Answers for Apple + Google medical-device declarations

Clear answers for Apple and Google medical-device declarations.

Medical-device declarations, ready to submit.

Bring the product facts you know. We assess the United States, Great Britain, and EU/NI paths, prepare your Apple and Google answers, and stay with the declaration if the platform writes back.

Free · no paymentGet a free scope checkFour questions. See an estimate immediately.Start free Ready to buyGet my official priceSkip the check. Most products get a payable price on the spot.Start now
United StatesGreat BritainEU/NIOne-time payment

Included follow-up help

If Apple or Google asks a follow-up, we help you answer.

Included with every Answer Pack

We guarantee the medical-device declaration work we prepare for the agreed product, version, markets, and disclosed facts. If Apple or Google challenges our answers, we answer it and revise our work at no extra charge — up to three times, with no expiry date, for as long as the product, version, markets, disclosed facts, and review units stay the same. Our own errors are corrected free outside that limit.

The rest of the app remains a separate review: bugs, privacy, payments, account status, and general content-policy issues can still cause rejection and are outside this guarantee. Certification, registration, or another formal prerequisite is also a separate service. Our total liability for the work is limited to the fees paid for it.

What you receive

Your Answer Pack. Three ways to move forward.

One connected review—made practical for submission, clarity, and future questions. Your customer files are downloadable; the public sample is view-only.

One connected reviewThree practical outputs
01Submit

Copy-ready answer sheet

The recommended Apple and Google responses, separated from the reasoning and ready for your team to transfer.

02Understand

A plain-English summary

The detailed PDF opens with the market findings, open items, and exactly what happens next before the technical record begins.

03Defend

A detailed report

A downloadable, source-traced record of the functions, evidence, reasoning, and re-review triggers.

Why the answer holds up

Built to stand behind. Clear from the start.

The Answer Pack does more than state a result. It keeps the product facts, market path, evidence, reasoning, and open points connected in one review record.

Open the view-only sample
01

Built for your market

United States, Great Britain, and EU/NI findings stay separate when their legal paths diverge.

02

Built around your product

Each relevant function is reviewed against the product facts, public claims, and materials you provide.

03

Built on visible evidence

The sources, reasoning, open items, and facts that could change the answer remain visible in the record.

How it worksNo regulatory expertise required.

Four simple steps. That’s it.

Tell us what you know. We organize the rest and return finished answers.

01

Tell us what your app does

Plain English, one line per function. Start with the free scope check, or go straight to a price — both begin the same way.

02

See your price

Most products get a final, payable figure on the spot. The rest are confirmed by a reviewer and emailed within 24 hours.

03

Structured review

We assess each relevant function by market and check the evidence and public claims. Every Answer Pack is checked before delivery.

04

Answer Pack + aftercare

Receive the finished answers within five business days of payment when no further information is needed, or within five business days after your final requested answer. If the platform writes back, up to three declaration follow-ups are included.

Not sure? Bring what you know. We’ll guide the rest.

Share the facts and materials you have. If a missing fact could change the result, we ask before finalizing your Answer Pack. You’ll receive one clear, consolidated request from us, and “I’m not sure” is always a valid answer.

Sample Answer Pack

Illustrative answer packCase 001 / SleepWell
Reviewed finding

Three separate market findings, connected to one review record.

Evidence5 / 5 channels accounted for
MarketsUnited States · Great Britain · EU/NI
Open itemsNone in the illustrative record
Public preview · view only

Open a real deliverable structure

See exactly where the answer comes from.

Walk through the clear answer, declaration check, function table, evidence record, copy-ready responses, source trail, and re-review triggers in one fictional case.

Open the illustrative sample

A fixed scope before you pay

Clear scope. One-time payment. Support included.

You do not need to count regulatory functions. Describe the app in your own words, and we group them, explain the grouping, and show the exact price before payment — whether you start with the free check or go straight to a quote.

Standard Answer PackOne-time payment
$399 USD
  • Five business days from payment, or from your final requested answer if we need more information
  • One app and current version
  • Apple + Google responses
  • United States + Great Britain + EU/NI
  • Up to three regulatory review units
  • Answer Pack checked before delivery, with a source trail
  • Declaration-specific support on platform questions
Units 4–5+$99 each6+ or unusual complexityCustom quote
Before you paySee this price confirmed for your appNo payment until the scope is agreedGet my price

Included

A focused service for Apple and Google declarations.

  • Apple medical-device declaration review
  • Google Play health-app declaration support
  • United States, Great Britain, and EU/NI qualification review
  • Review of the product facts and materials provided
  • Declaration-specific support on platform questions

Not included

Clear boundaries make the promise credible.

