Complete Suite
All 15 toolkits in one package. Complete QMS coverage from design controls through post-market surveillance. 100+ professional templates.
- All 15 individual toolkits included
- 100+ professional templates
- Covers FDA, EU MDR, MDSAP, ISO 13485
- Design controls through post-market surveillance
one-time payment
Advanced Compliance Toolkits
For clinical studies, multi-country audits, and technical documentation
MDSAP Audit Prep
Complete MDSAP audit preparation toolkit covering all 5 participating countries. Mock audit checklis...
Clinical Evaluation (CER)
Complete clinical evaluation toolkit with CER templates, PMCF plans, biocompatibility assessment, an...
Clinical Investigation
Complete clinical investigation toolkit with IDE application templates, clinical protocol, informed ...
Environmental Monitoring
Environmental Monitoring and Cleanroom Qualification Toolkit: ISO 14644 Templates - complete templat...
Biocompatibility Strategy
Biocompatibility Testing Strategy Toolkit: ISO 10993-1:2018 Templates - complete templates for medic...
Sterile Packaging Validation
Packaging and Sterile Barrier System Validation Toolkit: ISO 11607 Templates - complete templates fo...
CER Literature Review
Clinical Evaluation Report (CER) and Literature Review Toolkit: EU MDR Templates - complete template...
EU MDR Technical Docs
EU MDR Technical Documentation Toolkit: Annex II + GSPR Templates - complete templates for EU MDR co...
FDA Warning Letter Response
FDA Warning Letter Response Toolkit — root cause analysis, CAPA plan, formal response letter templat...
FDA Pre-Submission Q-Sub
FDA Pre-Submission Q-Sub Toolkit — request letter template, meeting agenda, background package guide...
Human Factors & Usability
Human Factors and Usability Engineering Toolkit — HFE plan, URRA, formative study protocol, summativ...
510(k) Substantial Equivalence
510(k) Substantial Equivalence Toolkit — predicate comparison, SE summary, performance testing matri...
FDA Inspection Readiness
FDA Inspection Readiness Toolkit — mock audit protocol, inspection readiness checklist, 483 observat...
Sterilization Validation
Sterilization Validation Toolkit — validation plan, biological indicator protocol, SAL calculation, ...
510(k) Predicate Strategy
510(k) Predicate Strategy Toolkit — predicate search template, comparison matrix, SE argument, techn...
IVD/IVDR Regulatory
IVD/IVDR Regulatory Compliance Toolkit — IVDR classification guide, performance evaluation plan, sci...
EU MDR PMCF
EU MDR PMCF Toolkit — PMCF plan template, evaluation report, literature search protocol, clinical da...
510k Pathway & De Novo
510k Pathway Determination Toolkit — regulatory pathway selection guide, substantial equivalence wor...
Clinical IDE Toolkit
Clinical Investigations and IDE Toolkit — IDE application guide, clinical investigation plan, IRB ch...
IVDR Classification
IVDR Classification Toolkit — Annex VIII rules guide, risk class worksheet, intended purpose templat...
Electrical Safety & EMC
Electrical Safety and EMC Toolkit — IEC 60601-1 test plan, compliance checklist, EMC test plan (Edit...
NB Audit Preparation
EU MDR Notified Body Audit Preparation Toolkit — readiness checklist, technical documentation index,...
Recalls & FSCA
Medical Device Recalls and FSCA Toolkit — recall strategy guide, notification letter templates, effe...
Regulatory Strategy Roadmap
Regulatory Strategy Roadmap Toolkit — regulatory strategy memo, product classification worksheet, su...
21 CFR Part 11
21 CFR Part 11 Electronic Records Toolkit — gap assessment, system validation protocol, audit trail ...
IEC 62304 Software Lifecycle
IEC 62304 Software Lifecycle Toolkit — software development plan, SRS template, architecture design,...
PMA Application
PMA Application Toolkit — PMA structure guide, nonclinical summary, clinical data summary, manufactu...
MDR & Vigilance Reporting
MDR and Vigilance Reporting Toolkit — FDA reportability decision framework, MedWatch 3500A template,...
Global Regulatory Strategy
Global Regulatory Strategy Toolkit — pathway comparison matrix, market sequencing framework, unified...
V&V Master Plan
V&V Master Plan Toolkit — V&V master plan, verification protocol, validation protocol, traceability ...
