Medical Devices
Medical Device Testing Laboratory
Confidence in Every Clinical Decision
Independent testing for medical device safety, accuracy, reliability and regulatory compliance, helping manufacturers protect patients and prepare products for global markets.
Medical Device Validation Console
Test Sequence Active
Patient Monitor Accuracy Simulation
Channel 01
72
Heart Rate
98%
SPO2
120/80
Pressure
Accuracy and Repeatability
99.2%
Accuracy
Reference Points
24
Repeat Cycles
120
Deviation
0.8%
Infusion Performance
5.0
Flow rate, millilitres per hour
Accuracy
Pass
Patient Safety Focused Evaluation
Clear evidence for engineering and compliance teams.
Safety First
Electrical, mechanical and performance risks evaluated in one structured programme.
Safety Evaluation
Electrical and mechanical risk assessment.
Performance Validation
Accuracy, functionality, reliability, and durability validation.
Environmental Testing
Temperature, humidity, vibration, and environmental stress simulation.
Global Compliance
Support for recognised regional and international standards.
Why Testing Matters
Medical devices influence diagnosis, therapy, monitoring, and continuous patient care.
Why Medical Device Testing Is Essential
Safety, Accuracy and Reliability Are Paramount
Medical devices play a critical role in healthcare. Rigorous testing helps verify that products operate safely, perform accurately, and remain reliable under expected conditions.
METS Laboratories supports manufacturers with independent evaluation that safeguards patient health and helps prepare devices for access to global markets.
Identify electrical and mechanical safety risks
Validate accuracy, functionality and durability
Evaluate resilience under challenging conditions
Support certification and market access
What We Test
Medical Technologies Across Clinical and Home Care Settings
Testing programmes are tailored around device function, intended use, risk profile and target market.
01
Patient Monitoring Devices
Blood pressure monitors, pulse oximeters, ECG systems, vital signs monitors and related equipment.
02
Imaging Systems
MRI, CT, ultrasound and associated imaging equipment requiring safety and performance assessment.
03
Therapeutic Devices
Infusion pumps, ventilators, dialysis machines and other equipment used to deliver treatment.
04
Surgical Equipment
Endoscopy systems, surgical lights, electrosurgical units and supporting clinical equipment.
05
Diagnostic Tools
Glucose meters, haematology analysers, point of care devices and diagnostic instruments.
06
Wearable and Home Healthcare
Smart health trackers, portable ECG products, hearing aids, nebulisers and oxygen concentrators.
Testing Capabilities
One Coordinated Programme, Multiple Layers of Assurance
The exact test scope depends on device classification, construction, applied parts, essential performance, and intended sales region.
Safety Evaluation
Assessment of electrical, mechanical, and foreseeable use related hazards that may affect patients, operators, or surrounding equipment.
Leakage Current
Dielectric Strength
Protective Earth Continuity
Temperature Rise
Mechanical Stability
Abnormal Operation
Performance and Accuracy
Verification that the device performs its intended function with consistent, repeatable, and clinically relevant results.
Measurement Accuracy
Functional Verification
Repeatability
Flow and Pressure
Alarm Functions
Durability Cycles
Environmental and Mechanical
Simulation of storage, transport, and operating conditions that may influence safety or essential performance.
Temperature Exposure
Humidity
Vibration
Mechanical Shock
Ingress Protection
Transport Simulation
Compliance Support
Structured reporting and technical guidance aligned with relevant medical device standards and quality documentation.
IEC 60601 Series
ISO 13485
ISO 14971
Technical File Support
Design Verification
Global Submissions
Standards and Frameworks
Recognised Requirements Translated Into a Practical Test Plan
The final scope is selected according to the product, applied parts, intended use and destination market.
Recognised Standards and Methods
Relevant requirements are selected around device design, performance, risk and intended clinical application.
IEC 60601
Basic safety and essential performance for medical electrical equipment.
IEC 60601 1 2
Electromagnetic disturbances for medical electrical equipment.
ISO 13485
Quality management framework for medical device organisations.
ISO 14971
Application of structured risk management to medical devices.
Environmental Methods
Temperature, humidity, vibration and mechanical stress methods.
Product Specific Parts
Particular requirements selected according to device function.
From Early Design Verification to Market Readiness
METS Laboratories helps organise test evidence around your development stage and regulatory objective.
01
Pre Compliance Review
Identify likely evidence gaps before formal evaluation.
02
Design Verification
Confirm applicable safety and performance requirements.
03
Formal Laboratory Testing
Generate controlled testing records, findings and results.
04
Technical Reporting
Support certification, review and submission pathways.
Our Testing Process
A Clear Route From Device Review to Final Report
A structured workflow keeps the programme transparent and aligned with your product development schedule.
Step 01
Requirement Review
We confirm device function, intended use, target standards, applied parts, classification, and market objectives.
Scope ConfirmationStep 02
Test Plan and Samples
Our team defines the scope, sample configuration, supporting documents, applicable methods, and laboratory sequence.
Sample PreparationStep 03
Laboratory Evaluation
Testing is performed with controlled measurements, documented observations, technical evidence, and traceable results.
Controlled TestingStep 04
Reporting and Support
You receive clear results, findings, technical documentation, and practical guidance for the next compliance action.
Final DocumentationPartner With METS Lab
Trusted Testing Support for Safer Medical Products
METS Laboratories helps manufacturers verify that medical devices are safe, reliable, and aligned with international requirements, supporting product development and market readiness.
Start Your Testing ProjectPatient Safety Focus
Testing addresses electrical, mechanical, thermal, and foreseeable use hazards that may affect patients, users, and operators.
Performance Confidence
Accuracy, functionality, repeatability, reliability, and durability are assessed under clearly defined conditions.
Global Compliance
Test evidence and technical reporting support certification requirements for regional and international markets.
Broad Device Coverage
Support spans imaging, monitoring, surgical, therapeutic, laboratory, and home healthcare products.