Here are the four main benefits of hiring experts to test and evaluate your medical device. If the lab you’re considering cannot provide these benefits, you should consider expanding your selection until you find the one that can deliver:
As soon as you have a device concept in mind, you should start engaging with your third-party test laboratories. Many expert labs offer evaluation services that can help you identify issues with your design even when all you have are renderings.
Let’s revisit that clinical thermometer we spoke about earlier. A good lab with experienced personnel can identify many potential non-conformities within minutes of seeing your device, such as:
Some of the best, most productive meetings I’ve had with clients happened early in the design phase. That’s because:
If you select your third-party test laboratory through an internet search and focus on cost, you might be setting yourself up for failure. Instead, base your search on these questions:
Accreditation is an independent assessment by a third party that confirms the lab operates within a quality management system, knows what it’s doing, and can prove its findings with objective evidence.
Accreditation by a third-party lab, such as A2LA, is a higher standard than the conformity assessment standards (ISO/IEC 17025, General Requirements for the Competence of Testing and Calibration Laboratories) alone. That’s because the requirements part of the process is more than just an assessment against ISO/IEC 17025. It also includes additional requirements related to measurement traceability, proficiency testing (inter- and intra-laboratory comparison), and general requirements, including special requirements in specific fields.
After you’ve verified the lab you’re considering is accredited, you need to review its scope of accreditation to determine if the testing you’re requesting is within the lab’s scope. Using the clinical thermometer as an example, one standard you must comply with is ISO 80601-2-56, an electrical safety testing standard, particularly for clinical thermometers.
So, how do you go about checking the lab’s scope?
It’s hard to tell how extensive a lab’s scope can be, so it might be easier to email the lab’s sales department and ask if the ISO testing you’re looking for is within their scope. When reviewing a laboratory’s accreditation scope, remember to note the standard’s year or edition.
Another essential factor you should look for in selecting a third-party test laboratory is their area of expertise. Many labs have scopes that span many different product types and technologies.
In my experience, I have found working with a lab that specializes in medical device testing to be the most advantageous. They tend to have more specialized engineers/technicians familiar with many different medical devices from which you can benefit. Remember, using an accredited laboratory with the appropriate scope and expertise is one way to ensure you will receive accurate test results and the highest quality of service.
Many labs are designed to operate as Black Holes. You throw your product in there, magic happens, and a compliance or non-compliance report pops out. You DO NOT want to work with a lab like that.
Although testing is conducted against written standards, the application of specific tests to your product could be subject to interpretation. You want to partner with a lab that recognizes that and is willing to reach out to you to discuss your particular application.
For example, performing the laboratory accuracy test for a clinical thermometer with a dedicated temperature probe that is remote from the main body of the equipment is very straightforward. But how do you perform the test when the temperature probe is integral to the main body of the equipment, which is so tiny you cannot have part of the equipment in ambient conditions and another piece in the water bath?
The laboratory should:
Before engaging a third-party testing lab for your medical device, you need to ask how the lab handles non-conformities. Some labs may give you unclear or varied answers. Some may leave you clueless, withholding crucial information until the end.
You need to find a lab that utilizes a balanced approach and knows the difference between a minor and major non-conformity. You don’t want to be inundated with emails or phone calls from your lab every few minutes letting you know you’re missing specific texts from your IFU, as those are typically easy to update.
Throwing the book (standard) at you and simply reporting a non-conformity doesn’t cut it either. The lab should help you understand each non-conformity and provide possible mitigations. Remember, professional labs with years of experience testing medical devices can clearly explain the standard’s requirements and provide alternative routes to compliance.
Thirteen years in the testing and regulatory environment have molded me to acquire a deeper understanding of the medical device industry. It has also given me sufficient data and knowledge on how I can help businesses like yours thrive by getting your devices approved to market through systematic, robust, trustworthy, and proven testing methods.
Let me start by guiding you to the right path.
At Biotex, a premier medical device manufacturing company with over 25 years of experience in the industry, we tap into the expertise of Criterion, our in-house testing laboratory, to prepare our clients’ devices for successful commercialization. As the current Regulatory Affairs Manager of Biotex and Laboratory Manager of Criterion, I work with medical device companies like yours by delivering a thorough and cutting-edge process to test, evaluate, and re-evaluate medical devices for prompt regulatory approval and successful commercialization.
We can help you, too.
At Criterion, we guarantee:
Using our broader experience in the medical device industry, we at Criterion have an extensive understanding of the market, giving us leverage in providing better assessments and evaluations for those who seek our help, including you.
Because Biotex and Criterion have been in the medical device design, development, and manufacturing business for more than two decades, we can assure you that we have walked your path and worn your shoes. We also understand and can deeply relate to the blood, sweat, and tears you have poured into your product.
We want to be there with you at every step of your journey, from designing your product to seeing your medical device get approved for marketing, so it can thrive, save lives, and rock the world like never before.
That’s our standard in testing, and that’s the Criterion Way.
Visit us at Criterion to learn more.
