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Compare medical device consultants for FDA 510(k), De Novo, PMA, QMS (ISO 13485), and risk management (ISO 14971). Request quotes and connect with vetted providers.
- 510(k) submission strategy and authoring
- FDA Pre-Sub, eSTAR, and RTA support
- Medical device regulatory and quality consulting
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What is medical device consulting?
Medical device consulting is professional advisory support for companies that design, manufacture, or distribute medical devices. Consultants help you navigate regulatory requirements, quality systems, and submission pathways so you can bring products to market and maintain compliance.
The FDA defines medical devices broadly: instruments, apparatus, software, or other articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or function of the body (FDA, Device Registration and Listing). Consulting in this space typically covers:
- Regulatory strategy — Choosing and executing the right pathway (e.g. 510(k), De Novo, PMA) and staying aligned with FDA expectations.
- Submission preparation — Planning and authoring premarket submissions, including predicate analysis, substantial equivalence, and required documentation.
- FDA communication — Pre-Sub (Q-Sub) meetings, responding to Refuse-to-Accept (RTA) or Additional Information requests.
- Quality and risk — Quality Management Systems (QMS), risk management, and inspection readiness under FDA and international standards.
Medical device consultants often work with startups, established manufacturers, and distributors. Many serve clients nationwide; what matters most is fit for your device type and regulatory pathway. Throughout this page we cite FDA and ISO sources so you can verify the regulatory context; see Sources and references at the bottom.
Why use a medical device consultant?
Manufacturers turn to medical device consulting when in-house expertise is limited or when a one-off need (e.g. a first 510(k), a Pre-Sub, or an FDA response) justifies external support. Common drivers:
- Regulatory complexity — FDA’s requirements differ by device class and submission type. Missteps can lead to RTA, delays, or unnecessary testing. Consultants help you choose the right path and avoid costly rework.
- Quality system gaps — FDA expects compliance with 21 CFR Part 820 (Quality System Regulation) and, for many markets, ISO 13485. Consultants support gap assessments, procedures, and audit readiness.
- Resource constraints — Hiring full-time regulatory staff may not be feasible. Consultants provide targeted support for submissions, Pre-Subs, or remediation.
- First-time submissions or new product types — Experience with similar devices and submission types reduces risk and can shorten review cycles.
Source: FDA Premarket Submissions; 21 CFR Part 820 (Quality System Regulation).
What medical device consultants do
Medical device consulting services are usually scoped by project or retainer. Typical activities include:
- Regulatory strategy and pathway selection — Determining whether your device is 510(k), De Novo, or PMA, and outlining evidence and timeline. This often references FDA guidance and product codes.
- Premarket submission support — Preparing or authoring 510(k), De Novo, or PMA content; predicate research; substantial equivalence rationale; and assembly of eSTAR or other formats per FDA expectations.
- Pre-Submission (Q-Sub) support — The FDA Pre-Submission Program allows sponsors to get feedback before filing. Consultants help draft questions, prepare meeting materials, and interpret FDA’s responses.
- RTA and AI response — After a Refuse-to-Accept or Additional Information letter, consultants help address deficiencies and resubmit.
- Quality system and risk management — Supporting QMS design or remediation (e.g. 21 CFR 820, ISO 13485), risk management (e.g. ISO 14971), and readiness for FDA or notified body audits.
Deliverables vary: strategy memos, submission sections, gap assessments, SOPs, or ongoing advisory. A good consultant will align scope with your device type and regulatory pathway.
See FDA 510(k), De Novo, and Device Guidance Documents.
Standards and regulations medical device consultants work with
Medical device consulting is grounded in FDA regulations and, for many clients, international standards. Key references consultants use include:
- 21 CFR Part 820 (Quality System Regulation) — FDA’s requirements for design, production, and distribution of medical devices. eCFR Part 820.
- ISO 13485 — Medical devices — Quality management systems. Widely used for QMS and often expected by global regulators and notified bodies. ISO 13485:2016.
- ISO 14971 — Medical devices — Application of risk management to medical devices. Core for risk analysis and risk control. ISO 14971:2019.
- FDA guidance documents — Dozens of guidances cover specific device types, submission content, and processes. Consultants stay current with relevant guidances for your product. FDA Device Guidance.
When evaluating a medical device consultant, ask which of these they routinely use and how they apply them to your device class and submission type.
What to prepare before your first consultant call
Having a few things ready helps you get useful quotes and use the call well:
- Device description and intended use — A short summary of what the device does, who it’s for, and how it’s used. If you have a draft Indications for Use, bring it.
- Regulatory question or goal — e.g. “We need a pathway decision,” “We need a full 510(k) authored,” “We got an RTA and need help responding,” or “We need a QMS gap assessment.”
- Timeline — When you need to submit (or respond to FDA) and any internal milestones.
- Budget range (if you have one) — Even a rough range (e.g. strategy-only vs full authoring) helps the consultant propose a realistic scope.
You don’t need a full technical file. Enough context for the consultant to assess pathway and scope is sufficient.
Typical deliverables and how to scope the engagement
Medical device consulting is often sold as strategy-only, drafting support, or full authoring. Be explicit about what you’re buying:
- Strategy or pathway memo — Classification, 510(k) vs De Novo vs PMA, predicate options, evidence gaps, and high-level timeline. Usually a fixed deliverable.
- Pre-Sub support — Drafting questions, preparing the package, and (sometimes) attending the meeting. Often scoped per meeting.
- Submission authoring — Who drafts which sections (e.g. eSTAR), how many revision rounds, and who handles FDA correspondence. Define “done” up front.
- QMS or risk — Gap assessment, procedures, or remediation support. Scope by deliverable (e.g. gap report, SOP set) or by phase.
