  • Peel strength test (ASTM F88, EN 868-5 Annex D).
  • Peel test (EN 868-5 Annex E).
  • Leak tests (Dye Leak Test - ASTM F1929 and Bubble Test - ASTM F2096).
  • Burst resistance (ASTM F2054).

Functional Tests

  • Navigation and usability testing (simulated use) - ASTM F2394: Evaluation of maneuverability in anatomical models (vascular simulators, synthetic tissues).
  • Slip tests and evaluation of hydrophilic coatings: Measurement of coefficient of friction, wear resistance, and coating effectiveness (catheters, guidewires).

Why Choose ORIOS LIFESCIENCES?

Industry Expertise

  • A team of specialists in mechanical testing for medical devices, with in-depth knowledge of standards (ISO, ASTM, RDM, FDA).
  • Validated and traceable methods: Each test is documented in accordance with the requirements of the notified bodies.

State-of-the-Art Equipment

  • High-precision machines
  • A wide range of machines for a wide variety of tests
  • Dedicated rooms for testing under controlled conditions (temperature, humidity).

Flexible & Responsive Approach

  • Standardized tests or customized protocols tailored to your needs.
  • Streamlined processes to accelerate your time-to-market.
  • Clear, actionable reports: Raw data, statistical analyses, and recommendations for improvement.

Compliance & Security

  • Compliance with regulatory requirements: Our testing supports your technical dossiers (CE, FDA, MDSAP).
  • Guaranteed confidentiality: Protection of your intellectual property and data.

Ready to Test Your Devices' Performance?

Whether you need a one-time test or comprehensive support for your project, our team is here to help.

Contact Us