Medical Device Safety Testing
Element's Medical Device Safety Testing services provide end-to-end support from design to certification, accelerating your time-to-market while navigating complex regulations. Our hands-on technical guidance ensures your devices meet global safety standards with single-location testing that reduces costs and streamlines your verification process – delivering safe, compliant products faster.
What is medical device safety testing at Element?
Medical Device Safety Testing verifies that healthcare products are safe for use, reliable in operation, and compliant with stringent international regulations before market release. At Element, we provide comprehensive electrical safety testing and certification services to help manufacturers identify appropriate safety testing standards and remove both cost and risk out of the product certification and validation process. We are fully compliant with medical safety standard IEC 60601-1, which is recognized by public health authorities in most countries and is the harmonized standard under the Medical Device Directive 93/42/EEC.
What can Element offer you for medical device safety testing?
Products we test
Products we test
Element provides comprehensive testing services for all types of electrical medical devices and their components. Our experts work with you to define testing requirements based on your specific device classification, usage environment, and target markets, ensuring your product meets all necessary safety standards for global distribution.
Key tests offered
Key tests offered
We offer a full suite of safety testing to the IEC 60601 standard, which covers essential safety and performance requirements for medical electrical equipment. Our testing evaluates:
- Electrical safety
- Mechanical robustness
- Thermal performance
- Protection against hazards across various operating conditions
Our expertise extends to specialized testing for cardiac equipment, nerve stimulators, home healthcare assessments to support IEC 60601-1-11, and diagnostic monitoring systems.
Methods and solutions offered
Methods and solutions offered
Our safety experts provide end-to-end support including compliance strategy development, pre-compliance testing, formal certification testing, and documentation preparation. We offer:
- Bespoke and one-to-one training
- Documentation and procedure review
- Production of essential documentation
- Mentoring through retainer contracts to ensure continuous compliance
We also provide essential early-stage product development support, helping determine applicable standards, assessing design specifications, and implementing effective risk management from the beginning of your project.
Which labs offer this service
Which labs offer this service
Element operates specialized medical device testing laboratories that are fully UKAS accredited to BS EN ISO/IEC 17025:2005 as National Certification Bodies (NCB) and Certification Body Test Laboratories (CBTL) under the IECEE's Worldwide System. Our global network includes CB Scheme testing laboratories in the UK, US, Germany, and China, ensuring your testing needs can be met efficiently, wherever your target markets may be.
Risk management expertise
Risk management expertise
We understand that risk management according to ISO 14971 is a mandatory requirement when demonstrating compliance to the EN/IEC 60601-1 3rd Edition. Without this documentation, compliance is not possible, regardless of your device's physical and electrical safety characteristics. Our specialized team provides comprehensive support with risk management documentation, helping you develop robust processes that not only achieve compliance but strengthen your product safety profile. This includes gap analysis, remediation strategies, and complete technical file compilation and review.
Standards we test to and products we test
- Electrical medical devices
- Medical equipment
- Healthcare monitoring systems
- Therapeutic devices
- Diagnostic equipment
- Cardiac monitoring equipment
- Infusion pumps
- Ultrasonic diagnostic devices
- Blood pressure monitoring equipment
Your Challenges, Our Solutions
Complex Regulatory Compliance
Delayed Time-to-Market
Risk Management Hurdles
Documentation Management Challenges
Why Choose Element
Global Recognition
Single-Supplier Testing
Risk Management Specialists
Full Classification Support
Related services
Medical Device Regulatory Services
Element offers expert medical device regulatory consulting, guiding you through design, risk analysis, and FDA submissions for efficient product approval.
IEC 60601 Medical Device Safety Testing services
Element provides testing and certification to IEC 60601 to assess the safety and essential performance of electrical medical devices.
Frequently asked questions
What makes ISO 14971 so critical for medical device compliance?
ISO 14971 risk management is a mandatory requirement when demonstrating compliance to the 3rd Edition of EN/IEC 60601-1. Without proper risk management documentation, achieving compliance is impossible, regardless of your device's physical and electrical safety characteristics. Element's expertise helps you develop and maintain this critical documentation.
How does Element help manufacturers export devices globally?
Our status as both a National Certification Body and CBTL under the IECEE's Worldwide System means our testing and certification are recognized internationally. This allows you to test your product with a single supplier, eliminating redundant testing requirements across different markets and streamlining your global market entry strategy.
What support does Element offer to startups developing medical devices?
Element provides specialized guidance to startups during the early stages of medical device development. Our experts help identify applicable standards, develop regulatory strategies, and implement effective risk management processes, ensuring that barriers to market entry are addressed as early as possible.
