Built for medical device
Marketing & Marcomms teams

Send Regulatory a cleaner first draft, every time.

Pre-check your medical device copy for non-compliant claims before they cost you multiple rounds of review.

Fewer rewrites. Faster approvals. Less stress. Campaigns that ship on time.

Built for medical devices, not pharma
Potentially save hours on every asset
Fewer rounds, faster approvals
Helps you launch on time, on budget
Claim risks we identify
Overstated safety
Unapproved indications
Absolute language
Unsupported superiority
Implied endorsement
Off-label use
Missing evidence
Comparative claims
Patient outcomes
Overstated safety
Unapproved indications
Absolute language
Unsupported superiority
Implied endorsement
Off-label use
Missing evidence
Comparative claims
Patient outcomes

Today, every round of review costs your team valuable time they do not have.

One piece of content can bounce between Marketing, Marcomms, Regulatory and Design for weeks.
Pre-check it before Regulatory even sees it to save time and a whole load of stress.

Today's MLR copy approval flow: Marketing drafts copy, Marcomms shapes it, Regulatory and Legal review for compliance, with re-checks back to Marketing and issues bouncing to Design.
THE REAL COST OF YOUR MLR COPY APPROVAL PROCESS

What MLR loops actually cost you.

Marcomms burn out

Rewriting the same line for the fifth time is how great employees quietly start job hunting.

Launch dates slip

Every MLR round pushes the campaign closer to the deadline that won't move. Stress that everybody can do without.

Regulatory becomes the bottleneck (and the villain)

They're doing their job and it's an important one. But they become the team everyone blames for the slip.

Where MLR PreCheck fits into your process.
Helps save multiple rounds of review.

Marketing and Marcomms can now run a quick pre-check before sending for review.
Regulatory always have the final say, but they now get a more compliant draft.

Using MLR PreCheck between each handover means fewer surprises downstream, fewer loops, and fewer late night rebuilds for Design.

See it in action

MLRPreCheck.com walkthrough

A short tour of how MLRPreCheck.com pre-reviews your marketing copy for non-compliant content before you send it to Regulatory, saving you multiple rounds of review.

Built on real guidance

Grounded in the latest rulebook for every market we cover.

Every check runs against the latest medical device legislation and advertising codes for the regions you select, and tells you which clause each finding maps to.

No generic AI guesswork.

US
FDA / FTC
EU
MDR / IVDR
UK
MHRA / UK MDR
Canada
Health Canada
Always current
MLR PreCheck

Representative selection of key legislation and advertising codes we check against:

FDA + FTC

United States

  • FDA 21 CFR Part 801 (labelling)
  • FDA 21 CFR Part 807 (510(k) / cleared vs approved)
  • FTC Act Section 5 - substantiation, endorsements, testimonials
  • FDA Guidance: Presenting Risk Information in Prescription Drug and Medical Device Promotion
MHRA + ASA

United Kingdom

  • UK Medical Devices Regulations 2002 (as amended)
  • MHRA guidance on device advertising and UKCA / CE marking
  • CAP Code Section 12 enforced by the ASA
  • ABHI Code of Business Practice
EU MDR + IVDR

European Union

  • EU MDR Article 7 (Regulation (EU) 2017/745) - claims
  • EU IVDR (Regulation (EU) 2017/746)
  • MedTech Europe Code of Ethical Business Practice
  • Unfair Commercial Practices Directive (2005/29/EC)
Health Canada

Canada

  • Food and Drugs Act
  • Medical Devices Regulations (SOR/98-282)
  • Competition Act + Ad Standards Canada Code
  • Health Canada Guidance on Advertising of Medical Devices

Rules in. Citations out. Updated as the guidance moves.

Who it's for

Made for medical device teams. Not for pharma.

Who it's for
  • In-house Marketing & Marcomms teams at medical device manufacturers
  • Class I, II and III devices, plus IVDs
  • Agencies writing copy on behalf of medtech clients
  • Teams launching across US, UK, EU and Canada
Who it's not for
  • Pharmaceutical promotional copy (ABPI, PhRMA, EFPIA codes)
  • Cosmetics, supplements or general wellness brands
  • Veterinary medicines or animal health products
  • Any use case outside medical-device advertising

Confidential, by default.

Every company gets its own private workspace. Your copy, your documents and your drafts stay siloed inside it, locked away from everyone else, and nothing you put in is ever used to train AI models.

Ready to cut review rounds?

Send Regulatory a tighter first draft. Run your first check in minutes.

Less than 2 minutes to your first check