ISO 10993 readiness check
$3,650
A signed gap report on one device's biological evaluation plan and toxicological risk assessment against ISO 10993-17:2023 and 10993-1:2025. Yours to keep, and credited to a SafetyStack plan started within 45 days.
Groenakker SafetyStack
Hand off your device’s full design quality suite. One team. One fixed monthly price.
Six subject matter experts work to provide you with a safe and fully documented device, through design controls and the safety sciences. The price is fixed in writing before anything is billed.
Get your written plan
Free: a 30-minute call, then your plan in 2 business days.
Six areas. One team. One plan.
Device safety is not one job. It takes design controls and the safety sciences: six areas, each with its own subject matter expert, and each depending on the others. SafetyStack puts all six under one team and one schedule. Open an area to see what we deliver.
Design controlsSafety built into the device and its files
We deliver
- Design controls and the design history file
- Design verification and validation
- Process validation
- QMS and supplier quality
We deliver
- The ISO 14971 risk management plan and file
- FMEAs
- The benefit-risk analysis
Safety sciencesThe evidence that the device is safe
We deliver
- Sterilization validation
- Cleaning validation
- Reprocessing validation
We deliver
- Packaging engineering and validation
- Shelf-life studies
In a standard 18-month program
Full work in months 10 to 18
We deliver
- The ISO 10993-1 biological evaluation plan
- The test strategy
- Laboratory management
- The biological evaluation report
In a standard 18-month program
Planning input in months 2 to 8, then full work in months 13 to 18
About this serviceWe deliver
- Chemistry: extractables and leachables
- The toxicological risk assessment
In a standard 18-month program
Planning input in months 2 to 8, then full work in months 13 to 18
About this service
What you hand off
- The work
- Our subject matter experts write every plan, protocol, assessment and report.
- The running of it
- We choose, book and manage the laboratories, and we keep the schedule.
- The signature
- A named senior specialist signs what we deliver. You approve every record.
- ISO 13485:2016 certified
- ISO/IEC 17025 accredited, GLP certified laboratories
- Toxicological risk assessments reviewed by a board-certified toxicologist (DABT)
Choose how much you hand off
Pick the line that sounds like you. You will see what we do and what it costs.
Full Stack
We own your device's safety, from the first design input to evidence that is ready to submit.
A standard example: about $24,200 to $26,700 a month for about 18 months.
- All six areas, planned as one program around your design milestones
- Every plan, protocol, assessment and report written and signed
- The laboratories chosen, booked and managed
- A named senior specialist and a portal that shows who is doing what, and when
Who works when, on a standard Class II device
Quality engineering and risk management build the design and risk files. Biocompatibility and toxicology give planning input early, while the design can still change.
- At full work
- Quality engineering and risk management
- Planning input
- Biocompatibility and toxicology
- Not in these months
- Cleaning and sterilization; packaging and shelf life
Custom Stack
You run the program. We own the areas you choose, for the months you need them.
Or start from an example
Keep Current
Your device is on the market. We keep its files current as standards and the product change.
- Assesses each change to the product, its materials, suppliers and processes, in writing within 5 business days
- Updates the files when a standard is revised
- Tells you what changed and what, if anything, you need to do
Light upkeep: $950 a month. Files already current and changing little? Small updates only, for the whole product, on a 12-month agreement.
Single items
One document, one test or one defined job at a fixed price. You run the program.
Defined jobs at one fixed price
Find out where you stand4 jobs, from $1,050
Scoping and gap assessment
$5,500
A gap report on your quality system and design history file, with a 12-month plan.
Portfolio triage
$1,050per product family
Every legacy product family ranked by risk, revenue and deadline. Also used for acquisition due diligence.
Independent mock audit
$3,800
A 2-day FDA inspection or ISO 13485 audit by an auditor independent of your delivery team. Remote; on-site adds travel at cost.
Build one thing4 jobs, from $13,950
Sterilization validation program
$25,000
Strategy, protocol, sterilizer coordination and the final report.
About this serviceProcess validation package
$16,000per process
IQ/OQ/PQ protocols and reports for one process.
About this serviceFamily remediation
$13,950per product family
Gap assessment and updates to the evaluation plan, chemistry and laboratory plan, toxicological risk assessment and evaluation report of one legacy family. Complex families $20,950.
New Clinical Evaluation Report
$30,000
Clinical evaluation plan, report and literature search for one product line.
About this serviceFile, change or respond6 jobs, from $9,500
Submission evidence package
$10,000
Biocompatibility, toxicology and sterilization summaries and test tables, ready for your regulatory lead to file.
EU MDR biological safety package
$19,950
The biocompatibility and toxicology content of your technical documentation, constituent research included.
EU MDR technical documentation
$46,750Class IIa
The full Annex II/III technical file for one product line. Class IIb and III $90,000.
