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Medical Device Regulatory Testing and Certification

A complete offering of third-party regulatory services for medical device manufacturers

Male nurse checking medical device

Overview

UL provides active and inactive medical device manufacturers with a complete offering of third-party regulatory approvals, product testing and certification, auditing, cybersecurity testing, usability testing, and the training to support your compliance challenges.

Services

Validation/ Verification Report – UL determines the accuracy of marketing claims related to the performance, functionality or features of products, facilities, processes and systems that consumers or end users are unable to easily assess on their own. Our claim verification service is based on rigorous, repeatable and independent assessments. Companies that successfully have a claim verified by UL are eligible to use the specially created UL Verified Mark to showcase that their claim is backed by an objective, science-based process leveraging our trusted technical expertise and capabilities.

Summative Test Report – Plan, conduct, and report the results of a summative (i.e., validation) usability test of the market-ready product to validate that it meets the user requirements and ensures safe and effective use. Summative usability tests can be designed to meet applicable regulatory requirements (e.g., ONC safety-enhanced design requirements; or in support of FDA submission and/or CE marking).

Human Factors Engineering Report – UL works with our clients to establish a guiding vision of how the intended users (e.g., healthcare professionals, administrative personnel, and patients) will interact with a product and conceptualize all of the touch points that will contribute to the full user experience.

Cybersecurity Assessment Report – Will help identify assets, threats, and vulnerabilities and assess of the impact of threats and vulnerabilities on the device functionality and end users/patients and assess the likelihood of a threat and of a vulnerability being exploited. Performing this analysis will help to improve the cybersecurity hygiene of your product that will meet industry best practices that align with HDO expectations, UL 2900, NIST framework and TIR-57.

Informative Test Report – For many countries and/or regulatory bodies, an informative test report may be all you need. UL can assist by performing the evaluation to EN (European Norm) or other appropriate standards and issue an informative test report. Though a third-party report may not always be required, it may be desirable to mitigate risk, liability and can be used as market differentiator.

Certified Body (CB)

With over a century of experience in safety science, UL is uniquely positioned to support manufacturers of laboratory, test, and measurement and control equipment.

We offer a full suite of services aimed at helping our customers communicate compliance to the applicable standards and the suitability of their devices for security and use in electrical labs, scientific research labs and factory automation.
As the top NCB under the IECEE CB Scheme category for laboratory and test and measurement equipment, “MEAS”, customers can use the UL CB test report and certificate to receive multiple global certification marks, many of which UL can deliver directly. We can provide integrated test plans that encompass multiple national requirements, reducing rework for global requirements. Simply put, we can test your product in our laboratories to the IEC UL 61010 standard and you can receive approval to use the UL NRTL mark, receive an IECEE CB Test Certificate and even fulfill other local country requirements such as GS and D marks.

IECEE: Why it is important?
  • Safety: Manufacturers/suppliers must ensure that their products comply with relevant safety standards, while government regulations are generally intended to protect populations from potential risks associated with products.
  • Quality: Buyers/wholesalers want to ensure the quality of products purchased and unhindered market access.
  • Interoperability: Product manufacturers and end users want to be sure their products work and can interact with other products, services and installations.
  • Consistency: Manufacturers/suppliers want to be sure their marketed products comply with the sample assessed.

Nationally Recognized Testing Lab (NRTL)

In the USA and Canada, virtually all electrical products must undergo some form of conformity assessment (testing, inspection, product certification) so that acceptance interests (federal, state, and local regulating authorities; retailers; distributers; consumers, etc.) have confidence that the product meets relevant safety and other requirements.

OSHA is the U.S. federal regulating authority for U.S. workplace environments. OSHA demands product safety certification for some (not all) of the workplace products that come under the scope of its regulations. OSHA only requires certification for end products. In order for these product certifications to fulfill OSHA regulatory requirements the certifications must be issued by a Nationally Recognized Testing Laboratory (NRTL) (like UL) formally recognized by OSHA.

Services

The UL (US) and cUL (Canada) Marks are two of the most commonly recognized and accepted NRTLs certification marks in North America. They “set the standard” and are regularly accepted by authorities having jurisdiction, inspectors and others. They provide a strategic marketing advantage to our customers who value quality and integrity.

