MEDICAL DEVICE TESTING

ORIOS LifeSciences provides specialized testing services dedicated to medical devices, supporting customers from early product characterization through Verification & Validation and process qualification.

Our objective is to combine measurement accuracy, technical expertise and regulatory understanding to generate reliable and meaningful data throughout product development and industrialization.

During the development phase, ORIOS can help customers characterize their devices and establish appropriate technical specifications.

This may include:

• Material characterization
• Mechanical property evaluation
• Identification of critical dimensions and tolerances
• Dimensional and geometrical characterization
• Surface condition assessment
• Definition of technical specifications supporting manufacturing and quality control

Our laboratory performs both standardized and customized tests depending on the product and customer requirements.

Testing activities include feasibility studies, product Verification & Validation, manufacturing process qualification and validation support.

Our capabilities include:

High-Precision Dimensional Measurement

• Diameter measurements
• Length measurements
• Angles and geometrical features
• Cross-section measurements
• Optical microscopy
• Profile measurement
• Surface and coating inspection

Mechanical Testing

• Tensile testing
• Compression testing
• Flexural testing
• Bond strength testing
• Burst pressure testing
• Fatigue testing
• Balloon compliance testing

These capabilities are particularly relevant to catheter-based and balloon medical devices.

Leak & Integrity Testing

• Air leak testing
• Device integrity testing
• Particulate testing
• USP <788> particulate evaluation where applicable

Material & Device Resistance Testing

Depending on project requirements, ORIOS can support:

• Corrosion testing
• Accelerated aging
• Storage-condition studies
• Transport-condition studies

Functional & Simulated-Use Testing

For catheter and interventional devices, ORIOS can perform functional evaluations using anatomical models and dedicated test benches.

Testing may include:

• Navigability
• Simulated use
• Friction / gliding performance
• Hydrophilic coating performance
• Coating durability
• Catheter handling and functional evaluation

ORIOS can develop dedicated test protocols when standard methods do not fully address a device's specific characteristics.

Our team can support the complete testing workflow:

• Definition of test strategy
• Protocol preparation
• Sample preparation
• Test execution
• Statistical analysis
• Technical interpretation
• Reporting

Our reports are designed to provide both raw data and technically relevant conclusions that can directly support product development, regulatory documentation and engineering decisions.

We are looking to connect with companies requiring a flexible, responsive testing partner capable of performing both standardized and customized testing for medical devices.