Recognize and maintain safety in medical device design
Understanding the applicable standard requirements and incorporating them into your device during the design stage can help curb potential delays, reduce potential medical device use error and help to ensure your devices function as expected. UL's Early Engagement Design and Feasibility testing helps medical device manufacturers meet required regulatory and safety standards.
Standards and regulatory requirements
We provide testing to standards and your specifications to support you in your drive to get safer, compliant medical devices to market as quickly as possible.
Our offerings include testing for:
- Medical electrical equipment
- IEC 60601-1 series of standards (collaterals and particulars)
- Laboratory equipment
- Evaluation to IEC 61010-1 series of standards (particulars)
In addition to providing testing services for new technologies in advance of standards being published, UL also offers customized testing for your medical devices for other standards, including:
- Association for the Advancement of Medical Instrumentation (AAMI)
- American National Standards Institute (ANSI)
- International Organization for Standardization (ISO)
Our global footprint allows us to evaluate and create individualized procedures to properly evaluate your medical devices. UL will also create custom reports based on these tests to present the data in formats that meet your documentation needs.