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Regulatory Consulting Services

Practical, expert-led regulatory support — from early classification decisions to market access and post-market compliance.

✓EU MDR, UKCA, FDA support ✓Startup-friendly, scalable approach ✓Clear deliverables — not open-ended consulting

What We Do

Regulatory Affairs. Done Properly.

Regvo supports medical device and SaMD companies across the full regulatory lifecycle — from early-stage strategy to market approval and post-market compliance.

We work with startups and scaling companies that need senior-level regulatory expertise without building a full in-house team.

Clear

We translate complex regulatory requirements into practical, actionable steps your team can execute.

Proportionate

Support aligned to your device class, risk level, and development stage — no unnecessary over-engineering.

Action-Oriented

Every engagement delivers clear outputs, decisions, and next steps — not just analysis.

Common Challenges

What we help with

Most companies we work with face similar challenges at different stages of development.

"We're not sure what class our device is"
"We don't know where to start with regulatory"
"We're building documentation but not sure if it's correct"
"We're worried about delays, rework, or failing audits"
"We need a clear plan but don't have in-house expertise"

If this sounds familiar — you're not alone. This is exactly where we help.

Project Packages

Fixed-Scope Engagements

Our services are structured to support different stages of your regulatory journey — from early clarity to full execution and long-term support.

Clear scope. Defined deliverables. No ambiguity.

Our packages are fixed-scope engagements with clearly defined deliverables. You know exactly what you get — and what happens next.

All engagements are clearly defined upfront — so you know exactly what to expect.

Package 01

Starter

Understand your regulatory starting point and what to do first — without wasting time or resources.

£4,000 – 5,000
Focused engagement with clearly defined deliverables
  • ✓ High-level review of your product, intended use, and current stage
  • ✓ Initial classification direction — what your device is likely to be
  • ✓ Your route to market — which regulatory path makes sense and why
  • ✓ Step-by-step plan — what needs to be done first, second, and next
  • ✓ Clear explanation of key regulatory requirements relevant to your product
  • ✓ Prioritised next steps for the next 30–90 days
  • ✓ Written summary with clear, actionable recommendations
  • ✓ 1x strategy call (45 min)
Outcome: You know exactly where you stand and what to do next — with no guesswork.

Scope and deliverables agreed upfront before project start.

MOST POPULAR
Package 02

Strategy

A comprehensive regulatory strategy for companies that need a clear, structured plan to move towards market approval.

£7,000 – 10,000
Focused engagement with clearly defined deliverables
  • ✓ Device classification (EU, UK, or other agreed market)
  • ✓ Regulatory pathway selection with clear rationale
  • ✓ Regulatory roadmap with key milestones and realistic timelines
  • ✓ Documentation requirements mapping — what needs to be created and when
  • ✓ Identification of critical risks and regulatory considerations
  • ✓ Written strategy report with clear recommendations
  • ✓ 2x strategy calls (kick-off + final review)

Scope and deliverables agreed upfront before project start.

Package 03

Documentation Support

Support in building your technical documentation — with clear structure, templates, and expert review.

£5,000 – 10,000
Focused engagement with clearly defined deliverables
  • ✓ Technical documentation structure and compilation plan
  • ✓ Templates and guidance aligned with EU MDR / UKCA requirements
  • ✓ Review and feedback on your draft documentation
  • ✓ Identification of gaps and improvement areas
  • ✓ Practical support to help your team build documentation correctly
  • ✓ 1x kick-off call + ongoing review support

Note: Creation of specialised documents (e.g. clinical evaluation) can be supported via trusted partners if required.

Package 04

Full Track

End-to-end regulatory support — from strategy through execution, submission, and beyond.

