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New and Altered Medical Devices and Products

Expedited support for medical device and product manufacturers for launching new or altered products to help combat COVID-19.

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New emergency-use provisions in the U.S., Europe and other regions are allowing manufacturers of ventilators, personal protective equipment (PPE) and other products expedited market access; but quality, safety and performance requirements must still be met.

We now offer accelerated and virtual options for many of our routine healthcare product testing and inspection services to help manufacturers successfully and safely address supply shortages. Our experience enables us to streamline the go-to-market process for re-engineered products that include new features or health benefits to meet emerging needs stemming from the pandemic.

Our comprehensive service offerings span the entire production cycle, with early-stage reviews to clarify applicable safety standards and regulatory requirements, performance and safety testing, product certification and global market access services. 


Early engagement

Early engagement design feasibility testing

UL's Early Engagement Design and Feasibility testing helps medical device manufacturers meet required regulatory and safety standards.

Human factors engineering and testing for combination products

Take precautions to minimize human error and demonstrate compliance to local and harmonized global regulatory standards for medical devices used in drug delivery.

Assess expected level of clinical/usability and risks

Users must be able to operate medical devices safely and effectively. UL’s full life-cycle usability testing services meet medical device manufacturers' regulatory, standards certifications and marketing requirements.

Certification of materials for 3D printing

Materials used in 3D printing do not perform the same as with traditional manufacturing processes. To ensure the performance, UL will test, validate and issues certifications for plastics used in additive manufacturing.


Regulatory and product compliance

Plastic materials testing

UL can provide the assurance you need with safety and performance testing to quickly validate that your existing materials or material substitutions for use in medical devices comply with regulatory and safety standards.

UL Standards offers free document access

Underwriters Laboratories, UL’s nonprofit affiliate, identified 23 of its Standards that can help to fight COVID-19. Learn more—including how to access the documents for free—at UL.org.


Sterilization

UV photobiological testing

With the influx of UV sterilization products to the market, UL evaluates the photobiological safety of UV light sources to understand the risk group classifications of these devices and help ensure they are within specified exposure limits.


Certification and finished product testing

Expedited and remote witness testing

Expedited and remote services designed for safety and compliance testing of critical equipment used in laboratory, manufacturer and healthcare settings.

Electrical and mechanical safety testing to IEC 61010-1 and IEC 61010-2-101

Specialized services designed for the safety and compliance of equipment used by laboratories, manufacturers and healthcare providers.

Field inspection for modification of a certified product

Remote inspections to support modifications to a UL certified product such as alternate manufacturing site, alternate component or other key changes.

INMETRO certification

Certification and factory inspections for electro-medical devices in Brazil, helping manufacturers meet registration requirements for the Brazilian market.

IVDs and companion diagnostics testing and certification

Testing and certification solutions to help you commercialize high-risk classification diagnostic tests intended to directly inform patient treatment programs.

Medical device packaging testing

Testing to evaluate the performance of the packaging system, aseptic presentation and microbial barrier properties, as well as the performance of the containing medical device, functionality and biocompatibility.

Medical device regulatory testing and certification

Suite of product testing and certification, auditing, cybersecurity and usability testing and training to help medical device companies meet compliance requirements around the world.

Medical Device Single Audit Program (MDSAP)

Satisfy regulatory requirements in the U.S., Canada, Brazil, Australia and Japan with a single quality management system (QMS) audit report. 

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