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ASSOCIATES
Medical Device & Combo Product Consulting
Sustained program work across structural heart, ENT, neurovascular and commercial products — multiple submissions, clearances and launches.
All case studies →[Client quote 1 — paste the testimonial here.]
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Most consultancies hand you a spreadsheet. We built the tool instead: rmForge drafts your ISO 14971 Hazard Analysis from your IFU and product requirements, ready for your team to review.
See rmForgeFifteen-minute call, no deck. Tell us where the program is and we will tell you plainly whether we are the right help.
Most engagements start with one of these and grow. We do the work rather than advise on it — the deliverable is a file that survives review, not a recommendation memo.
Design history files that hold up. Requirements, verification and validation, design reviews, transfer — plus the capital and production equipment the build depends on.
Learn more →ISO 14971 from hazard analysis through benefit-risk. Class III work aligned to IEC 62304, IEC 62443 and ISO/TS 10974 where software and MR safety apply.
Learn more →510(k), IDE and PMA strategy and authoring. Predicate analysis, testing plans, pre-submission meetings, and the deficiency responses that follow.
Learn more →QMS build-out from nothing, or remediation when the system stopped matching the work. FDA QSR, ISO 13485, EU MDR, CAPA and post-market surveillance.
Learn more →Transfer to production, process validation, fixture and equipment specification, supplier qualification and the sustaining work after launch.
Learn more →Mechanical and electrical design, working prototypes, test fixtures and production equipment — designed, built and qualified in-house.
Learn more →Purpose-built applications for medtech teams — device software, internal tools, data pipelines and the QMS-adjacent systems nobody sells off the shelf.
Learn more →VP R&D, VP Quality or program lead on a fraction of a headcount. Board-ready reporting, team leadership, and someone accountable for the date.
Learn more →Medical electrical equipment designed and documented to IEC 60601-1, the -1-2, -1-6 and -1-11 collaterals, and IEC 60601-2-34 for invasive blood pressure monitoring.
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Documents, not slideware. Everything below lands in your QMS under your own numbering, ready for review.
Most of our engagements sit under NDA. These are anonymized to the level each client has approved — happy to talk through specifics under our own NDA on a call.
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Thirty years in medical device product realization, across startups raising their first round and manufacturers shipping at scale. The through-line is the same: turning an idea into a device that clears review and can actually be built.
Seventy-five issued patents, fifteen-plus 510(k) submissions, and work spanning eleven therapeutic areas — structural heart and valves, cardiovascular, peripheral and neurovascular, renal, spinal, orthopedic, ENT, sleep apnea and combination products.
Hands-on with medical electrical equipment to IEC 60601-1, the -1-2 EMC, -1-6 usability and -1-11 home-use collaterals, and IEC 60601-2-34 for invasive blood pressure monitoring.
Twenty-five years of medical device operations, quality and regulatory leadership — including ten years at Stryker and director and VP roles across five countries in North America and Europe.
RAC certified and a certified lead auditor since 2006, with seven years of QMS implementation and audit consulting. BA from the University of Michigan, MBA from Norwich University, and ten years on active duty in the U.S. Army.
Founded by David G. Reo, Pinecrest AI covers agentic system design, LLM pipeline architecture and model selection. Pinecrest is the engineering behind rmForge and the custom applications we deliver for clients.
AI-drafted ISO 14971 hazard analysis, built by the same people who write these files by hand. Mike is CEO and founder; Drew leads regulatory and quality.
Our work with Aledyne is led by Steffan Benamou.
Not a gap assessment telling your team what to write. The deliverable is the controlled document, in your QMS, under your numbering.
Transfer, process validation, supplier qualification and sustaining. Clearance is the middle of the job, not the end of it.
rmForge came out of doing hazard analysis by hand too many times. Clients get the benefit of software built by people who use it on real submissions.
κυριος ιησους χριστος
rmForge drafts an ISO 14971:2019 Hazard Analysis from your Instructions for Use and product requirements — traceable to your User Needs, review-ready, and delivered as a 26-column workbook.
