Every time your medtech company posts on LinkedIn, X, or Instagram without a compliance review, you're risking warning letters, product seizures, and consent decrees. IronPost Media makes every post audit-ready before it goes live.
Built by John Duquette — 20+ years leading sales, marketing, and regulatory operations inside medical device companies including Boston Medical Products, Hayek Medical, and Vapotherm.
Posting a device benefit without proportional risk disclosure violates 21 CFR 801 and the FD&C Act. A single LinkedIn post claiming "improved outcomes" without ISI linking is a citable offense.
A hashtag, a reply to a comment, a repost of a clinician's testimonial — any of these can constitute off-label promotion if the content implies use beyond your cleared indications. The FDA doesn't distinguish between intent and impact.
When the FDA requests your promotional material archive, "we posted it on Instagram" isn't a compliance response. Every piece of social content needs timestamped archival, approval chain documentation, and version history.
Character limits on X force compressed disclosures. Instagram's visual format obscures required safety information. LinkedIn's reshare mechanics spread your content without your compliance controls. Each platform is a different compliance challenge.
IronPost Media doesn't bolt compliance onto your social media after the fact. Every piece of content is created within a regulatory framework from the start.
Every benefit claim is matched with proportional risk disclosure. ISI linking on every promotional post. All claims verified against 510(k) summaries and approved labeling.
Content is locked to cleared indications before a single word is written. Hashtags screened, UGC protocols enforced, audience targeting restricted to approved populations.
Every post archived with timestamped screenshots, approval chain documentation, version history, and adverse event response logs. Exportable for FDA inspection.
We start with your 510(k) summary, cleared indications, and IFU. This defines the compliance boundary — what we can and cannot say. No content is created before this step is complete.
Every post is written within the regulatory boundary. Fair balance is built in from the first draft — not bolted on during review. Platform-specific formatting ensures compliance works on LinkedIn, X, and Instagram.
Content moves through a documented approval chain: draft, regulatory review, medical/legal review, and final sign-off. Every stage is timestamped and archived. You see exactly what's going live and why it's compliant.
Posts go live with full compliance documentation. Timestamped screenshots, approval chains, and version history are archived automatically. If the FDA comes knocking, your social media archive is ready.
FDA regulations don't change by platform, but the compliance risks do. We format regulatory requirements to fit each platform without compromising substance.
Long-form format allows inline fair balance, but reshares and comments can spread your content without ISI links. We structure posts so compliance survives the share chain.
280 characters can't hold full safety information. We use link-in-bio strategies, thread structures, and compressed fair balance language that meets regulatory requirements within platform constraints.
Image-first content buries required disclosures. We use caption-based fair balance, story highlights for ISI, and visual design that makes safety information visible — not hidden in fine print.
IronPost Media isn't a marketing agency that read the FDA guidance documents. It's built by a medtech operator who's led regulatory compliance, product launches, and commercial operations from inside the companies that make the devices.
9+ years leading sales, marketing, and regulatory compliance for ENT and respiratory device lines.
Prepped for FDA audits, managed QMS implementation, and led 510(k) submissions as the person responsible — not an outside consultant.
From 510(k) clearance to market launch to post-market surveillance. Roles at Hayek Medical Devices and Vapotherm spanning the full device lifecycle.
If your company posts on social media and you sell FDA-regulated devices, you need a compliance-first approach to content. Here's who we work with.
You're scaling your social presence to support sales — but your regulatory team doesn't review social posts. One mistake from an eager marketing hire could trigger an FDA warning letter.
Your regulatory team is stretched thin managing submissions and audits. They don't have bandwidth to review every LinkedIn post and Instagram story. IronPost Media handles the social compliance load.
You just got 510(k) clearance and need to build market awareness fast. Speed matters — but so does compliance. We help you launch your social presence without regulatory risk.
Every post your medtech company publishes without regulatory review is a risk. IronPost Media builds compliance into your social media from the ground up — Fair Balance, off-label prevention, and audit-ready archiving in every piece of content.
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