One firm, answerable for every document in your file.

In short

What kind of firm this is

Probity Sciences is a packaging validation consultancy for medical device manufacturers, focused on ISO 11607 and working across the United States. We author the evidence, choose and manage the accredited laboratory that runs the testing, and stand behind the reasoning a reviewer reads. The laboratory runs the machines; we own the file and the reasoning behind it.

How the work is run

Every document is written in house, start to finish.

We write the validation plan, the test matrix and its rationale column, the sample size justification, the individual test protocols, the laboratory statement of work, the data review and the validation summary report. We qualify the laboratory, raise the sample submission instructions, track the chain of custody and read the results. Every one of those documents is written in house, and it stops following the template at the point where your device stops matching it.

The practice is based in Washington State, works nationally and delivers remotely. Your samples go to the laboratory that fits the method, the accreditation scope and the schedule, wherever that laboratory happens to be. On a deadline, what matters is chamber availability, not how far you are from us. Delivery is remote by design, which keeps travel off your schedule and off your invoice.

Email comes back the same business day, from a person rather than a queue, and whoever replies is doing the work rather than fielding it for someone else.

Capacity

When your program needs an answer, it does not wait in a queue.

A validation program takes forty-eight to eighty-four hours of our time across three to six months, so the constraint is not the hours but when they fall. Protocol drafting, a laboratory deviation and a data review that raises a question do not arrive on a schedule, and your program gets each one answered the day it lands. So concurrent validation programs are capped at the number we can drop everything for without the others moving, and we will tell you where that count stands on the call. Gap assessments run alongside, since one is ten business days from receipt of your documents and carries no laboratory schedule to hold open.

When the cap is reached we will give you the date we can start rather than take the work and let your pull points slip. If that date does not fit your submission, say so and we will tell you who else does this properly.

What you own

The deliverables are your property from the day they are written.

Not on final payment and not at project close. Every plan, protocol, justification, data review and report belongs to you as it is produced, in the file formats your quality system uses, written so a competent packaging engineer or your laboratory could execute it without speaking to us. You are the manufacturer. You approve the validation and you own it. Our name is never in your approval block.

If we are ever not available, your file does not stall. Everything is handed over as it is written, nothing is held back, nothing is locked in our heads or our systems, and the evidence package reads as a set of instructions anyone competent could follow rather than a record of our involvement.

For twenty-four months after delivery we remain available to help you answer questions from a regulator, notified body or certification body about our work. Four hours are included per validation program and one hour per gap assessment. Beyond that, support is chargeable at the rate in your statement of work. We keep a copy of the record set for seven years because our quality system requires it, which is an obligation on us and not a claim on your documents.

Independence

Nothing steers your laboratory choice but the method and the deadline.

Every dollar we earn on your program is visible on your invoice. Laboratory charges are passed through at cost with the laboratory's own charge shown against them, and the handling percentage is a disclosed line item, so you can see exactly what we earn on your samples. That stays true because the practice holds no stake in any laboratory, converter or packaging supplier, and takes no commission or referral fee for placing your work.

We are paid the same whether we find problems or not, and that is the point of asking us rather than someone who profits from the answer. A finding that your file already holds up and needs nothing is a real result and gets a real section in the report.

Qualifying a laboratory means reading its scope of accreditation for your method, not admiring its certificate. Its test method validation for your method is checked before your samples go anywhere.

Where the method comes from

The method came from test and evaluation, outside medical devices.

The method came from test and evaluation, in a national authority outside medical devices, where the evidence had to satisfy people whose job was to doubt it before anything was cleared for use. The consequence of a wrong answer there was not a delayed submission. What transfers is a way of working inside deep regulation without a certificate to hide behind: evidence assembled to survive somebody else's reading, and the reasoning written down at the time rather than reconstructed afterwards.

The transferable part is narrow, and it is worth naming exactly. The job was deciding what a claim has to prove, designing the trials that prove it, and defending the reasoning to someone paid to doubt it. That is what a packaging validation package is. The second half is custody: chain of custody run at national scale, where one broken link voids the evidence it was built to support, and sample traceability is where validations come apart.

The standards work, the template library and the quality system are already in place, and the gap assessment is deliberately small, so you can test the work at $2,500 and ten business days before committing to a program.

The boundary

Where this practice starts and stops.

Who runs the testing

Testing is performed by accredited laboratories we select and manage on your behalf. We own no test equipment and generate no test data, so what reaches your file is the laboratory's result and our reading of it.

Who holds the accreditation

The laboratories that run your tests hold ISO/IEC 17025 accreditation, within a scope we verify for each method. We hold none ourselves and claim none.

How the quality system stands

The quality system is written against the supplier control expectations of ISO 13485, and the quality manual is available on request. There is no ISO 9001 or ISO 13485 certificate here, and no registration that implies one.

Where the submission sits

We write the packaging evidence and hand it to whoever owns the submission. Making the submission, and the rest of the 510(k), stays with your regulatory team.

What we commit to

Scope, schedule, the sampling rationale in writing, and our help answering an FDA question about the packaging section, within the support hours in your statement of work. Nobody can guarantee a clearance, and anyone who offers to is telling you something useful about themselves.

Anyone who blurs those lines is worth a second look.

Qualifying us as a supplier

The file you need before you can raise the purchase order.

Your own quality system obliges you to evaluate and select the suppliers whose work affects your product against documented criteria, and to keep the record of that evaluation. Where that obligation is written down has moved: 21 CFR 820.50 named suppliers, contractors and consultants in those words until the Quality Management System Regulation took effect on 2 February 2026, and 21 CFR 820.7(b) and 820.10(a) now incorporate ISO 13485:2016 by reference instead. An older purchasing controls procedure may still cite either, and the pack answers either wording. That record is usually the slowest part of bringing on a new supplier, because the documents arrive one email at a time. So the four documents are kept in one place and sent on request: quality policy, Form W-9, mutual non-disclosure agreement and independence declaration.

Ask for it, file it, and come back when it clears your process. An email is all it takes; a call is for when you want one.

Also worth reading

How a program actually runs

The branch structure, the standards at each stage, and what lands in your hands at the end.

How we work, and how we correct errors

The quality system in plain language, including what happens when we get something wrong.

Packaging Standards Gap Assessment

$2,500 fixed, ten business days from receipt of your documents, no laboratory testing.

If the answers here hold up, book the call.

Thirty minutes, no slides. Bring the device description and the sterilization method, and we will talk through what a program for your device would involve, what it would cost and how long it would take. If the honest answer is that you can do this in house, you will get that instead.