Teams fill an empty workbook live, line by line, in sessions that pull the whole team off device work. Vocabulary and logic drift from project to project.
Sign up and book a session. We run your device through the wizard on a screen share and review the drafted rows together — hazards, harms, severity and probability.
One controlled vocabulary and one rule set write every row, checked against ISO 14971 and ISO/TR 24971. Revise later and you get a redlined workbook with a change summary.
Written for the engineer or quality lead who has to produce the document, not for a search engine.
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AI skills, white papers, literature reviews and SOP templates from our own work. Free to use. If one saves you a week, we would like to hear about it.
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Nothing here yet. The first downloads are on their way.
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Works in Claude, ChatGPT, Codex, Gemini and any tool that reads the open Agent Skills format. In Grok, DeepSeek and other chat tools, paste the SKILL.md text in as your instructions.
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A few details and your signature, then your download is ready.
Typing your name is your electronic signature. We use these details to send the file and, now and then, related material from MLR Associates. We do not sell or rent your information. Unsubscribe any time. See our Privacy Policy.
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Fifteen minutes, no deck, no discovery process. Tell us where the program is and we will tell you plainly whether we are the right help — and if we are not, who is.
Goes straight to Mike. No sequence, no CRM nurture, no newsletter signup.
Edit any copy on the site, tune the palette, save the result as a named configuration, and rotate configurations on a schedule. Everything is stored in this browser — nothing is published until you tell me to bake it in.
The words beside the MLR mark. The wordmark changes in the header and footer; the tagline sits under it in the header and is also used as the slogan in search results.
Every callout on the animated figure, in the order it lights up. Each one also appears as a cell in the therapeutic-areas grid on Home. Change the name or note, pick which part of the body glows, reorder, delete, or add new ones.
Switch a page off and it disappears from the site along with every link pointing to it — header, footer, buttons and cards. Its copy is kept, and you can still edit it from here while it is off.
Hide any section of any page. Its copy is kept; switch it back on and it returns exactly as it was.
Pick a page and a drawer opens alongside it listing every piece of text on that page. Edits apply live and persist in this browser.
One file holding every copy edit, every article, the saved palette configurations and the rotation schedule. Download it as a backup, hand it to a colleague, or paste it into chat and I will bake the lot into the source.
Paste a downloaded file here to load it into this browser — use this to move your work to another machine, hand a review copy to a colleague, or undo a browser reset. It replaces what is currently stored.
A readable was/now list rather than a data file — handy when you only want to discuss the wording. The full backup above is the one to send if you want the edits baked in.
Every colour below is a design token the whole site reads from, so a change here moves every page at once.
Save the current settings under a name. Saved configurations can be applied any time, or rotated on a schedule.
Pick an article to edit, or start a new one. Published articles appear on the Insights page in this order.
Each article gets a title, meta description, canonical URL, Open Graph and Twitter cards, and Article structured data. Those go into the page head as you browse — good enough for sharing previews and for Google, which renders JavaScript. For the strongest ranking, I should generate a real static HTML page per article when we build for Cloudflare Pages; tell me when you want that and it is a build step, not a rewrite.
Each one gets a card on the Work page and its own page at /work/your-slug. Mark one as featured to give it the large slot at the top.
Each one gets a card on the Downloads page and its own page at /downloads/your-slug, which is the link to share on LinkedIn. Drafts are only visible while the admin is unlocked. Every download asks for name, email and company first.
Everyone who requested a download: name, email, company, which download and when. On the live site each request is saved here and emailed to info@mlreoconsulting.com. In this preview the list only shows requests made in this browser.
The title, description and focus phrase for every page. These set what Google shows in results, what LinkedIn shows when a link is shared, and the structured data search engines read about the firm. Articles are set in the Insights tab.
Cycle saved configurations on a timer, or bind them to times of day. Rotation runs whenever the site is open in a browser.
Cycles through every saved configuration in order.
Click any text on the page to jump to its field.
The grid cells and the figure callouts. To add, delete, reorder or change which part of the body lights up, use Admin → Content → Figure callouts.
Use “+ Add field” at the bottom of any section on the page. Added fields appear at the end of that section.