SETSCO Services for Medical Devices
From Concept to Compliance, Your Solution Partner
Conceptual and Planning
- Advisory
- Training
Pre-compliance Testing
Perform document and construction review at early phase of your product design.
RM files, Critical Components, IEC 60601, IEC 61010, IEC 62304
Calibration and Measurement
Perform calibration on equipment used in manufacturing and laboratories to ensure precision and accuracy of equipment.
Dimensional, Force, Flow, Pressure, Electrical Parameter, Temperature, Humidity.
Environmental Simulation
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
Mechanical and Physical
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
Cybersecurity Testing and Assessment
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
Electrical Safety Testing
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
Microbiological and Chemical
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
Environmental Monitoring
Monitor and assess environmental conditions in controlled areas.
Cleanroom, Surface, Air Monitoring, Water Monitoring
Sustainability
Perform testing and verify the environmental impact throughout the device lifecycle, from material selection, production to end-oflife.
LCA, PCF, Recycle Content Verification
Electromagnetic Compatibility Testing (Lab and On-site Testing)
Evaluate whether the device operates without causing or being affected by electromagnetic interference in its intended environments.
Radio Frequency Testing
Evaluate the performance, compliance, and interference characteristics of devices that transmit or receive radio signals across designated frequency ranges.
Packaging and Transportation Simulation
Assess the ability of packaging and products to endure the physical and environmental stresses encountered during shipping and handling.
Acoustic Testing
Measure parameters like active and passive noise cancellation sound level measure send and receive loudness rating.
We journey with you throughout your product life cycle
Conceptual and Planning
- Advisory
- Training
Research & Development
- Construction Review
- Pre-compliance testing
- Documentation review
- Material testing
Compliance & Regulatory Submission
- Full compliance testing (IEC, ASTM and etc.)
- Usability evaluation
- Cybersecurity
- Process validation
- Validation testing – environmental simulation testing
- Aging testing
- Sustainability
Product Launched and Mass Production
- Inspection
- Environmental monitoring
- Routine testing
- Calibration