Packaging validation for a 510(k): what it costs, how long it takes, and what you get.
A gap assessment tells you what your packaging file is missing, ten business days from receipt of your documents, $2,500 fixed. A validation program produces the whole package, from protocol to submission-ready report. Your professional fee is fixed at scoping, before you sign anything, and laboratory charges pass through at cost. Programs in this scope run $25,000 to $40,000 all in.
In short
What you are buying
A decision, written down, with the data underneath it. Which evidence your device actually needs, why those tests and those sample sizes, the results from an accredited laboratory, and a validation summary report that traces every line of it back to the clause it answers. A laboratory sells machine time: it will run whatever protocol you specify and it is not engaged to tell you the protocol is wrong. You approve every step. The rationale is the product.
Who this is for
- Class II terminally sterilized device manufacturers of roughly 20 to 300 people with no packaging engineer on staff.
- A 510(k) or other submission planned in the next twelve to eighteen months, or a packaging finding sitting open from an audit.
- Quality and regulatory engineers who inherited packaging along with design controls, risk management and supplier quality, and who will be the name on the declaration of conformity.
Dated notice
FDA recognition 14-530, the un-amended ISO 11607-1:2019, is not accepted for declarations of conformity in premarket submissions after 20 December 2026. Put against your own calendar: if your submission goes in after that date and you intend to declare conformity to ISO 11607-1, the declaration points at the edition including Amendment 1:2023, and a packaging file assembled before Amendment 1:2023 existed was not written to show the linkage to your risk file. This is a documentation gap rather than a testing gap, and it applies to premarket submissions only. Where the underlying test evidence still stands, closing it is documentary work rather than a re-run of physical testing. Ten business days tells you which side of it you are on.
What the 2026 transition actually requiresHow the money works
- Your professional fee is fixed at scoping
Fixed against a written scope, before you sign, and it holds. An hourly estimate is a number that moves after you have committed.
- Laboratory charges reach you at cost
You see the laboratory's own charge, shown against the pass-through line on your invoice, at the number the laboratory billed. The charge for managing the laboratory is our fee, on its own disclosed line, so the pass-through is something you can check rather than something we assert.
- Our fee is the only money we make on your job
No commission, rebate or referral payment reaches us from any laboratory or packaging supplier. If one is ever offered on a job, you are told. So the laboratory is selected on the method, the accreditation scope and the schedule, and on nothing else.
- You see the whole scope before you sign
What is covered, what is excluded, and what happens if a regulator has questions after you deliver. You read all three before you sign, not in a schedule handed to you later.
- If you hold an SBIR or STTR award, it may already cover this
Technical and Business Assistance funds sit on top of the award for outside specialist work, and since April 2026 you choose the provider and name them in your budget justification. The gap assessment fits a Phase I allowance and the full program fits a Phase II subcontract line.
Lead offer
01Packaging Standards Gap Assessment
A clause-by-clause read of your existing packaging documentation against ISO 11607-1, including Amendment 1:2023, and against ISO 11607-2, delivered as a graded findings report with a prioritized remediation plan.
- Fee
$2,500
Fixed at signature, and the same whichever way the finding goes.
- Duration
Ten business days
From receipt of your documents.
- What moves
Documents only
Nothing ships and nothing goes in an oven. We read the file you already hold.
- Contract
One page
A short form agreement rather than a master services agreement, so a $2,500 purchase does not have to wait on a legal review cycle.
One finding worth naming in advance
A possible finding is that you have no gap and need nothing. That is a real section of the report, written as plainly as the rest, and the fee is the same either way. That is the point of asking someone whose fee does not move with the answer.
The specialist on your call reads the file and writes the report, so you deal with the person doing the work and nothing is lost in a handoff. Your documents are read clause by clause against ISO 11607-1 including Amendment 1:2023, and against ISO 11607-2 for the sealing process side.
In scope
- One product family and one packaging system.
- Up to 15 documents or 200 pages, whichever comes first.
