Medical Device Engineering & Compliance

Built Right.
Tested Right.
Cleared Right.

We don't just file paperwork — we engineer medical devices that pass. From rapid prototyping and FMEAs to IEC 60601 electrical safety and test house navigation, we solve the hard technical problems that get your device to market.

IEC 60601 Expert Rapid Prototyping FMEA / Risk Test House Navigation Intertek · UL · TÜV FDA · EU MDR · Global
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IEC 60601-1 FMEA
IEC
60601 Expert
FMEA
Risk & Analysis
Proto
Rapid Development
Global
FDA · EU MDR
IEC 60601-1 / 60601-1-2
Rapid Prototyping
FMEA · ISO 14971
Intertek · UL · TÜV · CSA
FDA 510(k) · PMA · EU MDR
Class I · II · III
Capital & Disposable Devices
Why We're Different

Engineering Expertise First.
Regulatory Second.

Most regulatory consultants know the rules. We know how to build the devices that follow them. That combination — deep engineering skill paired with regulatory mastery — is rare, and it's why our clients pass.

01

We Solve the Hard Technical Problems

When your device stalls at a design challenge — EMC failures, leakage current, isolation issues, FMEA complexity — we diagnose and fix it. We're engineers who know compliance, not compliance people who dabble in engineering.

02

We Build Before We Submit

Regulatory strategy that ignores engineering reality wastes time and money. We design with the submission in mind from day one — right material selection, right architecture, right test plan — eliminating costly late-stage redesigns.

03

We've Walked the Test House Floor

We know what Intertek, UL, TÜV, and CSA engineers are looking for — because we've been through it dozens of times. We prepare your device so there are no surprises when it counts most.

The Rapid Documentation Advantage

The Job Isn't Done
Until the Paperwork Is Done.

Most companies finish the device and then spend 6–12 months catching up on documentation. DHFs are incomplete. Risk files are thin. V&V protocols weren't written before testing started. We deliver the hardware and the documentation — simultaneously, at speed.

Global Engineering Network

Engineers on call across disciplines and time zones — mechanical, electrical, software, quality. No hiring delays. No onboarding. Surge capacity exactly when you need it to hit your deadline.

×

AI-Assisted Documentation

AI-accelerated drafting, review, and formatting of protocols, reports, risk files, and DHF documents. First drafts in hours, not weeks. Expert engineers review and validate every output before it leaves our hands.

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Regulatory Precision

Every document written to FDA 21 CFR Part 820, EU MDR Annex II/III, ISO 13485, and ISO 14971 from the first draft — no rework cycles, no deficiency letters from incomplete documentation.

3×
Traditional Approach
Development
6 months
Doc catch-up
9 months
Submission
3 months
Total time to submission18 months
Compliant Solutions
Dev + Docs parallel
5 months
Doc catch-up
NONE
Submission
2 months
Total time to submission7 months
See Rapid Documentation Services Talk to Us About Your Timeline

Have a technical challenge slowing your device down?

Talk to an engineer who has solved it before — no obligation, no sales pitch.

