Are You Working With The Right Medical Device Package Testing Lab?

Finding a medical device package testing laboratory and being able to trust that lab is an overwhelming prospect. Without proper testing and validation, not only will your packaging fail, but it will also jeopardize the medical device within the package and your company’s reputation.

Here is a five tip checklist to make sure you are working with a medical device package testing laboratory that you can trust.

Tip #1
Is Your Lab ISO Registered?

Many labs are ISO compliant, but this is not the same as being ISO registered.

ISO Registration means that the medical device package testing lab is required to:

assure high quality testing processes
develop documentation for each phase of the testing process
partake in ongoing auditing
commit many years to achieving registration
apply for a certificate by a Notified Body with a registration ID number

Tip #2
Does Your Lab Make Accommodations for Your Unique Needs?

You are the client. You are the client.
If you are paying for a service, it is important that it meets your unique needs.

If you are feeling that your medical device package and product testing projects require unique needs and the testing lab you are working with is trying to force fit your project into a pre-defined testing mold, look for a lab that has experience deploying customized testing services.

Tip #3
Does Your Lab Do What It Says It Is Going to Do?

We all know that some labs will say anything to keep a customer happy, but the proof is in the action.

If you are told that you’ll receive a call back tomorrow, yet receive a call in 3 days — Take Heed.

If you are told that you will receive a proposal in 3 days, but receive it in 2 weeks — Beware.

If you are told that a test can begin in 1 week, but it doesn’t begin for 2 weeks — Well, at that point it’s probably too late...

Tip #4
Do You Have to Define Industry Terms?

If you have to direct the lab to www.astm.org or www.ista.org to learn more about D4169-04, DC 13, or ISTA 3A testing, consider contacting another lab.

Your laboratory should understand the medical device package testing industry inside and out. Furthermore, you should feel like your testing lab is educating you in industry terms and requirements, not the other way around.

Tip #5
Does Your Quote Match Line-for-Line the Specs of Your Request

Medical device package and product testing quotes should contain the following information:

A match — line-item for line-item — to your unique specifications
A clear description of the testing services to be performed
A clear indication of pricing and payment terms

In order to avoid translation errors, insist on sharing specifications directly with the package engineer who will be drafting your testing proposal.