  • CE or UKCA marking, FDA submissions, or notified-body work
  • Issuing registrations, certifications, SRNs, UDI-DIs, or approvals
  • Medical-device class in the standard launch pack
  • Full IFU, QMS, clinical evaluation, or risk-management files
  • Privacy, GDPR, HIPAA, legal advice, or whole-app approval

Common questions

Before you start.

Do I need to understand medical-device regulation?

No. You provide facts you already know: what the product does, what users see, where it is available, and what materials exist. We do not ask you to interpret regulatory terms.

What if I do not know an answer?

Choose “I’m not sure.” We review what you submitted and send one clear, consolidated request for anything else needed. Missing information is never turned into a guessed answer.

Will you send a final Answer Pack if something is still unresolved?

No. Declaration Desk does not send an unresolved assessment as a final result. If a missing fact could change the result, we ask before finalizing your Answer Pack.

What is a regulatory review unit?

It is one product function, or a group of functions, that can be assessed together because it has the same purpose, inputs, outputs, and likely regulatory path. Login, settings, payment, and similar operational utilities do not count. You do not have to count units—we propose the grouping in the free scope check.

What is included in the USD 399 standard pack?

One app and current version, Apple and Google, the United States, Great Britain, and EU/NI qualification review, and up to three regulatory review units. Units four and five are USD 99 each. Six or more units, or an unusually complex product, receives a custom quote before payment.

Do you submit the forms for us?

No. Your team keeps control of its Apple and Google accounts. We provide organized, copy-ready responses and supporting notes for your team to enter.

Do you guarantee approval?

No. We do not guarantee store approval — that decision is the platform’s. What we do commit to is this: for the same product, version, markets, disclosed facts, and review units, if Apple or Google come back with a question about the declaration, we answer it and revise our work at no extra charge — up to three times, with no expiry date. One platform question and our related reply-and-revision package counts as one. Our own errors are corrected free outside that limit. An app can still be rejected for unrelated issues such as bugs, privacy, payments, account status, or general content policy. Certification, registration, and other prerequisites are separate services. Our total liability for the work is limited to the fees you paid for it.

What if a fact or the delivered pack is wrong?

We correct our own error free of charge. If you supplied one fact incorrectly, the first factual correction requested within 30 days of final delivery is included when it concerns the same product, version, markets, and agreed scope. New features, claims, markets, versions, or a second factual correction may require a new quote.

How long does it take?

We first review the information already submitted. If a result-changing fact or supporting item is missing, we send one consolidated secure request; some orders need no additional request. Delivery is within five business days of payment when no request is needed, or within five business days after your final requested answer or item is received. Until every requested item is received, that five-business-day period has not started and we cannot guarantee a delivery date. If an item is still unanswered after seven calendar days, we send one reminder. A business day is Monday to Friday, excluding public holidays observed at the seller's registered business location, using Asia/Seoul calendar dates. If we miss the applicable deadline, you get a full refund.

How do refunds work?

If you change your mind before substantive review begins, you can cancel for a full refund. Substantive review may begin after payment without a separate start email. Once it begins, change-of-mind refunds are not available, except where applicable law requires otherwise. If we miss the applicable delivery deadline, do not deliver, or do not cover the scope you paid for, you get a full refund. Included platform follow-up and our-error correction rights remain available after delivery.

How is confidential information handled?

Only designated reviewers access submitted materials. Do not send patient records, real user health data, credentials, or confidential source code. Local working copies are deleted within 90 days after final delivery, or earlier on request. Before PayPal opens, we also record the accepted terms version, price lines and scope boundary shown before payment against the PayPal order id, without customer-name, email, company, IP-address or user-agent fields. That order-evidence record is kept for 5 calendar years after acceptance, as required by applicable e-commerce record-keeping law, then deleted.

Helpful guides

Understand the questions before you answer.

Plain-English explanations, with official sources, for the three market routes and the two store forms.

Still need help?Tell us what you are trying to do and include your quote or case reference if you have one.
help.dd@jogak.studio

Two ways to start

Start with what you know.

Both routes end in the same fixed-price quote, with the scope written out before you pay. The only difference is how much you want to see first.

Free · no paymentFree scope checkFour questions about your app. You see an estimate and the reason for it straight away, then continue when you are ready.Start the free check Ready to buyOfficial price nowDescribe your functions once. Most products get a final, payable price on the spot; the rest are confirmed by a reviewer and emailed within 24 hours.Get my official price