Medical Device Regulatory Consulting & Documentation

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

✓ Audit-Ready Templates ✓ ISO 13485 · EU MDR · FDA QMSR ✓ 10+ Markets Covered ✓ Instant Download · Fully Editable
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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, IEC 62304 and MDSAP — instantly downloadable, fully editable.

✦ 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, 22 templates, in one premium bundle.
✓ Pre-market & post-market · ✓ Save €178
€999 Explore Bundle
✦ Premium Bundle · Global QMS

Combined Kit ISO 13485 + MDSAP

The global QMS bundle — every ISO 13485 process plus all 5 MDSAP markets in one premium package for manufacturers selling worldwide.
✓ Word & Excel · ✓ Save €199
€699 Explore Bundle
✦ Premium Bundle · Software + AI

SW Documentation Kit Gold

23 templates in three coordinated modules: the full IEC 62304 lifecycle, cybersecurity, and the complete AI/ML module. Built for AI-enabled software and SaMD.
✓ IEC 62304 + Cyber + AI/ML · ✓ Save €199
€799 Explore Bundle
✦ 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 Bundle
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
✦ EU MDR

EU MDR Technical Documentation Kit

The full Annex II technical file in one coordinated set. 8 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

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 · Software

IEC 62304 SW Documentation Kit

The complete software lifecycle file for medical device software and SaMD — development plan to release record, plus the cybersecurity documentation Notified Bodies now expect.
✓ 12 templates · ✓ IEC 62304 · 82304-1 · MDCG 2019-16
€499 Explore Kit
✦ 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
✦ 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
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Need individual documents?

Browse our library of individual SOPs and templates — buy only what you need, starting from €69.

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