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Part 3: Are You Ready - Testing and Certification Process

Prepare for your medical device evaluation and testing process.

February 11, 2021

Welcome to UL’s third installment of “Are You Ready for Your Testing and Certification Process?” where we will discuss ways to make your testing and certification process easier.

In previous issues, we discussed planning for compliance in order to have the correct items ready for submission and the five key items that you can start preparing early to get your project started. This month we’re discussing the actual product evaluation. You have provided all the requested information and product samples to the laboratory for testing. You are excited to start the project and get everything moving, but what happens next with your project? Below are the main steps of the process.

Project assignment

Once you have submitted all the requested items, your project will be assigned to a project handler (PH). The PH may or may not be the same person that provided the project scoped. Once the PH is assigned, they will contact you and will serve as your main contact for the duration of you project. The PH will provide you with all the details, clarify project specifics and answer any questions you may have.

It is important that you let your PH know your preferred method of communication (email, phone, text, etc.) and how often you want to receive updates. As a UL customer, you will have access to the latest status of your project through UL’s full-service client portal.

Initial review of construction/documents

Your PH will begin reviewing the information and product sample provided. During this phase, the PH will start drafting the report. Throughout the report development, both the product and documentation will be reviewed against the requirements of the applicable standard(s). Additionally, the test datasheets will be drafted. At any point during the review, your PH may contact you for clarification on construction, intended use, functionality and other items.

After completing a the first portion of the evaluation — reviewing all clauses from the relevant standard(s) — your PH may have additional comments, questions, or a list of potential noncompliances. A discussion with your PH will help you better understand the requirements and provide answers to any questions you may have.

Depending on the clarifications or information needed, the project may proceed with testing. However, if any of the items requires changes to the construction of the product, your PH will discuss other options, including waiting on testing. This discussion will be critical in determining the path forward. If modifications are needed, repeat testing may be deemed necessary. Regular communication and collaboration with your PH are key to assure the project stays on track

Product testing

During the initial review, your PH will begin the discussion around testing (determining worst case operation, noting tests that require special setups or tests that require specialized equipment). Testing will begin after all the construction items and necessary information for testing is determined. The testing can take a couple of days to weeks depending on the complexity of the device and standard(s), which is typical for medical standards such as IEC 60601-2-16 (Hemodialysis Equipment). This standard includes Essential Performance testing that can take days to complete due to the complexity and duration of testing. Certain standards may also require specialized testing that can only be conducted at a customer’s site, such as tests involving blood, as noted in IEC 60601-2-16.

During the scoping discussion, more than one sample is typically requested for testing and evaluation. Sometimes testing is destructive, and sample availability can significantly delay testing. Your PH is always available to discuss the test plan and which tests may be more destructive.

During testing, your assistance may be needed in keeping your product functioning, which makes spare parts and additional samples critical for the prevention of potential delays. Alternative options may be available to prevent or minimize damage to expensive parts of the sample unit. For example, when testing a handheld dental scanner and performing the drop test of Clause 15.3 of IEC 60601-1:2005+A1:2012 on its handheld wand. This test can break sensitive internal parts of the optics/camera in the wand. If the unit does not require Essential Performance, it may be possible to test with a nonfunctioning optics/camera and still confirm the basic safety of the device as a whole.

Continuing the testing process

Your PH will contact you if any assistance is needed throughout testing. A project may cycle between steps 2 and 3 as issues are encountered and addressed during the evaluation and testing. Continuous communication and collaboration between the PH and customer are critical so our experts can help guide you through this portion of the evaluation and beyond.

The testing and certifications process includes a few more steps before completion. Next month, Part 4 of this series will discuss what lies ahead along the path to completion.

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