Medical product safety, performance and quality paradigms are shifting as devices become more interoperable, hospital environments become more complex and digital health technologies proliferate. Only through third-party testing and certification can manufacturers demonstrate claims of safety, quality and performance for their products, even as they innovate.
Deliver safer, higher-performance medical devices by meeting regulatory requirements and industry standards.
Use testing and regulatory certification results to reach users and patients globally with confidence.
Meet EMC regulations and mitigate risks of electromagnetic interference.
We offer biocompatibility testing, chemical characterization, microbial ingress and cleaning validation services to help manufacturers demonstrate compliance and gain access to global markets.
We conduct independent, rigorous testing and certification of medical devices to help manufacturers demonstrate safety and performance claims according to regulatory requirements and industry standards.
We provide independent assessment of health and life sciences companies’ QMSs to verify compliance to the ISO 13485 standard for medical device quality management systems. ISO 13485 certification is required by regulators in many markets.
We offer testing and certification for software as a medical device (SaMD) according to industry standards including IEC 82304-1, IEC 60601-1 part 14 and IEC 62304, which can help demonstrate SaMD safety and quality.
In environments where electromagnetic interference poses risks to patients, we provide electromagnetic compatibility (EMC) testing and certification to help demonstrate conformance to the IEC 60601-1-2 standard for safety and essential performance.
We offer medical device packaging validation and stability testing according to standards such as ISO 11607-2:2019 for packaging terminally sterilized medical devices. Our testing covers seal integrity, sterility, qualification of packaging materials, air permeability and more.
Our testing and advisory services help customers demonstrate compliance to requirements such as the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) and Restriction of Hazardous Substances (RoHS) regulations.
“Together, we create solutions that help Medtech innovators ensure essential technologies reach the market safely and effectively.”
A select list of predominant medical device standards UL Solutions tests against.
The market for home healthcare is growing as service delivery shifts from clinical to home settings. Manufacturers face challenges in supplying equipment that is both more effective and safer.
In this white paper, we cover in detail the requirements per Ordinance no. 384:2020 to achieve and maintain INMETRO Certification under UL Solutions.
The standard introduces electromagnetic (EM) environments of "intended use", including professional healthcare facilities and home healthcare.
Successfully introducing on the market an advanced medical wearable device: Sidly case study.
Our on-demand webinar covers the U.S. FDA’s Accreditation Scheme for Conformity Assessment (ASCA) program to boost confidence in device testing.
Our safety science expertise and software enable industry innovators to streamline market access, manage cybersecurity risks, build a compliant workforce, enhance supplier risk management and strengthen ESG management capabilities, helping them develop safer and compliant medical products and systems. Download our brochure to learn more.
Leverage our testing and certification.
* Within UL Solutions we provide a broad portfolio of offerings to all the medical device industries. This includes certification, Approved/Notified Body and consultancy services. In order to protect and prevent any conflict of interest, perception of conflict of interest and protection of both our brand and our customers brand, we have processes in place to identify and manage any potential conflicts of interest and maintain impartiality. UL Solutions is unable to provide consultancy services to EU MDD, MDR, IVDD or IVDR Notified Body, UKCA MD Approved Body or MDSAP Customers.
