First MDR assessment
Deficiencies raised in the technical documentation review while you work towards your first MDR certificate.
Findings response · EU MDRStuck in review?
Stuck in review?
We get you through.
Your Notified Body came back with deficiencies on your technical documentation, and your certificate waits until every one is answered. We work through them with you, write the responses and get your MDR certification moving again.
Start today- NDA before you share anything
- Fixed quote within 48 hours
- Human experts
4
of 12 deficiencies still open
- ClosedDeficiency 03Clinical evaluation report
- SubmittedDeficiency 07Risk management file
- DraftingDeficiency 09Software validation evidence
- PlannedDeficiency 11Labelling and IFU
Regulatory certainty when it counts
Companies across markets trust Dovetail with their most complex, life-saving medical devices.
Our clinical evaluation came back with zero nonconformities. Everything’s been resolved, from 29 down to 0. We couldn’t have gotten here without Dovetails help.
Case study · Apoplex
290
Deficiencies resolved in their MDD to MDR conformity assessment, after one round of updates and review.
Read the case studyA senior regulatory team in your corner, from day one to approval.
Closing deficiencies takes people who have done it many times before. That’s who works on your responses.
Real people
Your responses are written by senior regulatory and quality leads who hold ISO 13485:2016 Lead Auditor, RAC (Devices), ASQ quality and CCRP certifications. Not a chatbot, not a report.
EU MDR
ISO 13485
- ASQManager of Quality / Organisational Excellence
- ISOISO 13485:2016 Certified Lead Auditor
- ASQCertified Quality Engineer
- RACRegulatory Affairs Certification – Devices
- ASQCertified Software Quality Engineer
- CCRPCertified Clinical Research Professional
- Successful certifications
- 80+
- Audit success rate
- 100%
- Average avoided costs
- €70K+
Is your MDR conformity assessment stuck on deficiencies?
You submitted, your Notified Body came back with deficiencies, and the response window is running. We have you covered no matter the situation.
MDD to MDR transition
Deficiencies on a device you already sell under MDD, with the 2027 and 2028 transition deadlines getting closer.
No one to close them
A long list of deficiencies, and nobody with the time or MDR expertise to close them before the deadline? We got you.
Why usYou don’t need another report.
You don’t need another report.
You need the deficiencies closed.
Every response is reviewed by a certified lead auditor before it goes to your Notified Body, so it reads the way a reviewer expects.
A typical gap reviewWith Dovetail
- Tells you what’s wrong
A response plan for every deficiency
The answer, the evidence and the document changes, mapped to each question.
- Bills by the hour, open-ended
Fixed price, agreed before we start
From $45,000 for the full response. No hourly billing, no surprise invoices.
- Hands the fixes back to your team
We correct the documents ourselves
Technical file, CER, risk file. We do the edits, not just mark them up.
- Leaves the Notified Body to you
We talk to your Notified Body with you
We write the responses and join the calls when it helps.
- Comments in a PDF, sent by email
We work with you in a shared Slack channel
Quick answers from the people doing the work, not a weekly check-in.
- Ends when the report is delivered
We stay until every deficiency is closed
Follow-up questions from the reviewer are part of the job.
From 25 Feb 2027You only get so many tries.
You only get so many tries.
Every response has to count.
Under EU Regulation 2026/977, Notified Bodies have 90 days and at most four clock stops to review your technical documentation. There’s no room for a response that misses.
How it works
From deficiency list to MDR approval
- 1
30-minute call
Your device, your Notified Body, how many deficiencies and the deadline.
- 2
Deficiency list review
We sign an NDA, you send your Notified Body’s deficiency list.
- 3
Fixed quote in 48 hours
We triage every deficiency and tell you what’s in scope and what isn’t.
- 4
Plan and fix
A regulatory lead, a shared Slack channel, a deficiency tracker and a plan per deficiency with owners and dates.
- 5
Submit and close
Responses go to your Notified Body and we track each deficiency until it’s closed.
Real experts, not softwareFixed price from $45,000, agreed up frontFixed quote within 48 hours
Start todayWorks with your setup
However you’re set up, we slot right in
In-house team, outside consultant or nobody at all. We fit around what you have.
You have an in-house team
I’ve got the people. I need extra hands.
We add specialist judgement and capacity for the deficiency responses. Your team keeps ownership.
You already have a consultant
My consultant can’t close these.
We take on the deficiencies they can’t close, or run a clean handover if you need one.
Nobody owns it right now
Our RA lead is gone. We need it done.
Your RA lead left or never existed. We step in and do the work, not just advise on it.
Frequently Asked Questions
The questions we hear most from teams answering Notified Body deficiencies. If yours isn’t here, get in touch.
That’s the situation we’re built for. Before anything is submitted, a lead certified auditor reviews every response against what your Notified Body asked for. We start with the deficiencies most likely to block closure, fix the substance rather than the wording, and don’t send anything we wouldn’t defend in the review. If the deadline doesn’t leave time to do it properly, we tell you up front and help you decide whether to ask for an extension.
Yes. Many deficiencies come from a strategy that doesn’t hold up, like a clinical evaluation route that doesn’t match the literature search behind it. We fix the underlying approach, then write responses that are consistent with it.
Talk to your Notified Body early. An extension is often possible if you ask before the deadline, but every round counts, so we plan one complete response that answers every open question.
You get a fixed quote within 48 hours of sending us your deficiency list. Once it’s signed, a regulatory lead is assigned and the review of your documentation starts that week.
We do the regulatory work. You give us access to your documentation, a named contact, and your engineers for the technical evidence only they can provide. We work together in a shared Slack channel and run short, regular syncs until every deficiency is closed.
No one can. What we commit to is a properly evidenced response to every deficiency in scope, and we stay with it until your Notified Body closes them.
Findings call
The response clock is running. Let’s get started.
Pick a time for a 30-minute call with a senior regulatory lead. Tell us what your Notified Body raised and when it’s due, and you’ll have a fixed quote within 48 hours.
Your documents stay private, under NDA and strict access controls.