- Clause-by-clause conformity matrix against ISO 11607-1 including Amendment 1:2023, and against ISO 11607-2.
- Every finding graded as a documentation gap, an evidence gap or a testing gap, because the three cost very different amounts to close.
- Standards and editions table with the FDA recognition numbers that apply to your declaration.
- Your ISO 11607-1 declaration of conformity position, and what changes for submissions made after 20 December 2026.
- Risk management linkage: which packaging decisions your ISO 14971 file already supports and which are unsupported.
- Prioritized remediation plan with effort estimates, and a section on what is fine and needs nothing.
Out of scope
- Laboratory testing and protocol execution belong to the validation program. This is a read of the file you already hold.
- You are the manufacturer, so you file. Your name is the only one in the approval block.
- Sterilization process validation, biocompatibility and device design sit outside this review, except where they constrain the packaging.
- Additional product families are $1,200 each. Beyond the page limit we quote before proceeding.
You get the clause-by-clause read, the grading and the written remediation plan, on the documents you provide. Whether a regulatory authority accepts a submission is that authority's decision, and nobody can promise it.
TEMPLATE
Conformity matrix, one row of the blank template
This is our own blank template. The clause text is paraphrased rather than quoted, and the grading column is our reading, labeled as ours rather than written as a requirement. The rows are populated from your files during the ten days.
| Clause | Clause text, paraphrased | Evidence expected on file | How it grades |
|---|---|---|---|
| ClauseASTM F1980-21 section 1.5 | Clause text, paraphrasedDistribution, handling and shipping events sit outside the scope of the accelerated aging guide. | Evidence expected on fileA dated decision recording which arms were run, whether any were combined, and the risk basis for the choice. | How it gradesOur reading, and labeled as ours: a combined transit and aging arm with no recorded reason is an evidence gap, because a defect found afterwards cannot be told apart from a time-related one. We grade the missing reasoning, not the choice. |
Core offer
02ISO 11607 validation program
We run the whole thing: plan, test matrix and rationale, sample size justification, protocols, laboratory selection and management, data review, and a submission-ready validation summary report with clause traceability.
What it costs, and what moves the number
Professional fees are fixed at scoping. Laboratory charges are passed through at cost with the laboratory's own charge shown against them, and the charge for managing them is a separate disclosed line.
A program in this scope is priced at $25,000 to $40,000 all-in, including laboratory charges at cost.
The spread is driven by how many packaging configurations you have, your sterilization method, and whether the sealing process is already validated. Your number is fixed at scoping, before you sign anything.
50 percent of professional fees and 100 percent of estimated laboratory charges on signature, balance on delivery. Laboratory funds are held separately and paid to the laboratory.
Three to six months, assuming an accelerated arm of roughly one to three months. A longer shelf life claim, or a lower chamber temperature, puts a program outside that range. Aging duration is set by physics, so the schedule is built backwards from your submission date on the first call and you know on day one whether the date holds.
What you are paying us to decide
ASTM F1980 section 1.5 puts distribution, handling and shipping events outside the scope of the aging guide, so aging evidence and distribution evidence answer different questions about the same package. No order between them is mandated. The judgment being bought is which arms your device's risk profile justifies, whether combining them is appropriate or whether combining them would destroy your ability to tell an event-related defect from a time-related one, and the written reasoning for the choice. Amendment 1:2023 applies a defined risk management process to packaging. A documented, risk-based choice of arms is exactly what it asks for.
The program drawn as a branch, not a chainWhat you receive
Eleven documents, into your quality system under your document numbers, and you own every one. The last of them ties every claim back to the evidence that supports it in one connected read, and that is the reason to use us rather than call the laboratory directly.
- Discovery and intake record.
- Packaging validation plan.
- Test matrix with a rationale column. The rationale column is the whole game.
- Sample size justification, written to be defended in an Additional Information response rather than to fill a field.
- Sample build and chain of custody records. A result is only as defensible as the record of which samples produced it.
