Your technical file has never been read by anyone who has refused one.
The MDReady Report is a fixed-price consulting service for medical device manufacturers that are preparing EU and UK technical documentation for regulatory submission. It can be delivered remotely to any company in any location, by our former notified body technical expert.
Regulatory Affairs ConsultingWhich of these are you?
The ServiceWhat you get
A fixed price for a full evaluation of your technical documentation - including clinical evaluation - by someone who spent nearly seven years assessing files like yours at a leading notified body. The recommendations are ordered by certification impact and resource draw, not just by regulatory reference.
The findings can often be applied across a portfolio too, and your regulatory staff gain insights that are only available from a former notified body reviewer.
The service includes a meeting to discuss the findings and recommendations. The report is typically delivered within 2-4 weeks of the agreed start date.
Our price for this service is agreed in advance and fixed - meaning you are not signing up to open-ended consulting fees.
The MDREADY REPORT DELIVERABLESA statement of the likely assessment outcome.
A readiness score in each of eleven technical areas.
Ranking of gaps and recommendations by commercial impact, covering timeline, cost, resource intensity and commercial risk.
Separately detailed information about the gaps and recommendations, each with an impact identified.
In DetailThe Report
Readiness Scale0 / No gaps or clarifications.
1 / Clarifications for a smooth assessment.
2 / Minor gaps.
3 / Major gaps, addressable by documentation
4 / Major gaps, requiring testing.
5 / Substantial risks.
ContentsExecutive Summary
Section A: Prioritised Recommendations
Section B: Detailed Findings
Section C: How We can Help
Appendix A: Documentation references
Appendix B: Prioritisation scoring
Appendix C: Glossary
ObjectionsWhy Not? Here’s Why.
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Day rates for NB technical documentation audit are high - we found an average published day rate of ~€2950, with a higher average of €3411 for leading NBs. These are just the publicly available prices - higher priced services are usually available, offering queue jumping or on-site review of technical documentation.
Our fixed fees are a fraction of the overall NB costs - and designed to be less than the additional assessment costs incurred when the NB has to ask additional questions associated with a difficult technical file.
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Regulatory affairs (RA) integrates and assembles documentation; it does not originate all of it. I am not just an RA expert, I am an end-to-end medical device expert, and I bring assessor-level scrutiny to the full technical documentation. This is an audit of multidisciplinary inputs, not an audit of the RA department.
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Guidance is just that - guidance. It’s not exhaustive. Notified body technical experts take a holistic approach across all areas of technical documentation. After guidance, the residual factor is judgement; and this can only come from a former assessor, because current NB employees cannot consult.
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You’re right - and that’s why our MDReady Report is risk based. It gives you a map of the gaps and recommendations, leaving decisions about cost-benefit of addressing those gaps in your hands. It’s still your decision, just more informed.
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This is fully covered by our contract. Documentation is transferred to us securely for review (we can even access it remotely if you prefer). Having previously worked at a notified body, we are used to highly confidential environments and keeping information separate.
What the MDReady Report is not.
This is not a document completeness checklist - it’s a holistic, detailed evaluation.
This is not a QMS gap assessment - it is an evaluation of a specific device’s technical documentation.
This is not an open-ended consulting project - it’s a fixed-scope, fixed-price engagement.
This is not a regulatory strategy consultation - that should be much earlier in a project.
This is not a guarantee of certification - it is a highly informed professional opinion.
We do not provide this service for active devices - they are outside our area of competence. We cover non-active devices, both implantable and non-implantable.
OUR PEOPLEJoseph Langley MEng CEng MTOPRA
~5 years designing and manufacturing implantable and surgical devices, ~7 years as a technical expert at a leading notified body. Turbocharged with a highly motivated interest in connecting technical and commercial factors.
We need just five pieces of information to send your proposal:
Brief device description
Classification
Conformity assessment route (e.g. Annex IX)
Description of variants (sizes etc)
Description of manufacturing facilities & sites
Would you rather find out now, or in the questions round?
We respond in 48 hours.
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An assessment of the device’s technical documentation, with content per Annex II and III of EU MDR, against the Annex I GSPRs (and other applicable requirements from the legislative text).
It goes beyond the QMS assessment, which looks at procedures and records, to check that the output technical documentation and actual device are compliant with the Regulation.
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The billable days varies depending on device classification and complexity, but the process can take an average of 13-18 months (2025 Team NB Survey).
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No. Notified bodies cannot look at the file before they start the formal assessment, and they cannot consult. This means that whilst they can issue non-conformities and deficiency questions, they cannot advise on how to address them. This is where a competent consultant like Brightbark Cranberry can help you.
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We offer a variety of mock audits, which are designed to be a simulation of a real notified body audit. They offer both the opportunity to find gaps, and experience for your staff (along with coaching after the mock audit).
This is a fixed scope gap assessment, designed to evaluate the readiness of the technical file for a particular device.