What to Consider When Choosing Your Testing Partner

Choosing the Right Testing Partner

When it comes to selecting a testing partner, how do you make your choice?

It might be through an existing relationship, a recommendation from a trusted colleague, or even a simple Google search. Regardless of the method, it’s crucial to ask the right questions and verify their credentials. Equally important, though, is getting a good feeling from the team you interact with – trusting not only their technical expertise but also their customer service.

So, where do you start?

Accreditations and Certifications

Accreditations are perhaps the most critical factor. Without the right quality management systems in place, you could face pushbacks from your Notified Body before they even evaluate your report. The appropriate Quality Management System (QMS) depends on two things: the market where you intend to sell your product and the type of testing required. For the UK and EU, ISO 17025 accreditation is generally sufficient. However, if you’re targeting the US market, you’ll likely need a laboratory with GLP certification. For specific types of analysis, like biocompatibility testing, it’s essential to use a GLP-certified lab to ensure FDA acceptance of your testing report.

Geographical location is also important – not just where you want to sell your product, but also where the laboratory is located. For instance, the FDA issued a letter to industry in February 2024 expressing concerns about reports from some Chinese and Indian laboratories due to issues with fraudulent documentation. While labs in these regions might offer financial savings upfront, you could end up paying more in the long run if your Regulator rejects the reports and requires you to repeat the testing.

Turnaround Times

Testing often comes at the end of the development process, but it’s wise to consider your testing partner earlier on. Finding the right partner can take time, especially if you’re comparing multiple quotes. Some labs can provide a quote within 24 hours, while others may take 2-3 weeks. At Test Labs, we understand how frustrating delays can be, particularly when time is critical – like during an MDR transition when Notified Bodies might have already flagged missing or incomplete data. Providing a prompt quotation helps our customers get internal approvals quickly and move forward without unnecessary delays.

However, getting the quote is just the first step. Securing a testing slot is another challenge. Depending on the project, testing can take weeks or even months, and lab schedules might be booked 3-6 months in advance. It’s important to clarify this during your selection process. We’ve even had situations where we delivered test results before a competitor had even sent their quotation!

Customer Service

Trusting a lab with your testing can be daunting, especially if you’re new to the process or working with a provider for the first time. It’s crucial to feel comfortable with the team before starting your project. In my experience, if a provider is slow to send a quote or hard to reach during the initial stages, it doesn’t usually bode well for the actual testing phase when you might have questions or need updates.

Building rapport with the lab is important, as medical device testing is often complex, and you’ll likely need support along the way. Good customer service means not only having a good relationship with the sales team but also having access to technical experts. Does the provider allow open communication with the lab team? Can you visit the lab to see where your samples will be tested? These interactions build your confidence in the provider and ensure a smoother testing process.

Understanding your report

Producing a high-quality report that satisfies a Regulators is crucial, but it’s also important to remember that these reports may be used beyond regulatory submissions. Manufacturers often use testing reports in the sales process, where customers may review them to assess product superiority or as part of marketing efforts.

It’s essential that our customers fully understand the contents of their reports and feel confident in explaining the results. Whether the report is for a notified body or as part of the sales process, fully understanding what the data means and how it enhances your product’s value is equally important

Choosing the right testing partner is key to your product’s success. Beyond accreditations and certifications, your partner must meet timelines, offer excellent customer service, and provide clear, thorough reports. Ultimately, the ideal partner should not only fulfil technical needs but also align with your values, ensuring a smooth, supportive process from start to finish.

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