- Individual test protocols: ASTM F88, ASTM F1929, ASTM F2096, ASTM F1980, ASTM D4169 or ISTA 3A, as the matrix justifies.
- Laboratory statement of work, so what you are buying from the laboratory is written down before samples ship.
- Deviation and nonconformance handling.
- Test data review against the acceptance criteria set before the data existed.
- Validation summary report with clause traceability, so a reviewer can follow every claim back to the evidence that supports it.
- Change control and revalidation guidance, so the next material change does not restart everything.
Ownership and control
- You are the manufacturer. You approve and own the validation.
- Deliverables and protocols are your property from day one, whatever happens to the relationship.
- Your name is the only one in the approval block.
- A failing result is a valid outcome of a correctly specified test. It is recorded, investigated and handled as a deviation, on the same file as everything else.
You get the scope, the schedule and the reasoning in writing. No validation program, ours or anyone else's, guarantees that a regulatory authority will accept a submission.
Book a 30-minute callProgram structure, scoping and what is fixed whenAlso available
03Amazon SIPP and ISTA protocols
Distribution testing and the paperwork for Amazon's packaging program, run under a one-page short form agreement.
Quoted per job, on the same terms as everything else: laboratory charges at cost, a fixed professional fee. Part of the program is self-certifiable, and where it is, we will tell you rather than quote you.
Ask about a SIPP jobAfter delivery
If a regulator asks questions later, we are still on the file
For 24 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, one hour for gap assessments. Beyond that, support is chargeable at the rate in your SOW.
You have these hours in writing before the work starts, not offered as a favor on the day you need them. The alternative is finding out what an Additional Information response costs at the moment you need one answered, and that is the position you are paying to avoid.
Independence
No one pays us to choose your laboratory or recommend your materials
- Your samples go to the laboratory whose accreditation covers your method
Testing runs at laboratories holding ISO/IEC 17025 accreditation, and we check that the scope of that accreditation covers the specific method your device needs, because accreditation is method-specific rather than general. We are tied to none of them, so the choice is made on merit: on a deadline, chamber availability decides more than travel does.
- The laboratory's own charge is what reaches your invoice
It is shown against the pass-through line at the number the laboratory billed, and the charge for managing the laboratory is our fee on its own disclosed line. No commission, rebate or referral payment reaches us from any laboratory or packaging supplier, and if one is ever offered on a job, you are told.
- A recommendation about your materials is only ever about your evidence
We have no packaging to sell you, no packaging supplier relationships and no affiliate arrangements, so the only thing a material or seal recommendation can be built on is what your file has to prove.
- We write the packaging section. You file it under your name
We write the packaging validation section and the evidence behind it. You review it, you approve it, and it goes in under your name. If you have a regulatory consultant, we work to their submission schedule and stay out of their relationship with you.
The supplier qualification pack is sent on request, and our quality manual is available the same way. Between them they answer the certification and accreditation questions a supplier file asks, including where our quality system sits against ISO 13485.
Supplier qualification pack
Supplier qualification packQuestions
The questions you would put to us on a call, answered straight
- Are you a laboratory, and are you accredited?
No to both, deliberately. We design the program, justify the sample sizes, select and qualify the accredited laboratory against its actual scope, manage the study and write the evidence. A laboratory that also told you which tests to buy would be marking its own homework. ISO/IEC 17025 accreditation applies to the entity generating the test data, so it sits with the laboratory that runs your methods, and the scope of that accreditation is something we check against your specific method. Anyone who blurs that line is worth a second look.
- Why not go straight to the laboratory?
If you already know which tests you need and you can defend the sample sizes in writing, go direct and save our fee. The laboratory will run exactly what you ask for. It is not engaged to tell you that what you asked for is wrong, and it has no commercial reason to volunteer it.
- Is ISO 11607 even mandatory for us?
