Find out what your packaging file is missing, in ten business days, for $2,500.

In short

What an ISO 11607 gap analysis reads, and what it costs

An ISO 11607 gap analysis reads your existing packaging documentation against ISO 11607-1 and ISO 11607-2, including Amendment 1:2023, and grades every finding as a documentation gap, an evidence gap or a testing gap. Ours is $2,500 fixed, ten business days from receipt of documents, and is done entirely from documents you already hold. A possible finding is that you have no gap and need nothing.

The deliverable

What arrives on day ten, section by section.

You can read the nine section titles now, so nothing in the report arrives as a surprise on day ten. Every finding carries the clause it came from, so it files straight into your design history file and goes to an auditor without a rewrite.

1Scope and limitations

What was assessed, which documents were provided, what was not assessed, and the limits of what a documents review can establish. Stated first rather than in a footnote.

2Findings summary, one page

Every finding, its grade and its clause, on a single page that can be forwarded to whoever signs. If your director reads one page, this is the page.

3Clause-by-clause conformity matrix

A row per applicable clause of ISO 11607-1 and ISO 11607-2, including Amendment 1:2023, with the document and section in your file that satisfies it, or a blank where nothing does. The blanks are the point.

4Findings, each graded

Every finding is graded a documentation gap, an evidence gap or a testing gap. The grade tells you what it costs to close before you read a word of the remediation plan.

5Standards and editions table

The standards your file relies on, the edition each citation points at, and the FDA recognition number for that edition where the standard is recognized. A citation pointing at a superseded edition is cheap to correct now and awkward to explain later.

6Declaration of conformity position

What your declaration currently claims, and what changes for premarket submissions made after 20 December 2026. This section reads your Part 1 position. Part 2 is scoped into a validation program rather than into a ten-day reading, and the recognition entries behind both dates are published on our methodology page with the date they were read.

7Risk management linkage

How your packaging evidence connects to the ISO 14971 file, clause by clause, and where the connection is asserted rather than shown. This is what Amendment 1:2023 actually asks for.

8Prioritized remediation plan

What to fix, in what order, with an effort estimate against each item so you can plan it internally or price it out. Items you can close yourself are marked as such.

9What is fine and needs nothing

A real section, not a courtesy. Work that already holds is listed with the clause it satisfies, so you can stop worrying about it and stop paying anyone to look at it again.

Who does the reading

The specialist who reads your file is the one who signs the report.

Performed by the specialist, reviewed against ISO 11607-1 AMD1:2023 clause by clause.

The specialist who takes your call sends the document request and writes the report, so the person who hears the problem is the one who answers it, and your file stays with them from the first call to the final page. Before you send anything, you can check exactly who that is: the supplier qualification pack is yours on request.

How findings are graded

Three grades, because they cost three different amounts to close.

Documentation gap

The work was done and the record does not show it. Closing it is writing, not testing, which makes it the cheapest of the three grades to close.

Evidence gap

The record exists but does not support the claim being made from it: pull points that do not reach the shelf life claimed, or acceptance criteria that appear in the record after the results. Closing it sometimes means writing and sometimes means testing.

Testing gap

Something has to be run. The report names the method, says why it is needed and what it establishes, so you can take it to a laboratory yourself or ask us to quote the program that arranges it.

The honest finding

A possible finding is that you have no gap and need nothing.

If that is the finding, the report says so and shows the working: the clause list, what satisfies each one, and where in your file it lives. The fee is the same either way, because you are paying for a reading rather than for a list of problems. "You are fine" is the most dangerous sentence in this business, and it is written here only with the clause by clause evidence sitting behind it.

Scope

What the reading covers, and where it stops.

In scope

Clause-by-clause conformity review

Your packaging documentation read against ISO 11607-1 and ISO 11607-2, including Amendment 1:2023, clause by clause, with the clause number recorded beside every finding.

The risk management linkage

Whether your packaging decisions connect to your ISO 14971 file in a way a reviewer can follow. This is the substance of Amendment 1:2023. Our reading, labeled as ours: a packaging file assembled before 2024 had no particular reason to show that linkage, because the edition it was written against did not ask for it.

Sample size and acceptance criteria rationale

Whether the basis for your sample sizes and acceptance criteria is written down, and whether it would survive being asked about. Not whether we would have picked the same numbers.

Standards and editions

Every standard your file cites, checked against the edition FDA recognizes, with the recognition number recorded where one exists and its absence recorded where it does not.

Declaration of conformity position

What your declaration of conformity currently points at, and what that means for a premarket submission made after 20 December 2026. That date is verified at source, for both parts, from recognition entries 14-530, 14-594, 14-531 and 14-595, read on 4 August 2026.

Test method validation position

Whether every test method used to show conformity has a documented validation position, and whose position it is. A method validated by the laboratory that runs it is a different record from a method nobody has validated at all.

Sealing process validation records

Whether the Part 2 process side exists in the file at all. Part 2 covers the forming and sealing process, and a file can be complete on the sterile barrier system and silent on the process that makes it.

A prioritized plan

What to fix, in what order, with an estimate of the effort each item takes. Ordered by what is likely to be questioned and by what each item costs to close.

Out of scope

Laboratory testing

The assessment is a reading of documents. Where a finding can only be closed by running something, the report names the method, says what it would establish, and stops there, so you can price it yourself or ask us to quote the program that arranges it.

Writing your protocols

The assessment tells you what is missing. Writing the packaging validation plan, the protocols and the summary report is the full program, quoted separately.

Your submission

You make the submission. You are the manufacturer, you approve and own the validation, and yours is the only name in the approval block.

Devices and packaging systems beyond the agreed scope

One product family and one packaging system are covered. Additional families are $1,200 each and are agreed before we start, not invoiced afterwards.

