Medical Device Safety and Compliance

The growing complexity of medical devices requires more advanced testing and certification to verify safety, performance and compliance to regulatory requirements. UL examines some emerging safety considerations and several applicable standards for market compliance. By developing a comprehensive testing strategy, manufacturers of medical devices can streamline testing and certification, save money and simplify compliance.

To help patients, healthcare products need to be available. However, before these products are sold, they need to demonstrate safety and effectiveness. As the healthcare industry adapts to connected and evolving technologies, safety standards are always being updated. This makes new types of safety testing a must for today’s healthcare products.

Medical device manufacturers, developers and standards authors all look at the same safety issues when it comes to:

• Patient care
• Information access 
• Data security 
• Product safety 
• Result reliability 

The above considerations are all aiming at one goal: patient safety.

Elements for evaluation

Safety and testing services often prioritize constructional requirements, type tests, risk management evaluations and quality management support for healthcare devices. These evaluations will examine products and facilities for:

• Electrical safety and performance
• Electromagnetic compatibility (EMC)
• Wireless testing, coexistence and Global Market Access support
• Biological evaluation, biocompatibility, microbiological tests and sterilization services
• Cybersecurity
• Interoperability
• Customized testing and validation services

These tests offer robust reporting that can lend insights into better product safety requirement discovery and management.

Confidence through compliance

Regulatory compliance for medical devices is difficult to navigate. Manufacturers, developers and end users often need assistance to stay on top of the latest standards to keep their products compliant. As an example, the list below includes several important standards, all of which fall within UL’s testing and certification capabilities:

• IEC/AAMI 60601-1, Medical Electrical Equipment – General Requirements for Basic Safety and Performance plus related particular and collateral standards
• UL 2900, the ANSI/CAN/UL Standard for Software Cybersecurity for Network-Connectable Products
• UL 2560, the Standard for Emergency Call Systems for Assisted Living and Independent Living Facilities
• UL 1069, the Standard for Hospital Signaling and Nurse Call Equipment
• UL 1431, the Standard for Personal Hygiene and Health Care Appliances
• IEC 61010-1 Safety Requirements for Electrical Equipment for Measurement, Control, and Laboratory Use, plus other related standards
• ISO 14971 Medical Devices – Application of Risk Management to Medical Devices
• ISO 13485 Medical Devices – Quality Management Systems — Requirements for Regulatory Purposes

Compliance and safety solutions

UL’s global reach and local presence energizes us to deliver innovative, customized solutions to streamline testing and simplify the compliance process. With engineers and laboratories worldwide, we provide localized testing and certification to cover international standards though the Americas, Europe, Asia Pacific and more.

We can tailor testing to your particular specifications, as well as offer expert advice to help ensure the most efficient use of your time and budget. Leveraging our expertise during the development process can help you avoid costly errors in the design phase and speed time to market. 
Arm yourself with additional information and resources to prepare your medical products for compliance with additional resources from UL.