Launch promo: Save 20% on the Medical Device Sustaining Project Starter Kit — code: START20

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Born from the field, built on experience, and driven by results. 

RC MedPartners exists to bridge the gap between regulatory theory and real-world execution in the medical-device industry. Founded by a 20-year veteran of design assurance and quality leadership, we’ve lived every phase of the product lifecycle — from concept and development through post-market sustainment and global compliance. 

We’ve seen firsthand how teams struggle to balance innovation with regulation. Too often, compliance feels like a burden instead of a competitive advantage. RC MedPartners was created to change that. 

Our approach is grounded in field-tested strategies, hands-on expertise, and actionable tools that empower organizations to achieve and sustain compliance under ISO 13485, 21 CFR 820, and EU MDR. We don’t just interpret regulations — we translate them into operational excellence. 

Through live and on-demand training, expert consulting, and custom process frameworks with templates we equip MedTech professionals with the clarity, confidence, and capability to thrive in complex regulatory environments. Every resource we create, every session we lead, and every client we partner with reflects one guiding belief: Compliance should enable innovation — not slow it down. 

At RC MedPartners, we’re more than consultants. We’re partners in your mission to deliver safer, smarter, and compliant medical devices to patients worldwide.

Templates Store

Auditor‑ready documents mapped to ISO 13485, 21 CFR, and EU MDR. Preview before you buy.

Bundles & Starter Kits

Save 20–30% with curated packs for common workflows.

Best Value

Medical Device Sustaining Project Starter Kit

Everything you need to stand up a sustaining project quickly: RAA, Change Control, Kickoff Agenda, Risk Plan, Trace Matrix, CAPA, Internal Audit Checklist.

$499
Maps to ISO 13485, 21 CFR, EU MDR

ISO 14971 Risk Essentials Pack

Risk Management Plan, DFMEA, Hazard Analysis worksheet, Risk Matrix, Verification of risk control effectiveness template.

$299

Audit‑Ready QMS Pack

Internal audit checklist, CAPA 8D, Document control SOP outline, Management review deck.

$349

Trainings

Live cohorts, on‑demand courses, and private team workshops.

On‑Demand

ISO 13485 Masterclass

Procedures that actually work. Includes slides, checklists, and examples.

$799
Live Cohort

ISO 14971 Risk Management Deep‑Dive

Real‑world hazard analysis, risk controls, verification strategy, and files that pass audits.

$1,199

483/Warning Letter Remediation Playbook

From triage to sustained closure. Templates + coaching.

$999

About RC MedPartners

Founded by Richard Chirdo — 20+ years in medtech Operations, PMO, Research and Development, and Quality.

We build tools and trainings that pass audits and speed submissions. No fluff, just what works.

Contact and Booking

Square Appointments will be embedded here. For now, send us a note.

or email: richard.chirdo@rcmedpartners.com

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Standards mapping
What’s included

    14‑day practical‑fit guarantee. Single‑seat license unless otherwise specified.

    Total: $0

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