Get scope and deliverables in writing before you sign. For a step-by-step approach to scoping and avoiding scope creep, see How to scope a 510(k) consultant project. For pricing models (hourly vs fixed, what to compare), see 510(k) consultant pricing models.
Red flags when hiring a medical device consultant
Watch for the following; they often lead to poor fit or disputes:
- Vague on device type and pathway — Can’t name product codes or similar devices they’ve worked on, or gives only generic “regulatory experience.”
- Unwilling to put scope and deliverables in writing — “We’ll figure it out as we go” without a clear SOW or statement of work.
- Promising specific FDA outcomes — e.g. “We guarantee clearance by X date.” Consultants can’t guarantee FDA decisions.
- No clear plan for who does what — Who drafts, who reviews, who submits, who responds to FDA. Clarify roles and ownership of documents.
- No recent examples — No 510(k)s, Pre-Subs, or QMS work in the last few years in your device space.
For a longer list and how to probe for these in conversations, see 7 red flags when hiring a 510(k) consultant.
Questions to ask in a first call
Use the first call to assess fit and clarify scope. Helpful questions:
- Have you worked on devices like ours (similar product code, software level, or clinical claim)? Can you share anonymized examples or outcomes?
- What exactly would you deliver for this engagement (strategy memo, draft sections, full eSTAR, Pre-Sub package)? How many revision rounds?
- Who would do the work—named person or “the team”? Who interacts with FDA if we do a Pre-Sub or get an AI request?
- How do you charge for this type of project (hourly, fixed fee, phased)? What’s typically in scope vs out of scope?
- What do you need from us (inputs, reviews, meetings) and by when, so the timeline holds?
Comparing answers across two or three consultants will clarify both fit and realistic pricing.
How to choose the right medical device consultant
Fit and experience matter more than location. Practical steps:
- Match the pathway and device type — Ensure they have done work for your submission type (510(k), De Novo, PMA) and, where relevant, similar devices (e.g. software, sterilization, clinical data).
- Ask for examples and outcomes — Request anonymized examples: similar devices, Pre-Sub feedback, or submission outcomes.
- Clarify deliverables and process — What will you receive (strategy memo, draft sections, full authoring)? How many review cycles? Who interacts with FDA?
- Confirm quality and risk experience — If you need QMS or risk support, confirm experience with 21 CFR 820, ISO 13485, and ISO 14971.
Compare medical device consultants and request quotes:
510(k) submission services directory · FDA 510(k) consultants · ISO 13485 consultants · ISO 14971 consultants · FDA mock audit consultants
Compare medical device consultants
Compare profiles below and request quotes. Specify your device type and need (e.g. strategy, full 510(k), Pre-Sub, RTA response) so consultants can scope accurately.
FAQ
What should I have ready before my first consultant call?
Bring a short device description and intended use, your regulatory goal (pathway decision, full 510(k), RTA response, QMS gap, etc.), timeline, and a rough budget if you have one. You don’t need a full technical file—enough context for the consultant to assess scope is sufficient. See What to prepare before your first consultant call above.
How much does medical device consulting cost?
Pricing varies by scope (strategy-only vs full authoring), device complexity, and consultant experience. Many consultants bill hourly ($150–$300+ for solo experts) or by project; fixed fees for strategy or full 510(k) support are common. Request multiple quotes for the same scope and compare deliverables and revision rounds. See 510(k) consultant pricing models for typical structures.
When should I hire a medical device consultant?
Hire early when you need regulatory strategy (510(k) vs De Novo vs PMA), before Pre-Sub meetings, when building your QMS (ISO 13485), or when responding to FDA feedback (RTA, Additional Information). Early support can reduce rework and delays. FDA’s Pre-Submission Program is one example where consultant input before filing can clarify expectations.
What are red flags when hiring a medical device consultant?
Watch for: vague answers on device type and product codes, no recent examples in your space, unwillingness to put scope and deliverables in writing, promises of specific FDA outcomes (e.g. “guarantee clearance by X”), and no clear plan for who drafts what and who talks to FDA. See Red flags when hiring and 7 red flags when hiring a 510(k) consultant for more.
How do I scope the engagement and avoid scope creep?
Define deliverables up front (strategy memo, draft sections, full eSTAR, Pre-Sub package), revision rounds, and who handles FDA correspondence. Get it in a statement of work or contract. For a step-by-step guide, see How to scope a 510(k) consultant project.
Where can I verify FDA and ISO requirements?
FDA publishes regulations (e.g. 21 CFR Part 820), guidance documents, and submission information on fda.gov. ISO standards (e.g. ISO 13485, ISO 14971) are available from ISO. We list key sources in Sources and references on this page.
Sources and references
This page cites official FDA and ISO sources so you can verify the regulatory context. All links were current at the time of publication.
- FDA. Device Registration and Listing. fda.gov/medical-devices/device-registration-and-listing
- FDA. Premarket Submissions. fda.gov/medical-devices/premarket-submissions
- FDA. Pre-Submission (Pre-Sub) Program. fda.gov/medical-devices/premarket-submissions/pre-sub-program
- FDA. Premarket Notification 510(k). fda.gov/medical-devices/premarket-submissions/premarket-notification-510k
- FDA. De Novo Classification Request. fda.gov/medical-devices/premarket-submissions/de-novo-classification-request
- FDA. Device Guidance Documents. fda.gov/medical-devices/device-guidance-documents
- eCFR. Title 21 Part 820 — Quality System Regulation. ecfr.gov/current/title-21/.../part-820
- ISO 13485:2016. Medical devices — Quality management systems. iso.org/standard/59752.html
- ISO 14971:2019. Medical devices — Application of risk management. iso.org/standard/72704.html
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