Individually quoted
Long-term engagement with defined scope and milestones
  • ✓ Full regulatory ownership and ongoing guidance
  • ✓ We guide you through each stage — from planning to submission
  • ✓ Ongoing technical documentation support and review
  • ✓ Support in interactions with Notified Bodies, MHRA, or FDA
  • ✓ Coordination with specialist partners (clinical, testing, etc.) if required
  • ✓ Regular check-ins and structured project progression
  • ✓ Continuous adaptation as your product and strategy evolve
Outcome: You are supported through the entire regulatory process — from idea to approval and beyond.

Designed for companies that need a long-term regulatory partner — not one-off support.

Not sure which package fits?

Each package supports a different stage of your regulatory journey:

  • Starter — understand where you are and what to do first
  • Strategy — build a clear regulatory plan
  • Documentation — structure and develop your technical documentation
  • Full Track — ongoing, end-to-end support

Book a free discovery call and we'll recommend the right starting point for your situation.

How It Works

From first conversation to results

1

Understand your situation

We review your product, stage, and goals to understand where you are and what you need.

2

Define the right approach

We identify the best regulatory route and what needs to be done — clearly and without jargon.

3

Build your plan

You get a clear, step-by-step plan tailored to your product, market, and timeline.

4

Support execution

We support you in building documentation and moving towards approval — at every stage.

Who We Help

What sets us apart

  • ✓
    Senior-level expertise
    Over 10 years of hands-on regulatory experience in medical devices.
  • ✓
    Practical, not theoretical
    Clear steps your team can actually execute.
  • ✓
    End-to-end support
    From early-stage decisions to submission and beyond.
  • ✓
    Flexible support model
    From one-off strategy to long-term partnership.
  • ✓
    Partner network
    Access to trusted specialists — clinical, testing, and more — when needed.

Who This Is For

Is this for you?

  • → MedTech startups at early development stage
  • → Companies preparing for EU MDR, UKCA, or FDA pathways
  • → Teams without in-house regulatory expertise
  • → Companies that need clear direction and structured support

Ongoing Support

Fractional RA Partner

Ongoing regulatory support for companies that need continuity, not ad-hoc consulting. We act as an extension of your team.

Essential

Essential

For early-stage startups that want a regulatory expert "on call" and to stay informed.

£1,800 – 2,000
per month · min. 3 months · 1-month notice period
  • ✓ Regulatory Q&A by email (response within 48h)
  • ✓ 1x monthly call (45 min) — status review or open questions
  • ✓ Regulatory updates relevant to your product
  • ✓ Review of one document per month
MOST POPULAR
Growth

Growth

For startups actively building documentation or preparing for certification.

£3,500 – 4,000
per month · min. 3 months · 1-month notice period
  • ✓ Priority access — email response within 24h
  • ✓ Up to 3x calls per month
  • ✓ Document review — up to 2 documents per month
  • ✓ Support in NB, FDA, or MHRA communications
  • ✓ Regulatory updates + proactive alerts
  • ✓ Subcontractor coordination if needed
Partner

Partner

For startups without an in-house RA function — Regvo acts as your external regulatory department.

£6,000 – 8,000
per month · min. 6 months · 1-month notice period
  • ✓ Full access to Regvo and partner network
  • ✓ Unlimited communication (priority, 24h response)
  • ✓ Unlimited calls (within reasonable scope)
  • ✓ Documentation review
  • ✓ Full support in authority interactions (NB, FDA, MHRA, other)
  • ✓ Regulatory project coordination and management
  • ✓ Specialist tasks covered via partner network (cybersecurity, clinical, etc.)
  • ✓ Quarterly strategic sessions

How subscriptions work with project packages: Subscriptions and large project packages can run in parallel — they cover different types of work. Typical flow: complete a project package (Starter → Strategy → Documentation), then transition to an ongoing subscription for continued support.

Large projects such as full Technical Files or QMS implementation are always scoped and priced separately, even for active subscribers.

Not sure what's the best fit for your company?

Book a free 30-minute discovery call.
We'll review your product, market, and regulatory goals — and find the right path forward for you.

Book a discovery call contact@regvo.co.uk