EU MDR NB Submission
EU MDR Notified Body Submission Toolkit — NB application checklist, technical file index, GSPR compl...
EMC Testing
EMC Testing Toolkit — IEC 60601-1-2 test plan, electromagnetic environment classification, pre-compl...
FDA Consent Decree Recovery
FDA Consent Decree Recovery Toolkit — remediation roadmap, CAPA program rebuild, third-party expert ...
ISO 13485 Certification
ISO 13485 Certification Readiness Toolkit — clause-by-clause gap analysis, Stage 1 and Stage 2 audit...
Combination Products
Combination Products Toolkit — PMOA determination, regulatory strategy memo, drug-device design cont...
Recall & FSCA
Recall and FSCA Toolkit — FDA recall strategy, recall notification package, customer notification le...
Biocompatibility & TRA
Biocompatibility and TRA Toolkit — biological evaluation plan, toxicological risk assessment, chemic...
Clinical Evidence Summary
Clinical Evidence Summary Toolkit — clinical evidence summary, state of the art review, benefit-risk...
Special & Abbreviated 510k
Special and Abbreviated 510k Toolkit — eligibility checklist, guidance document mapping, submission ...
SaMD Clinical Evaluation
SaMD Clinical Evaluation Toolkit — IMDRF clinical evaluation plan, algorithm performance protocol, r...
Cleaning & Reprocessing
Cleaning and Reprocessing Toolkit — cleaning validation protocol, reprocessing IFU template, disinfe...
Class III PMA Track
PMA Track Toolkit — PMA application structure guide, IDE-to-PMA transition plan, pivotal study desig...
510k Performance Testing
510k Performance Testing Toolkit — bench test plan, test protocol templates, performance data summar...
PMCF Study Design
PMCF Study Design Toolkit — PMCF study design guide, observational study protocol, registry study te...
Core Compliance Toolkits
Essential procedures for FDA, EU MDR, and ISO 13485 compliance
QMSR Transition
Complete QMSR transition toolkit with gap analysis, implementation timeline, and compliance checklis...
510(k) Submission
Everything you need for a successful 510(k) submission. Predicate search strategy, RTA checklist, su...
ISO 14971 Risk Management
Complete ISO 14971:2019 risk management file templates. Risk analysis, dFMEA, pFMEA, benefit-risk an...
Design Controls
Complete design controls toolkit with design input, output, verification, validation, and DHF templa...
CAPA System
Complete CAPA toolkit with root cause analysis (5-Why, Fishbone), effectiveness verification, trendi...
Internal Audit
Complete internal audit toolkit with audit procedure, scheduling, checklists covering all ISO 13485 ...
Supplier Controls
Complete supplier controls toolkit with qualification procedures, audit checklists, quality agreemen...
SaMD & Cybersecurity
Complete SaMD toolkit with IEC 62304 software lifecycle, SOUP management, cybersecurity documentatio...
Post-Market Surveillance
Complete post-market surveillance toolkit with PMS plan, PMCF templates, PSUR guidance, complaint ha...
Complaint Handling
Complete complaint handling toolkit with FDA 820.198 compliant procedures, MDR reportability assessm...
Process Validation
Complete process validation toolkit with IQ, OQ, PQ protocols, validation master plan, and FDA 21 CF...
Labeling & IFU
Complete labeling toolkit with FDA 21 CFR 801 and EU MDR labeling requirements, IFU templates, UDI g...
Medical Device Cybersecurity
Medical Device Cybersecurity Toolkit: FDA Premarket + IEC 62443 Templates - complete templates for m...
QMS Documentation Kit
QMS Documentation Starter Kit: ISO 13485 Core Document Templates - complete templates for medical de...
SaMD Classification
SaMD Classification and Regulatory Strategy Toolkit: FDA + IMDRF Templates - complete templates for ...
Incoming Inspection
Incoming Inspection and Receiving Inspection Toolkit: FDA 820.80 Templates - complete templates for ...
Document Control
Document Control Procedure Toolkit: FDA 820.40 + ISO 13485 Templates - complete templates for medica...
Management Review
Management Review Toolkit: FDA 820.20 + ISO 13485 Section 5.6 Templates - complete templates for med...
Training Records
Medical Device Training Records Toolkit: FDA 820.25 + ISO 13485 Templates - complete templates for m...
