Regulatory intelligence for medical device & software professionals

Know the moment it matters.

The FDA, CISA, IMDRF and EU MDR are where we start. GrapeBeaver reads them alongside dozens of other regulators, standards bodies, notified bodies and manufacturer advisories every day, and tells you what impacts your organization, your products, and the policies, standards and operating guidance you have already written — alongside the events shaping the industry you work in.

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Every day, hundreds of new items are published that could affect medical device cybersecurity: FDA guidance and notices, EU and international regulations, standards updates, vulnerability advisories, enforcement actions.

If you're responsible for product security or regulatory compliance, keeping up with all of it is your job.

So first, you sift through everything to find what's relevant to you. That's hours, every week.

Then you work out what it actually means. Which products are affected. Which teams need to know. Which processes need to change. That's the analysis most people never have time to do.

GrapeBeaver does that work for you. It gathers intelligence from over a hundred sources, and counting, and filters it against your portfolio. Then it delivers a briefing that tells you what changed, why it matters to you, and what you may be asked about.

Less time searching. More time acting.

GrapeBeaver Intelligence. Know what matters.

Every item, scored, sourced — and answered once

One row per advisory, with everything it impacts and why: the products you ship, the obligations it changes for your organization, the policies, standards and operating guidance it bears on, and the industry events it belongs to. Answered once, by your team, in one place. Severity is the only thing on the page allowed to be loud — so when something is red, it means something.

grapebeaver.io/app/impact · News feed
Low · 5 EC New Medical Device Regulations · 29 Oct 2026
Expert decision and opinion (CECP-EMA/EX/0000326614) - General and plastic surgery and dentistry

The European Commission has published an expert decision and opinion (reference CECP-EMA/EX/0000326614) concerning general and plastic surgery and dentistry, issued under the Medical Device Coordination Group's Clinical Evaluation …

Dental devices and systems
Low · 5 MHRA — guidance and publications · 30 Oct 2026
MHRA approves gene-editing treatment for children aged five and over with serious inherited blo…

The MHRA granted an extension to the UK marketing authorisation for Casgevy (exagamglogene autotemcel), a gene-editing treatment for severe sickle-cell disease and transfusion-dependent β-thalassemia, on 29 October 2026. …

Regulatory guidanceLaboratory automation and LIS
Low · 5 FDA CDRH · 30 Oct 2026 watch-d99650b385154996
CDRH New - News and Updates

FDA's Center for Devices and Radiological Health has announced a public meeting of the Microbiology Devices Panel of the Medical Devices Advisory Committee, to be held November 19, …

In-vitro diagnostics
Low Team-NB — notified body position papers · 29 Oct 2026
Team-NB with TEAM PRRC 2026 in Prague

This item is published under a title referencing Team-NB's TEAM PRRC 2026 event in Prague, but the content retrieved consists entirely of Team-NB's website privacy and cookie policy …

Privacy and data protectionRegulatory guidanceLaboratory automation and LIS

A match is not a claim that your product is affected. When an advisory names something you ship — by component, package, or vendor and product — the feed says so. When it does not, and we have matched on the kind of device or the kind of exposure, it says that instead: worth checking, not something you are affected by. Most advisories are about somebody else's device, and saying so plainly is the point.

127
Sources watched continuously
41
Device categories in the taxonomy
100%
Items read by a person before you see them

One page: what is open, what to do, what is coming

Written once a day and read by your whole team: what may bear on your organization, what reached your products and your policies, standards and operating guidance and is still open, the dated obligations arriving in the next fortnight, and the events shaping the industry around them. Not a dashboard of counters — counters are how you check a feeling you already have.

grapebeaver.io/app · example
RIGHT NOW · FOR NORTHLAKE MEDICAL
Third-party component provenance is where the pressure is this week, and three of your four products ship components you do not maintain.

Two advisories reached InfusionSuite Gateway; the FDA's updated premarket expectations name support-level information in the SBOM, which is the part your current submission pack does not carry.

WHAT YOU ARE EXPOSED TO
Third-party component provenance 2 new · 4 open
because InfusionSuite Gateway and VitalView M400 — contains open-source components
Exposure on the clinical network 1 new · due 14 Sep
because InfusionSuite Gateway — connected to the clinical network
Premarket cybersecurity evidence nothing moved
watched, and worth saying it was quiet
COMING UP · NEXT 14 DAYS
14 Sep — comment period closes on the draft premarket guidance
11 Dec 2027 — Cyber Resilience Act applies, and it applies to you

Illustrative. The exposure board is derived from the products you register — no similarity score, nothing you cannot check and disagree with.

