A dedicated monthly intelligence service that monitors FDA, EU MDR, and UK MDR developments, identifies changes that affect your compliance posture, and delivers a structured briefing report — filtered precisely to your device classification and target markets. So nothing catches you by surprise.
First briefing delivered within 2 weeks of onboarding.
Each change potentially affects your technical file, your clinical evaluation strategy, your PMS obligations, or your labelling compliance. A manufacturer who learns about a guidance change six months after it was published is already behind.
This is not a generic newsletter. Every briefing is filtered to your device classification, your target markets, and your current compliance stage.
Every retainer engagement produces the same structured set of deliverables each month — filtered to your device classification and target markets, delivered to your inbox on a fixed schedule.
Direct email access to raise regulatory questions as they arise. Up to four substantive advisory questions per month — answered with specific regulatory references, not generic guidance. Response within two business days.
Up to 4 questions/monthAll monthly briefing reports retained and accessible throughout the engagement. Cumulative regulatory intelligence — so when a submission or audit requires you to demonstrate awareness of regulatory developments, your complete monitoring record is available.
Ongoing · full archiveEvery briefing has two layers: technical detail for your QA team with specific article references, and a plain-English summary for management.
The gap identification section is what makes the difference. Most regulatory newsletters tell you what changed. We tell you what it means for your documentation — and whether you need to act.
Priced by device classification and number of markets monitored. Class IIb active pricing reflects the additional IEC 60601 standards monitoring load and more complex regulatory landscape.
A quality director at a mid-size Asian manufacturer has three realistic options for regulatory monitoring. Here is an honest comparison.
| Factor | Full-Time RA Director | Large Consultancy | VerityNodes Retainer |
|---|---|---|---|
| Monthly cost | $6,000–$12,000+ salary | $8,000–$20,000+ retainer | $2,500–$5,500 |
| Setup / hiring time | 3–6 months | 2–4 weeks | First briefing in 2 weeks |
| Three-market coverage | Depends on hire | Additional fee per market | Included in one engagement |
| IEC 60601 standards tracking | Depends on expertise | Specialist billed separately | Included for Class IIb |
| Manufacturing floor experience | Rare in RA hires | Typically academic / regulatory | 25 years — core to the service |
| Device-filtered intelligence | Generic monitoring | At additional cost | Classification-filtered by default |
| Minimum commitment | Employment contract | Typically 6–12 months | 3 months only |
| Exit flexibility | Notice period + severance | Contract penalties | 30 days notice after month 3 |
Onboarding is straightforward. We need to understand your device classification, your target markets, and your current compliance stage — then we can configure the intelligence filters and begin monitoring. There is no lengthy intake process.
30-minute call to understand your device classification, target markets, current documentation position, and specific monitoring priorities.
Free · no obligationWe confirm the retainer tier, markets to be monitored, classification filters, and delivery schedule. Engagement letter issued and signed.
Day 1–2We review your current compliance baseline, configure the regulatory monitoring filters, and set the briefing schedule. For new clients without a prior audit, a brief onboarding baseline assessment is included.
Day 3–7Your first monthly regulatory briefing report arrives — filtered to your classification and markets, with gap identification and recommended actions where applicable. Monthly delivery continues from this point.
Within 14 days of onboardingComplete the form. We respond within one business day to confirm your tier and schedule onboarding. First briefing within two weeks of signing.
VerityNodes Ltd · [email protected] · Registered in England and Wales.
· Privacy · Terms Regulatory intelligence & drafting support — not regulated legal or regulatory affairs advice.