Probity Sciences
Book a 30-minute call

Contact

Tell us about the device.

Three ways in. Ask for a thirty-minute call, answer nine questions about your device, or write to the address further down this page. All three reach the same specialist, and any of them can end there.

A reply the same business day, from the specialist who would run the work, not a queue.

Fast lane

Book a 30-minute call

Thirty minutes, by video or by phone, with the specialist who would run the work. Bring the device description, the sterilization method and the packaging drawings if you have them. Early works just as well: a sketch and a target date are enough to have the conversation.

  • A working conversation about your device and your submission date. Bring the awkward question first: it is the one worth the thirty minutes.
  • We go through how a packaging evidence package is put together, which decisions drive its shape, and what would have to be settled before anything ships to a laboratory.
  • You get a straight answer on whether ISO 11607 reaches your device and whether the evidence you already hold covers it, free, including when the answer is that you are already there.

Afterwards you get a one-page outline of what a program for your device would involve, what it would cost and how long it would take. That is a scope and fee outline, not a test plan, and it is yours to circulate internally whatever you decide.

Booking

Booking is by email until the calendar is connected

Pick-your-own-slot booking goes live when the calendar is connected. Until then, write to us and you get two or three times to choose from, the same business day. It is the same specialist and the same call either way.

Email to book a time

Careful lane

Nine questions about your device

Six technical, three about you, and the last of those is optional. They are the questions a program has to start from, so answering them is already the first part of the work. The form stands on its own, and whether a call follows is yours to decide afterwards.

Step 1 of 2

The device

Approximate answers are fine, and four of these six carry an honest way to say you have not decided yet. Uncertainty here is information: it is the first thing a program has to work with.

One line is enough. A program starts from the device, not from a template.

Class II sterile devices are what this practice is built around. The class changes how much evidence a reviewer expects to see, not the way the program runs.

The single most load-bearing answer on this form. It sets materials compatibility and how many cycles the sterile barrier system has to survive. If the product sees more than one cycle, say so in the notes box at the end of step 2.

The format decides which methods are in scope: seal strength by ASTM F88, seal leak detection by dye penetration per ASTM F1929 where the package is porous, whole package gross leak detection by internal pressurization per ASTM F2096. Designations are bare here and carry their edition and FDA recognition number in the report. "Not decided yet" is a legitimate answer, and early is a good place to be standing.

The sealing process at your site or your contract manufacturer's: installation, operational and performance qualification under ISO 11607-2. That is a different question from test method validation, which is whether the laboratory's method has been shown to work on a package like yours. We check that against the laboratory's scope of accreditation before samples ship. "Not sure" is the most useful answer you can give us.

The month is enough, and it decides two things. If you submit after 20 December 2026 and intend to declare conformity to ISO 11607-1, the declaration has to point at the edition including Amendment 1:2023. That is a documentation question about a new submission, not a reason to revalidate a device already on the market. The date also has to clear a floor set by arithmetic: accelerated aging to a three year claim is eighty-five days at 60 degrees Celsius against a 23 degree ambient with a Q10 of 2.0. Paperwork can be compressed. That cannot.

What happens to what you type

  • Device details are held in confidence. A mutual non-disclosure agreement is in the supplier qualification pack, and it is signed before any documents change hands.
  • Your answers stay in the systems this practice runs on, and they are used to answer you and for that alone, unless you tick the box above the send button and ask for the occasional email it describes. They are never sold. The specialist who would run the work is the only person who reads them. They reach a laboratory once you have engaged us and agreed which laboratory, and no automated email sequence follows: any reply you get is written by a person.
  • Everything else on this site is free to read with nothing asked in return. Here the nine questions are the whole of what is asked: the checkbox under them is yours to leave alone, and the answers reach us either way.
  • Your phone number stays yours. The form has no field for it, and the one route in is you offering it when you book a call you would rather take by phone.

Or just email us

Writing directly works as well as any form. The address below reaches the specialist who would run your program: one person, one inbox. A question with a short answer gets a short answer, and that can be the end of it.

When to go straight to the laboratory

If you already know which tests you need, at what sample size, with a written rationale you would defend in an Additional Information response, book the laboratory directly. That is cheaper and it is the right answer. What we sell is the reasoning, and there is no sense buying reasoning you already have.

If you have to qualify us before we talk

Your own quality system obliges you to evaluate and document the suppliers whose work affects your product, and a packaging consultant is one of them. A purchasing controls procedure may cite 21 CFR 820.50, which names suppliers, contractors and consultants in those words, or ISO 13485:2016 clause 7.4.1. Both ask for the same thing, and the pack answers either wording: quality policy, Form W-9, mutual non-disclosure agreement and independence declaration, four documents sent on request.

Supplier qualification pack

Where the work happens

The practice is in Washington State. The work is national and delivered remotely: a gap assessment for a firm in Minneapolis would be the same job at the same price as one an hour up the road. Samples would go to the accredited laboratory that fits the method, the scope of that accreditation and your schedule, rather than the one nearest to either of us.