Your SBOM says what is inside. It does not say what is still supported.

A component does not have to be vulnerable to be a problem. It just has to stop being maintained — no CVE, no advisory, no notification. Regulators increasingly expect a manufacturer to know the support status of what they ship and to have a plan for when it ends, and that is not something a scanner tells you.

  • Every component in every SBOM you upload is resolved against published end-of-life dates, release history and repository activity.
  • A support status for every component, with the date behind it: still supported, end of life stated for a date, out of support, or no release in three years. The answer a reviewer, an auditor and a 524B submission all ask for.
  • Sourced and dated, so it goes straight into your documentation. Each status names where it came from — the publisher's own end-of-life notice, the release history, the repository — and when it was checked.
  • This is the number teams currently chase by hand across a dozen vendor pages, and the one regulators increasingly expect you to have an answer for.
grapebeaver.io/app/portfolio/lifecycle · example
openssl 3.0.8
InfusionSuite Gateway · End of life stated by the publisher, 7 Sep 2026
linux-kernel 5.10.180
VitalView M400 · Version series out of support
dcmparse 3.9.1
VitalView M400 · No release in 3 years
mosquitto 2.0.15
InfusionSuite Gateway · Supported
4 of 61 components need a look · 12 not identifiable upstream

Gathered, assessed, reviewed, sent

01 · GATHER

Every source, one feed

Regulators, standards bodies, sector coordinating councils and manufacturer PSIRTs — the FDA, CISA, the UK MHRA, EU MDR/IVDR, Health Canada and IMDRF among them, alongside the industry and trade publishers that carry what the regulators have not said yet. Finding the rest is a standing job rather than a finished list: we keep hunting for publishers worth watching, check each one before it goes in, and add it for everybody. Everything is normalised and deduplicated as it arrives, so a cross-posted advisory reaches you once. Vulnerability feeds (NVD, CISA KEV) are read as evidence for what is in your SBOM, not forwarded to you one CVE at a time; your scanner already does that better.

02 · ASSESS

Scored on what it means for patients

Every item is summarised once and scored 0–100 on how exploitable it is against what happens clinically if it is — because a flaw in a firewall appliance and the same flaw in an infusion pump are not the same finding. The reasoning is on the page with the score, so you can check it against the source and disagree where you should.

03 · REVIEW

A person signs off

Nothing reaches your inbox until someone has read the assessment against the source and approved it. That gate is not optional, and it is why a summary here means something. GrapeBeaver is built and run by product security professionals for product security professionals — the reviewer knows what a 524B submission needs, and reads it that way.

Digests that respect your inbox

Daily or weekly, at a time you choose. It leads with a one-line count, groups by severity with the most serious first, and links each item back to the full assessment.

  • It arrives on your cadence even on a quiet week — carrying what is still open and what is coming, so silence never has to mean "nothing happened" or "something broke".
  • Set a severity floor and never see below it.
  • Every digest is archived and searchable, so "that thing from three weeks ago" is findable without digging through mail.
  • No hero images. A compliance inbox is not the place for one.
See a full sample
GRAPEBEAVER DAILY DIGEST
3 new items, 1 at high or critical severity.
Low
Expert decision and opinion (CECP-EMA/EX/0000326614) - General …
EC New Medical Device Regulations · 29 Oct
Low
MHRA approves gene-editing treatment for children aged five and…
MHRA — guidance and publications · 30 Oct
Low
CDRH New - News and Updates
FDA CDRH · 30 Oct

One plan. Free to try.

Start with a free 14-day trial — no card required, every feature included. After that it is $29 a month for one person, with your SBOM read, your documents assessed and every product matched, and a few dollars for each colleague. No seat minimum.

Free for 14 days — no card required. At the end we ask you to subscribe; if you do not, nothing is charged, the account becomes read-only, and it is deleted 90 days later.

GrapeBeaver Intelligence is operated by Matt Hillyer LLC, a Wisconsin limited liability company.

Try it free for 14 days

No card required. Every feature is included — register your products, upload an SBOM and your documents, and see what reaches you. When the trial ends you decide whether to subscribe; nothing is charged unless you do.

Start your free trial

14 days · no card · $29/month after, if you subscribe

Assessments are AI-assisted and human-reviewed

Every summary and severity score is produced by an analysis agent and then read, corrected where needed, and approved by a person before it is published. GrapeBeaver surfaces intelligence for you to act on — it does not replace your own regulatory judgment, and it makes no compliance guarantee.