About this serviceChange Impact Pack
$9,500
In 2 to 3 weeks: the biocompatibility, toxicology and sterilization impact of a material, supplier or process change, with a test plan or a written rationale.
Deficiency Response Pack
$12,500per letter
An FDA additional-information letter or a Notified Body finding on biocompatibility or toxicology: we start within 72 hours, set the strategy and write the response.
A specialist, full-time
$25,950per month
One named specialist working only on your product, with senior sign-off and project management. Starts in 5 business days. Month to month.
One fixed monthly price. At typical rates, the lower one too.
The same six areas over the same 18 months, done four ways. SafetyStack is the only one with a price fixed in writing. At typical rates the others come to about $3,900 to $11,400 more a month, and hourly consultants cost more at any rate above $232 an hour. The published range is $200 to $400.
| How the work gets done | A month, on average | Against SafetyStack | What you take on |
|---|---|---|---|
| Groenakker SafetyStackOne team for all six areas | About $26,700a month, averaged over the 18 months | The only fixed priceAgreed in writing before the work starts. The other three are estimates. |
|
| Three other ways to cover the same work. None has a fixed price, and at typical rates each costs more. | |||
| One hire plus consultantsA full-time quality engineer for quality engineering and risk management, and hourly consultants for the other four areas | About $24,900 to $36,400a month, averaged over the 18 months | About $3,900 more a monthAt $300 an hour, the middle of the published range. It costs more than SafetyStack at any rate above $232 an hour. |
|
| Hourly consultants for everythingA consultant for each area, one day a week while it is worked | About $25,400 to $50,800a month, averaged over the 18 months | About $11,400 more a monthAt $300 an hour, the middle of the published range. It costs more than SafetyStack at any rate above $211 an hour. |
|
| Three full-time hiresA quality engineer, a sterilization engineer who also covers packaging, and a toxicologist | About $37,200a month, averaged over the 18 months | About $10,400 more a monthAt average salaries, with benefits. |
|
A ceiling, in writing
Hourly work has no upper limit. A plan has a fixed monthly price for a fixed number of months, agreed before anything is billed.
No idle months
A toxicologist on salary is paid for 18 months to do about six months of work. A plan charges for each area only in the months it is worked.
It ends when the work ends
No recruiting, no onboarding, and no payroll after the program. Keeping the files current afterwards is your choice.
When another way is the better choice: a hire suits steady, full-time work in one area for years, and consultants near $200 an hour can come in lower if you find and manage them yourself. SafetyStack is built for the usual case, where you need six kinds of subject matter expert for parts of a program and one monthly price you can plan around.
How these figures are worked out, with sources
- Hires: average US base salaries for an experienced medical device quality engineer ($111,872), a sterilization engineer ($110,352) and a toxicologist ($90,222), plus benefits at the US private-industry average, where benefits are 30% of pay costs. Recruiting, equipment, software and your management time are not included.
- Consultants: $200 to $400 an hour, the published range for mid-level regulatory consultants, for one day a week on each area in the months it is worked. Senior consultants are quoted at $400 to $600.
- Every row, SafetyStack included, covers the timeline drawn above, with biocompatibility and toxicology at work for six months. "About ... more a month" sets each alternative at $300 an hour, the middle of the published range, or at average salaries. Laboratory testing is extra on every row.
- Each monthly figure is that way's cost over the same 18 months, divided by 18. The 18 months are a standard example: your own plan sets the months and the areas, so the whole cost of a program differs from project to project.
Sources: Payscale, experienced quality engineer, medical devices (data of April 2025); Salary.com, sterilization engineer III (November 2026); Salary.com, toxicologist (November 2026); US Bureau of Labor Statistics, Employer Costs for Employee Compensation (June 2026); NIH SEED, Regulatory and Manufacturing Consulting for Life Sciences.
How it starts
Three steps, and the first two cost nothing.
Book the call
Pick a time for a 30-minute call with a scientist and tell us about the device. Nothing to prepare.
Get your written plan
Within 2 business days: the areas, the dates, the documents we will deliver and one fixed price. The plan is free.
Approve it, and we start
Billing starts only when you approve the plan. Your named senior specialist takes it from there.
If existing data has to be reviewed before a price can be fixed, we say so on the call. That review is a readiness check: $3,650, yours to keep, and credited to your plan.
What you can count on
Four surprises we take off the table, and a plain list of what the price covers.
No surprise on the invoice
One fixed price, set in your written plan before billing starts and paid in equal monthly instalments.
No surprise on the schedule
We run the laboratories and the milestones. Your portal shows who is doing what, and when, every week.
No surprise bill when a regulator asks
Regulators ask questions; nobody can promise otherwise. What we promise is the answer. On plans of a year or longer, if FDA or your Notified Body questions work we wrote, we prepare the response at no charge, within the limits set out in your agreement.
