• Advisory
• Training

Perform document and construction review at early phase of your product design.

RM files, Critical Components, IEC 60601, IEC 61010, IEC 62304

Perform calibration on equipment used in manufacturing and laboratories to ensure precision and accuracy of equipment.

Dimensional, Force, Flow, Pressure, Electrical Parameter, Temperature, Humidity.

Test device’s ability to withstand varying environmental conditions during use, storage and distribution.

Temperature, Humidity, Ingress Protection, Drop Test, Sweat Test, Accelerated and Realtime Aging

Conduct rigorous mechanical assessments to verify the structural integrity, durability, and performance of your device under stress and wear.

Tensile test, Hardness Test, Pull Test

Evaluate the security of device to identify vulnerabilities and ensure compliance with cybersecurity requirement.

CSA-CLS MD, VAPT, IEC 60601-4-5, ISO 81001-5-1, FDA Guidance

Perform comprehensive assessments to protect users from electrical risks and ensure alignment with national and international safety standards.

RM files, Critical Components, IEC 60601, IEC 61010, IEC 62304

Assess device free from microbiological contamination and chemical toxicity to ensure safety for both users and the environment.

Endotoxin, Bioburden, Sterility, Toxic Chemical Substance, REACH, RoHS, PFAS

Monitor and assess environmental conditions in controlled areas.

Cleanroom, Surface, Air Monitoring, Water Monitoring

Perform testing and verify the environmental impact throughout the device lifecycle, from material selection, production to end-oflife.

LCA, PCF, Recycle Content Verification