In pursuit of continuous improvement and increased service offerings, we’ve expanded our ISO/IEC 17025:2017 scope with nine new validated test methods accredited by the Perry Johnson Laboratory Accreditation (PJLA). This latest expansion increases BDC Laboratory's total number of accredited test methods from 23 to 32, further strengthening our ability to provide trusted, high-quality testing for medical device manufacturers.
The newly accredited test methods include:
Flow Application with Pressure Measurement (i.e. flow rate) (ISO 10555-1)
Pressure Application with Flow Measurement (i.e. permeability) (ISO 25539-1, ISO 7198)
Compressive Force Testing (ISO 25539-1, ISO 25539-2, ISO 7198)
Pressure Application with Observation (i.e. leakage) (ISO 7198, ISO 11070, ISO 10555-4, ISO 10555-1, ISO 25539-2, ISO 20697, ISO 80369)
Qualitative Torque Strength and Torqueability (FDA Guidance for Coronary, Peripheral, and Neurovascular Guidewires)
Pressurized Burst Strength (ISO 10555-4, ISO 25539-1, ISO 25539-2, ISO 7198)
Multimode Durability (ASTM F2942, ISO 25539-1, ISO 25539-2)
Immersion Corrosion (ISO 10555-1, ISO 11070)
Impact Resistance (ISO 20697)
Accreditation to ISO/IEC 17025:2017 demonstrates that a laboratory operates under a robust quality management system and consistently produces precise, accurate, and reliable test data. The accreditation symbol on our test reports indicates that testing was performed in compliance with applicable standards using validated test methods.
As regulatory requirements continue to evolve, BDC remains committed to maintaining accreditation and continually expanding its accredited capabilities to better serve customers throughout the medical device development process.
See our full list of accredited tests.