Testing and Validation Services

At B+solutions, we understand that rigorous testing and validation are essential to ensure the safety and effectiveness of medical devices. Our comprehensive Testing and Validation Services cover a wide range of evaluations to help you meet regulatory requirements and bring high-quality products to market. Our expertise spans several key areas:
Biological Evaluation
We offer a full suite of biological testing services in accordance with the ISO 10993 series, ensuring your device’s biocompatibility:
• Biocompatibility Testing (ISO 10993): Assessing the compatibility of materials with biological systems.
• Cytotoxicity Testing (ISO 10993-5): Evaluating the potential of materials to cause cell damage.
• Irritation Testing (ISO 10993-10): Testing for skin or tissue irritation responses.
• Sensitization Testing (ISO 10993-10): Determining whether a material could trigger an allergic response.
• Systemic Toxicity Testing (ISO 10993-11): Evaluating potential toxic effects on the entire body.
• Pyrogenicity Testing (ISO 10993-11): Assessing the presence of substances that could cause fever.
• Biodegradation Testing (ISO 10993-14): Determining the rate and extent of material breakdown.
• Toxicological Risk Assessment (TRA): Evaluating the safety of materials based on toxicological data.
Chemical Characterization
Our chemical testing services ensure the safety and stability of materials used in your products:
• Chemical Identification and Quantification: Identifying and measuring chemical components.
• Material Characterization (BEP, BER): Evaluating material properties and composition.
• Extractable/Leachable (E/L) Testing: Detecting substances that could migrate from materials.
• Heavy Metal Testing (RoHS, REACH): Ensuring compliance with regulations on hazardous substances.
• Chemical Stability Testing: Assessing material stability over time under various conditions.
Physical and Mechanical Testing
We provide a range of tests to evaluate the physical integrity and performance of your device:
• Electrical Safety Testing (IEC 60601): Verifying that devices meet electrical safety standards.
• Electromagnetic Compatibility (EMC) Testing: Ensuring devices do not interfere with or are not affected by electromagnetic fields.
• Performance Testing and Verification: Confirming that the device performs as intended.
• Material Testing and Characterization: Assessing the mechanical properties of materials.
• Sterilization Validation and Testing: Verifying the effectiveness of sterilization processes.
• Packaging Testing and Validation: Ensuring packaging protects the device during shipping and storage.
• Environmental Testing (Temperature, Humidity, Vibration): Evaluating device performance under various environmental conditions.
• Climatic and Durability Testing: Testing the resilience of devices to different climate factors.
Microbiological Testing
We help ensure the sterility and antimicrobial effectiveness of your devices:
• Sterility Testing (ISO 11137): Verifying the absence of viable microorganisms.
• Bacterial Endotoxin Testing (USP): Testing for bacterial toxins that could cause fever.
• Fungal and Bacterial Contamination Testing: Detecting potential microbial contamination.
• Antimicrobial Efficacy Testing: Evaluating the effectiveness of antimicrobial treatments.

With our Testing and Validation Services, B+solutions ensures that your medical devices meet the highest standards for safety and performance, giving you confidence in their regulatory compliance and market readiness.