Talk to an Engineer
FAQ

Common Questions

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The earlier the better — ideally at concept stage before design decisions are locked in. The cost of embedding compliance into your architecture from the start is a fraction of the cost of redesigning after a test failure. That said, we regularly step in mid-development or at the test-house stage and quickly assess where you stand and what needs to change.
It means moving from idea to testable hardware quickly — but with compliance built in, not ignored. We structure design sprints so each iteration moves toward a device that will pass both functional and regulatory tests. This includes early electrical safety design, material selection with biocompatibility in mind, and architectures that make V&V straightforward. Speed and compliance aren't opposites — with the right approach they reinforce each other.
Absolutely — this is one of the most common ways we engage. Teams come to us with a specific hard problem: leakage current that won't come down, EMC pre-scans that keep failing, an FMEA that's grown unmanageable, or a usability issue blocking V&V. We can scope a focused engagement around a single challenge without taking over the whole project.
Our core strength is hardware and systems engineering — electrical safety, mechanical design, EMC, and the physical device. For software, we provide regulatory guidance on IEC 62304 software lifecycle documentation, software risk management, and SaMD classification, and we can recommend trusted software engineering partners when dedicated development resources are needed.
IEC 60601-1 is the international standard for basic safety and essential performance of electrical medical equipment. If your device is electrically powered and intended for medical use, compliance is almost certainly required for both FDA clearance and CE marking. The standard covers electrical shock hazards, mechanical hazards, radiation, flammability, and more. Collateral standards (the "-1-x" series) and particular standards ("-2-x") add requirements specific to your device type or environment.
MOPP (Means of Patient Protection) applies to isolation in parts of the device that could contact patients — stricter requirements because patients may be more vulnerable. MOOP (Means of Operator Protection) applies to operator-accessible parts with less stringent requirements. Getting MOPP/MOOP classification wrong is one of the most common IEC 60601-1 design errors we see — it affects isolation voltage, creepage and clearance distances, and leakage current limits throughout the entire design.
Leakage current failures are almost always design issues, not manufacturing defects. Common root causes include:
  • Excessive Y-capacitor values on the EMI filter (very common)
  • Incorrect MOPP/MOOP classification leading to wrong current limits
  • Poor isolation transformer design or missing reinforced insulation
  • Parasitic capacitance paths in PCB layout to chassis
  • Missing or undersized isolation barriers between patient-connected and mains circuits
We've diagnosed and resolved all of these — often without requiring a full board redesign.
IEC 60601-1-2 is the collateral EMC standard specifying emissions and immunity requirements for medical electrical equipment. EMC matters because medical devices operate near other electrical equipment, radio transmitters, and RF sources — and a device that malfunctions due to electromagnetic interference is a patient safety risk. The 4th edition significantly increased immunity requirements and introduced risk-based testing. We help teams navigate both the technical design requirements and the documentation burden this standard creates.
Key factors: target market, device type, budget, and timeline. For the U.S., any OSHA-recognized NRTL (Intertek, UL, MET, CSA) works for electrical safety. For EU CE marking, Class IIa and above require a Notified Body — some also offer testing (TÜV SÜD, TÜV Rheinland, BSI). Turnaround times vary enormously — some labs have 3-month backlogs. We know which labs are fastest for specific test types and can help you select strategically and scope testing to avoid paying for unnecessary tests.
In our experience, the most common causes of first-time failures:
  • Leakage current over limits due to EMI filter Y-cap values
  • Insufficient creepage and clearance on PCB or in enclosure
  • EMC emissions failures from unshielded cables or poor layout
  • Incomplete documentation — missing risk file, wrong test configuration
  • Wrong standard edition — testing to an outdated version
  • Insufficient immunity margin — device functions but essential performance degrades
Every one of these is preventable with proper pre-compliance preparation.
Yes — and we strongly recommend it for complex devices. Having someone on-site who can interpret results in real time, communicate with test engineers, and make rapid engineering decisions when something fails is enormously valuable. The alternative — failing, waiting weeks for a new slot, fixing at home, retesting — can add months to your schedule. We can attend in-person or provide real-time remote support depending on your location and needs.
510(k): For most Class II devices. Demonstrates substantial equivalence to a predicate. Fastest Class II path — typically 6–12 months from submission.

De Novo: Novel Class II devices without an appropriate predicate. Creates a new classification — more rigorous than 510(k), less than PMA. Typically 12–18 months.

PMA: Most Class III devices. Requires clinical data proving safety and effectiveness. Most demanding path — 18–36+ months, but required for high-risk implantable and life-sustaining devices.
FDA clearance is supportive evidence but does not substitute for EU MDR compliance. The two systems have different requirements — EU MDR places particular emphasis on clinical evidence, post-market surveillance, and Technical Documentation in a specific format. That said, the testing data and documentation from your FDA submission (biocompatibility, EMC, electrical safety, etc.) can typically be leveraged for the EU Technical File, saving significant effort if structured correctly from the start.
  • FDA 510(k): 6–12 months from submission
  • FDA De Novo: 12–18 months
  • FDA PMA: 18–36+ months
  • EU MDR Class IIa/IIb: 12–24 months
  • EU MDR Class III: 24–36+ months
These assume complete, well-prepared submissions. Deficiency letters from incomplete documentation add months. Our preparation process is designed to minimize review time and eliminate back-and-forth.
We start with a free discovery call to understand your device, markets, current stage, and specific challenges. From there we assess and develop a scoped project plan with clear deliverables and pricing. Engagements range from targeted problem-solving (a specific IEC 60601 issue, FMEA development, test house prep) to full project support from prototype through submission. We scale to your team size and stage.
Both — and we genuinely enjoy working with founders new to medical device development. Getting engineering and regulatory strategy right early saves enormous time and money. We calibrate our approach: an early-stage startup gets the foundational strategy they need without paying for complexity they don't yet need; an established manufacturer gets the depth a complex Class III PMA or EU MDR submission demands.
Absolutely. We frequently step into in-flight projects — a device stuck at the test house, a 510(k) that received an FDA deficiency letter, an EU MDR Technical File that stalled, or a QMS that failed an audit. We assess what exists, identify gaps, and build a clear remediation plan. We can also supplement an internal team needing extra bandwidth or specific expertise for a phase of the project.