No passing you around
One named senior specialist from the first call to the last report. A name and a phone number, not a ticket queue.
In the price
- Writing the documents: plans, protocols, assessments, risk files and reports
- Choosing, booking and managing the laboratories
- Answering a regulator's questions on work we wrote, within the limits in your agreement
- A named senior specialist, and the portal that shows who is doing what
- The first 30 days of any delay on your side
Not in the price
- The laboratory testing itself. It is quoted in your plan at partner rates, before you approve anything
- Agency, sterilizer and Notified Body fees
- Writing or filing a 510(k). We hand the evidence to your regulatory lead
Questions people ask before they start
What is SafetyStack?
Device safety through design controls and the safety sciences, done for you by one team. Design controls are quality engineering and risk management. The safety sciences are cleaning and sterilization, packaging and shelf life, biocompatibility and toxicology. We write the files, run the laboratories and sign what we deliver, for one fixed price paid monthly.
What is the difference between Full Stack and Custom Stack?
On Full Stack we own all six areas for a new device, start to stop. On Custom Stack you run the program and choose the areas we own. Both are priced from the same rates and fixed in a written plan.
How is the price worked out?
From three things: which areas we work on, in which months, and how complex the product is. Each area has its own monthly price, because the experts differ: toxicology costs more than quality engineering. Your written plan shows the phases, the number of months and the fixed monthly price, before anything is billed.
What does a whole program come to?
That depends on your project: the monthly price times the months in your plan. The monthly price is the fixed part. How many months, and which areas are at work in each, come from your device and your schedule, so the whole figure is different for every project. Your written plan states the months, the scope and the monthly price before anything is billed, and a change to the scope or the months is agreed in writing before it changes what you pay. Laboratory testing is priced separately.
Is the written plan always free?
For most devices, yes: the call and the plan cost nothing. If existing data has to be reviewed before a price can be fixed, we say so on the call. That review is a readiness check at $3,650. The report is yours to keep, and the fee is credited to your plan.
Is laboratory testing included?
No, and we tell you the number early. Testing runs through our qualified laboratory network under our quality system, at partner rates. Your written plan carries the testing estimate for your device before you approve anything. Agency, sterilizer and Notified Body fees are not included either.
Can we pay month to month instead of signing for a year?
Yes, on Full Stack, Custom Stack and Keep Current. Month to month costs 25% more than the 12-month price, with a one-time setup fee equal to one month and a 3-month minimum, then 30 days' notice. A 12-month agreement is 20% less and has no setup fee.
What if the plan needs to change?
A change to the product or the scope gets a written change to the plan, with its own fixed price, before any extra work starts. Areas can be added at any time.
What if our own schedule slips?
The fixed price covers the work in your plan. If your design or build schedule slips, the first 30 days cost nothing. After that, a written change sets the new dates and prices the extra months of the areas still at work, at their monthly price. You see and approve it before anything more is billed. A delay on our side never costs you anything.
What does a Keep Current price include each month?
Up to 15 hours of expert time for each area you keep current, a written assessment of each change within 5 business days of receiving the details, and updates to the files when a standard is revised. If a month needs more than that, for example a change that calls for new testing or a rewritten file, we quote the extra before it starts.
What if we stop early?
The plan is divided into phases. If you stop, you pay for the phases completed and the phase in progress. The full terms are in the agreement you receive with your plan, before you approve anything.
Is there a deposit?
Companies without a credit rating pay a two-month deposit. It is applied to the last two months of the plan.
What does the promise on regulator questions cover?
On plans of a year or longer, when a written request from FDA or a Notified Body questions a document we wrote, we prepare the response at no charge, within the limits set out in your agreement. Anything outside that uses the Deficiency Response Pack at $12,500 per letter. It is a promise about our response and your bill; nobody can promise that a regulator will not ask.
Do you file the submission?
We build the evidence and hand it to your regulatory lead ready to file. We do not write or file 510(k)s. We do build full EU MDR technical files.
Who does the work?
A vetted team of subject matter experts, one for each area, with every deliverable reviewed and signed by a named senior specialist. Toxicological risk assessments are reviewed by a board-certified toxicologist (DABT). You remain the legal manufacturer and approve every record.
What counts as a product, and what if we have more than one?
A product is one device or material family under one design file. Each product has its own plan. A second product on the same plan is 75% of the first.
What makes a product complex?
An implant, contact with the body for more than 30 days, a combination product, or more than five materials that touch the patient. One of these makes the price about 1.5 times; two or more are quoted individually.
Who is SafetyStack not for?
Companies that want to pay only when they use it, programs that are really a clinical trial, and companies with no one to approve records. You remain the legal manufacturer.