What happens on the floor

The findings are based on the documents you send. Where a finding turns on whether the documented process is the process performed, the report says so and tells you what to go and check.

How it runs

From documents received to report in ten business days.

01A 30-minute call

Your device, your class, your sterilization method, your packaging system and your submission date. Thirty minutes is enough to establish whether this assessment is the right thing to buy, and we will say so if it is not.

02Mutual NDA, then the short form

The NDA is in place before you send us anything. The engagement is one page and the scope on it matches the scope on this page.

03The document request

A written list, sent the same business day. You send what you have. Missing documents are a finding, not a problem. If you already know something is absent, that is a reason to have the file read, not a reason to hold it back.

04Ten business days

The clock starts when the documents arrive, not when the contract is signed. If your file is larger than the limit, we tell you before we start and quote the difference, so the invoice matches the number you agreed.

05The report

Delivered as a document you own outright, in a format you can file in your design history file and hand to an auditor without rewriting it.

What we need from you

The document request, published in advance.

You can see now whether you have these. Anything you cannot find is itself an answer, and the list is worth gathering before the call either way.

• Any existing packaging validation plan, protocols or reports
• Drawings and specifications for the sterile barrier system, including material and supplier
• Sterilization method, cycle parameters and the maximum number of cycles the packaging sees
• Sealing process parameters and any sealing process validation records
• The shelf life claim and any real time or accelerated aging data behind it
• The distribution profile the packaging is expected to survive
• The packaging entries in your risk management file
• Test reports from any laboratory work already completed, including the methods used
• The packaging section of any prior submission, and any audit or review findings on packaging
• The change history for the packaging system since it was last validated

Work already underway

Already have a protocol, or a lab quote you are not sure about?

Send it. You get it read against ISO 11607-1 and -2, including Amendment 1:2023, with what a reviewer is likely to question written down and the clause behind each point. We are independent of every laboratory and the fee is fixed, so a finding that the protocol is sound and the quote is reasonable costs exactly what any other finding costs.

The dated fact

What changes on 20 December 2026, stated narrowly.

FDA recognition 14-530 covers ISO 11607-1:2019 without Amendment 1. Declarations of conformity to 14-530 are accepted in premarket submissions until 20 December 2026; recognition 14-594 covers the amended edition. This is a documentation gap rather than a testing gap, it applies to premarket submissions only, and it does not mean a device already on the market has to be revalidated. Whether it reaches your file depends on whether you have a submission planned and whether your packaging has changed, and thirty minutes on a call settles both.

After delivery

What you own on day ten, and what we owe you for two years after.

Deliverables are your property from day one. You are the manufacturer, you approve and own the validation, and yours is the only name in the approval block.

For 24 months after delivery, if a regulator, notified body or certification body asks a question about our work, the person who wrote the report helps you answer it. One hour is included with a gap assessment; beyond that, support is chargeable at the rate in your engagement.

Questions in that period go straight to the person who did the reading.

What a documents review establishes

What this reading settles, and what it cannot.

You come away knowing what your file says, whether it holds against the clauses it answers to, and what each gap costs to close. The reading is built from the documents you provide, so where a finding turns on what happens on the production floor, the report says so and tells you what to check. No reading of a file can commit a regulator to anything. What is committed is the scope, the ten business days, the reasoning in writing with the clause behind every finding, and a named person who remains available to explain it.

Before you book

Questions worth asking before you buy this.

What is included in an ISO 11607 gap analysis?

A clause-by-clause conformity matrix against ISO 11607-1 and -2 including Amendment 1:2023, every finding graded as a documentation, evidence or testing gap, a standards and editions table with FDA recognition numbers, your declaration of conformity position, the linkage to your ISO 14971 file, a prioritized remediation plan with effort estimates, and a section on what is fine and needs nothing.

Can you review a packaging validation protocol we have already written?

Yes. It is one of the clearest cases for buying this, because a protocol is cheaper to correct before the samples ship than after the results are in. The protocol is read against the same clauses as everything else, and the findings record what a reviewer is likely to question about it, with the clause each point comes from.

Do you run any tests as part of this?

This is documents work from end to end, which is what holds it at $2,500 and ten days. If a finding can only be closed by running something, the report names the method and what it would establish, and you can take that to a laboratory yourself or ask us to quote the full program, where accredited testing is arranged and managed for you.

Who does the work?

The specialist who takes your call reads the file, writes the report and signs it, start to finish. Your file stays with the person who heard the problem from the first call to the final page.

Is the fee credited against a full program?

The $2,500 stands on its own: it is the same whether the report finds nine gaps or none, which is what keeps the reading independent of any sale that might follow it. It is not credited against later work, and that term is written on the one-page engagement you see before you sign.

Can you guarantee our submission clears?

No, and anybody who says otherwise is telling you something they cannot know. What we commit to is the scope, the ten business days, the reasoning in writing, and being available to explain it if a regulator asks.

What if you find nothing?

Then the report says so, section by section, with the clause list behind it. The fee is the same. That outcome is worth buying too: it is the difference between believing your file holds and being able to show it.

Next

Thirty minutes, your device, and a straight answer.

Bring the device description and the sterilization method. You will leave the call knowing whether this assessment is the right purchase, what it would cover for your product family, and what to do instead if it is not.

Or email directly. A personal reply the same business day.

Related

Packaging validation readiness questionnaire

Fifteen questions you score in your own browser, free, before you buy anything.

Full ISO 11607 validation program

When the finding is that testing has to be run and written up.

How a program runs

The branch structure, the standards at each stage, and the elapsed time.

The 2026 transition

14-530, 14-594 and what a declaration of conformity has to point at.

Sample size justification

The reasoning a reviewer is likely to be looking for, worked through in public.

All services

The three engagements and how they price.