In addition to traditional NRTL certification services, UL offers a straight-forward way to convert from another NRTL certification mark to UL. It is as simple as giving UL your current test report (including test data), a sample and your risk management file (if applicable). UL expert engineers will review the data for scope, potentially conduct test checks and if all is in compliance with the appropriate standard, UL will transfer your file and you can start to place the UL Certification Mark on your product immediately.

Quality Management System (QMS)

A quality management system is critical to ensure your medical product will be manufactured to your specifications for safe intended use every time. And for medical devices, in most cases, it is a regulatory requirement as well. With every product submission, the regulatory bodies require proof that your product has been manufactured under a certified quality management system.

As an accredited registrar under ISO 17021 we certify you against ISO 13485, UL wants you to succeed, both as a quality professional and as a medical business. We employ full time, experienced auditors who can add real business value to your operation and work with you until your action requests are resolved.

QMS – ISO

Our ISO 13485 program is accredited by UKAS. UL remains current with existing and emerging international standards through its participation in IEC SC62A, IEC SC62, IMDRF, MDSAP forums, NB:MED and IAF ISO 13485 MDCAS Working Group.

Our team includes full time auditors located around the world, in your time zone who can speak your manufacturer’s local language. And with UL, you can schedule integrated audits of your management system to take advantage of the similar requirements synergy among your various management system needs, including ISO 13485, ISO 14971, MDSAP, EU Notified Body, Brazil INMETRO and more.

Services
  • Preliminary evaluation – A practice or audit of your site to determine your readiness for a registration audit. You will receive a written report including a list of any non-conformities found.
  • Registration assessment – Typically scheduled two to four months after your preliminary evaluation. At the conclusion of the registration assessment, your UL audit team will advise you of its recommendation and present a written non-conformity report before leaving the site.
  • Continuous assessment – Conducted after registration to measure your continued conformance to the ISO 13485 standard.
  • Triennial (recertification) assessment – Recertification assessment to begin a new 3-year cycle of registration.
  • Internal audits and training – For manufacturers who do not have certification with UL, UL experienced auditors can conduct your internal audits and training. Once UL auditors provide internal audits and/or training, the manufacturer must wait 2 years until UL can be its certification body. UL also offers ISO 13485 training courses through UL Knowledge Services.

Medical Device Single Audit Program (MDSAP)

What is MDSAP and where does it apply?

The intent of the Medical Devices Single Audit Program’s (MDSAP) is to allow manufacturers to meet the quality management system (QMS) for participating countries with a single QMS audit. The program is based on the International Medical Device Regulators Forum (IMDRF) program documentation and countries that are currently participating are: U.S. FDA, Health Canada, Australia Therapeutic Goods Administration (TGA), Japan Pharmaceuticals and Medical Devices Agency (PMDA), and Brazil National Health Surveillance Agency (ANVISA).  

The MDSAP Benefits for Device Manufacturers

For the medical device industry, the MDSAP is expected to significantly reduce the audit compliance challenges facing device manufacturers. Specific benefits of the MDSAP include:

  • Harmonization of auditing requirements
  • Broader acceptance of audit reports
  • Reduced overall auditing time and expense
  • Reduced time responding to findings
  • Wider choice of 3rd party audit organizations
  • More transparent and consistent oversight by regulators
Services

Similar to other management system audit programs, the MDSAP is based on a three-year audit cycle conducted in accordance with the requirements of ISO/IEC 17021:

  • Stage 1 Initial certification Audit – Review of documentation and overall preparedness. Typically includes a review of the planning documentation.
  • Stage 2 Initial certification Audit – Evaluate QMS compliance to ISO 13485, as well as other requirements of MDSAP-participating regulatory authorities.
  • Surveillance audits – Surveillance audit is conducted annually to also assess any changes in the manufacturer’s products or QMS processes since the initial certification audit.
  • Recertification audit – In the third year to evaluate a manufacturer’s QMS for its continued suitability and effectiveness in meeting QMS requirements under the MDSAP.
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