Regulatory and quality consulting for medical devices
We help medical device companies reach the US and EU markets: the regulatory route, the quality system, and the submission itself. Working with manufacturers on both sides of the Atlantic since 2018.
About SanitasMed
Who we are
SanitasMed is a regulatory affairs and quality consultancy, established in 2018. We get our clients’ devices onto the market in the United States and Europe and keep them compliant throughout their lifecycle.
Most of our clients are start-ups and small manufacturers building novel products: implantables, wearables, software as a medical device. They need senior regulatory judgement at specific moments. We provide the judgement, and the documentation to back it up.
You work directly with the people doing the work. We tell you early when a plan will not hold, we scope engagements to the stage you are actually at, and we stay on the file until there is a decision. We work remotely across the US and EU, on-site when development or an audit needs us in the room.
Client devices taken through approval in Class II and III, including active implantables and software.
One route that covers both markets, sequenced so neither blocks the other
We prepare the questions, write the submissions, and sit on calls with you.
Compliant systems that a small team can actually run, and keep running after certification.
Complete, traceable, review-ready files, structured the way reviewers expect to read them.
Post-market surveillance, change management, and re-certification as the regulations move.
What we can take off your plate
Services covering the regulatory lifecycle of a device
- Know which markets to target, in what order, and what each will demand.
- Support in defining regulatory strategy
- EU market access
- US market access
- Input for milestone planning
- A submission is only as strong as the file behind it. We compile the evidence, submit it, and answer the questions that coma back.
- Summary Technical Documentation (STED)
- 510(k) compilation
- Submission support
- Find out where you stand before an auditor or a reviewer tells you. You get a prioritised list of findings and what closes each one.
- Technical documentation review
- Quality system review
- A QMS should fit how your team already works. We draft it, implement it, and keep it audit ready as you grow.
- ISO 13485:2016
- 21 CFR 820
- MDR 745/2017 EU
- ISO 14155
- IEC 62304
- ISO 27001
- The right electronicc QMS saves a small team hundreds of hours. The wrong one becomes a compliance problem of its own.
- Support in selecting the adequate tool for your team
- Process adaptation
- Implementation
- Audits are predictable if you prepare for them. We get you ready, stay beside you during, and help close the findings.
- Conducting Internal Audits
- Support in External Audits
- Support in resolving audit findings
- Conducting Supplier Audits
- We use enterprise-grade AI assistants to draft regulatory documentation faster under a controlled process, with a qualified regulatory professional accountable for every document.
- Accelerated drafting of QMS procedures and technical documentation
- AI supported gap analysis
- Documented human review and approval on every output
- Confidentiality controls: your data is never used to train a model.
How we use AI and where the human stays in charge
Writing a quality system means producing a great deal of structured, repetitive text. AI assistants are genuinely good at that part, and we use them for it.
A qualified regualtory professional sets the scope of every document, reviews every line against the applicable standard, corrects it, and approves it. Nothing is submitted, and nothing reaches your eQMS, on a model’s authority.
The frameworks we work in
Guiding You Through Every Step
Built for your device and your target geographies, not adapted from a template.
We build and audit client quality systems against ISO13485, FDA QMSR, EU MDR 2017/785, ISO 14155, IEC 62304, and ISO27001.
STED and technical documentation, 510(k), CE marking, clinical trial and EFS applications.
Q-submissions, classification requests, meeting preparation, and the follow-up after.
- Class II & III (EU)
- Class 1, II & (US)
- SaMD (Software as a Medical Device)
- Active Devices
- Active Implantable Devices
Work we have done
Real devices, real frameworks, real market access
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A Dutch start-up with a novel sleep monitoring device replacing standard lab polysomnography devices with both the EU and US markets in scope. We worked with them from their earliest days through the market access in both regions. With us, the client:
- Obtained ISO 13485:2016 Certification
- Secured CE Mark under MDD 93/42/EEC
- Achieved 510(K) Market Clearance
- Updated QMS to MDR 2017/745 EU
One device, cleared for sale in the EU and US, and a quality system suitable for both markets.
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To bring an implantable neuroprosthesis into clinical use, our Dutch client needed ethics committee approval for their first in human trial and the quality and documentation foundation to support its next endeavors. We provided:
- eQMS implementation
- QMS Processes (ISO 13485 & 21 CFR 820)
- Technical Documentation
- Regulatory Strategy
A documentation and quality foundation strong enough to carry an implantable device into clinical use.
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A first-in-human early feasibility study, requiring clinical trial approval from both FDA and an EU authority. We supported the submission with:
- Review biocompatibility test strategy and reports
- Organizing manufacturing information for submission
- Compile testing and risk evaluation information
A study package accepted for review by the FDA.
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A Swiss manufacturer targeting the US market needed a quality system lean enough for a small team but robust enough for FDA expectations. We built it with them:
- Implementing an eQMS System
- Lean QMS Processes
- Technical Documentation
- Regulatory Submission Files
- Supplier Qualification
- EU Notified Body Interactions
An audit-ready quality system sized for the company that has to run it.