Conformity to a recognized consensus standard is voluntary. ISO 11607 covers packaging for terminally sterilized medical devices, so a device that is not supplied sterile, or that is aseptically processed rather than terminally sterilized, may sit outside its scope entirely. Declaring conformity is the usual route into a submission, not the only one. When the honest answer is that you need nothing, we say so, and you have still bought the answer rather than a program.
- Who writes the packaging section of a 510(k)?
Where a manufacturer of this size has no packaging specialist, it lands on whoever owns design controls. We write the packaging validation section and the evidence behind it. You review and approve it, and it goes into your submission under your name.
- Can you review a protocol we have already written?
Yes. That is the gap assessment, at the same fixed $2,500, and a protocol plus its rationale is well inside the document limit. If the protocol holds, you get that in writing, and there is less remediation to pay for in whatever follows.
- Can we do this in house?
Some firms can, and here is the honest test. If you have a written sampling rationale you would defend in an Additional Information response, a documented reason for the test structure you chose, and a test method validation position for every method, do it in house. If you cannot answer all three, those are the three gaps to close before you submit.
- How many samples will we need?
Not a number we will guess at on a web page, and be suspicious of anyone who does. Sample size follows from the risk, the data type and the confidence and reliability you are claiming, and the rationale is the deliverable rather than the number.
- Do you validate our sealing process?
ISO 11607-2 sealing process validation covers your manufacturing process, running on your equipment or your contract manufacturer's. We write and manage the protocol, specify the studies and assemble the evidence, and the sealer stays on your floor and in your hands. Part 1 and Part 2 are different jobs and confusing them is the tell.
- What if a test fails?
A failing result is a valid outcome of a correctly specified test. It is recorded, investigated and handled as a deviation. A validation program that cannot produce a failure was not testing anything.
- Can you do it faster?
The paperwork, yes. The aging, no. Q10 arithmetic sets the oven time: a three-year claim is 1095 days, and at 60 C against a 23 C ambient with a Q10 of 2.0 the acceleration factor is 12.996, so the accelerated duration is 84.26 days. We schedule 85, because rounding down would age the samples for less time than the claim they support. A real-time lane keeps running underneath regardless. A five business day gap assessment is available at plus 50 percent, because that one is document work.
- Can you guarantee we get cleared?
No, and nobody can. What is committed is the scope, the schedule, the sampling rationale in writing, and the regulatory-response hours written into the engagement above. A consultancy that promises the outcome instead is the documented red flag in this market.
- Who owns the validation?
You do. You are the manufacturer, the deliverables and protocols are your property from day one, and your name is the only one in the approval block.
- What do we judge the packaging competence on?
The clause-level work on this site and the first thirty minutes on a call. Both are on this page already: the aging arithmetic carried to 84.26 days and then scheduled at 85 with the reason written next to it, and the conformity matrix published blank, as our own template. Bring your own file to the call and the same reasoning gets applied to it in front of you. The background is set out in plain terms on the About page.
- What does the 20 December 2026 date actually change for us?
If you submit after that date and you intend to declare conformity to ISO 11607-1, the declaration points at the edition including Amendment 1:2023, which applies a defined risk management process to packaging. A packaging package written before Amendment 1:2023 existed was not written to show that linkage to the risk file. It is a documentation gap rather than a testing gap, it concerns premarket submissions, and it does not touch devices already on the market.
Fit
When this is the wrong purchase
- You have a packaging engineer who already writes and defends the sampling rationale. Buy the laboratory time directly and keep our fee.
- Your products are cleared and nothing is going in. The 20 December 2026 date reaches premarket submissions, so it does not change what is already on the market.
- You want a number without a rationale. The number is the cheap part, and it is the rationale that an Additional Information response asks for.
If the call ends with you needing nothing from us, you still leave with the answer you came for, and that is worth the thirty minutes on its own.
Thirty minutes, your device, no slides.
Bring the device description, the sterilization method and your target submission date. You leave the call with a straight read on the evidence your submission needs, which of these two services fits, and what it would cost.
A personal reply the same business day, from the person who would do the work, not a queue.
Book a 30-minute callSee how a program runs