Medical Device Regulatory Consulting & Documentation

Navigate Global Regulation with Confidence

Audit-ready documentation, expert consulting, and practical tools for medical device companies — ISO 13485, EU MDR, FDA QMSR, MDSAP and beyond.

✓ ISO 13485 Lead Auditor ✓ EU MDR & FDA QMSR Expert ✓ 15+ Years Experience ✓ 10+ Markets Covered
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How We Can Help

Three ways to work with MD Regulatory — choose what fits your needs.

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Audit-Ready Documentation

Instantly downloadable SOPs, procedures, templates and databases — built by a former Notified Body auditor. ISO 13485, EU MDR, FDA QMSR, MDSAP and more. Individual packages or complete bundles.

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Regulatory Consulting

Expert support for ISO 13485 implementation, EU MDR compliance, FDA QMSR, MDSAP, gap analysis, mock audits, and international registration. Remote or on-site, project-based or retainer.

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Self-Audit Tools

Free and premium interactive tools to assess your QMS readiness — Standards Finder, ISO 13485 Audit Checklist, EU MDR Gap Analysis and more. Built on real audit experience.

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Medical Device Compliance Kits

Audit-ready document packages aligned with ISO 13485, EU MDR, FDA QMSR and MDSAP — instantly downloadable, fully editable.

✦ Premium Bundle · QMS

Combined Kit ISO 13485 + MDSAP

The ultimate global QMS bundle — every ISO 13485 process plus all 5 MDSAP markets in one premium package for global manufacturers.
✓ Word & Excel  ·  ✓ Save €199
€699 Explore Kit
✦ Premium Bundle · EU MDR

MDR Complete Bundle

The complete EU MDR documentation set: technical file (Annex II), clinical evaluation and risk management. Three coordinated kits in one premium bundle.
✓ Pre-market & post-market  ·  ✓ Save €178
€999 Explore Kit
Standalone Kits
✦ Most Popular

ISO 13485 QMS Kit

Complete QMS documentation aligned with ISO 13485, EU MDR, FDA QMSR and MDSAP. SOPs, templates, Quality Manual and Master Tracker in one coordinated set.
✓ Word & Excel  ·  ✓ Audit-ready
€499 Explore Kit
✦ Multi-Market

MDSAP Documentation Kit

Single-audit documentation for 5 markets — Brazil, Japan, Canada, Australia and USA. SOPs and templates aligned with the MDSAP audit model.
✓ 5 jurisdictions  ·  ✓ MDSAP-aligned
€399 Explore Kit
✦ New · EU MDR

Technical Documentation Kit

The full Annex II technical file in one coordinated set. Word templates from Device Description to Declaration of Conformity, with Team-NB position papers integrated.
✓ Annex II + III + IV  ·  ✓ NB-ready
€429 Explore Kit
✦ EU MDR

Clinical Documentation Kit

Audit-ready clinical and post-market documentation for EU MDR. Word templates covering Clinical Evaluation, Post-Market Surveillance, PMCF and SSCP.
✓ MDCG-aligned  ·  ✓ NB-ready
€399 Explore Kit
✦ New · Risk Management

Risk Management Kit

Audit-ready risk file aligned with ISO 14971:2019, IEC 62366-1 and EU MDR. Word and Excel templates including active FMEAs and the GSPR Checklist.
✓ ISO 14971 aligned  ·  ✓ Active FMEAs
€349 Explore Kit
✦ New · AI/ML

AI/ML Medical Device Kit

The complete AI/ML technical documentation set — one coordinated package for five markets. 10 documents covering the full ML lifecycle with IMDRF GMLP as the convergent spine.
✓ FDA · EU AI Act · HC · TGA · ANVISA  ·  ✓ PCCP included
€499 Explore Kit
✦ Bundle · EU MDR

Risk + Clinical Bundle

Two coordinated kits for the pre-market and post-market clinical and risk file. Clinical Documentation Kit + Risk Management Kit in one bundle.
✓ Pre-market & PMS  ·  ✓ Save €149
€599 Explore Kit
Coming Soon
Coming Soon

Medical Software Documentation Kit

Complete documentation for medical device software (MDSW) and Software as a Medical Device (SaMD) — IEC 62304 lifecycle, FDA pre-market and cybersecurity.
✓ IEC 62304  ·  ✓ FDA SW guidance  ·  ✓ Cybersecurity
€499 Notify Me
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Need individual SOPs?

Browse our library of individual SOP packages — buy only what you need, starting from €69.

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