Complaint Handling and MDR
Complaint Handling and MDR Reporting Toolkit: FDA 820.198 + Part 803 Templates - complete templates ...
CAPA Effectiveness
Corrective Action Effectiveness Verification Toolkit: FDA 820.100 Templates - complete templates for...
Nonconforming Product
Nonconforming Product Control Toolkit: FDA 820.90 + ISO 13485 Templates - complete templates for med...
Risk-Based Thinking
Risk-Based Thinking and Process Approach Toolkit: ISO 13485:2016 Templates - complete templates for ...
DMR and DHR Toolkit
Device Master Record and Device History Record Toolkit: FDA 820.181 Templates - complete templates f...
Change Control
Change Control and Design Change Toolkit: FDA 820.40 + 820.30(i) Templates - complete templates for ...
Supplier Qualification
Supplier Qualification and Approved Supplier List Toolkit: FDA 820.50 Templates - complete templates...
UDI and Device Registration
UDI and Device Registration Toolkit: GUDID + EUDAMED Compliance Templates - complete templates for m...
Device Labeling Requirements
Medical Device Labeling Requirements Toolkit: FDA 21 CFR Part 801 + EU MDR Templates - complete temp...
ISO 14971 Risk Management
ISO 14971 Risk Management Toolkit: Complete ISO 14971:2019 Templates - risk management plan, FMEA, r...
Device Labeling Requirements
Device Labeling Requirements Toolkit — labeling requirements checklist, IFU review checklist, UDI ve...
Software & CSV Validation
Computer System Validation Toolkit — CSV plan, IQ/OQ/PQ protocols, test scripts, validation report, ...
GMP & GDP Compliance
GMP GDP Compliance Toolkit — 150+ point gap assessment, GDP qualification checklist, batch record te...
Complaint Investigation
Complaint Investigation Toolkit — complaint procedure, investigation form, MDR reportability workshe...
Quality Metrics & KPI
Quality Metrics and KPI Dashboard Toolkit — QMS performance dashboard, management review metrics, CA...
Design History File (DHF)
Design History File Toolkit — DHF index, design review template, design input requirements, V&V plan...
510k Post-Clearance
510k Post-Clearance Compliance Toolkit — change assessment SOP, significant change determination wor...
UDI Compliance
UDI Compliance Toolkit — UDI implementation plan, GUDID submission checklist, DI/PI assignment works...
Shelf Life & Aging
Medical Device Shelf Life Toolkit — accelerated aging protocol (ASTM F1980), real-time aging plan, s...
QMSR Gap Analysis
QMSR Gap Analysis Toolkit — side-by-side comparison matrix, gap analysis worksheet, QMS update actio...
Contract Manufacturer Oversight
Contract Manufacturer Oversight Toolkit — CM qualification procedure, quality agreement template, au...
Annual Product Review
Annual Product Review Toolkit — APR procedure, data analysis template, PQR template, KPI dashboard, ...
CAPA Root Cause Investigation
CAPA Root Cause Investigation Toolkit — 5-Why template, fishbone diagram, fault tree analysis, failu...
Predicate Research Strategy
Predicate Research Toolkit — 510k database search protocol, predicate evaluation matrix, FDA-format ...
Intended Use & Indications
Intended Use Toolkit — intended use statement, indications for use, scope analysis, EU MDR intended ...
GDP & Cold Chain
GDP and Cold Chain Toolkit — GDP procedure, cold chain validation protocol, temperature excursion in...
Quality Metrics Reporting
Quality Metrics Toolkit — FDA voluntary reporting data package, QMS KPI dashboard, management review...
Manufacturing Process Control
Manufacturing Process Control Toolkit — process control procedure, batch record (DHR), in-process in...
EU MDR Authorized Rep
EU MDR Authorized Representative Toolkit — AR mandate template, economic operator obligations checkl...
Clinical Ethics & IRB
Medical Device Ethics and IRB Toolkit — IRB application template, informed consent form, protocol am...
Audit Finding Closeout
QMS Audit Finding Closeout Toolkit — audit finding response template, corrective action plan, object...
Getting Started
Foundation templates and multi-market compliance
QMS Foundations Pack
Essential QMS foundation templates: document control, training records, and management review proced...
FDA + EU MDR Dual Compliance
Harmonized procedures that satisfy both FDA and EU MDR requirements. Single documentation system for...
Regulatory Cover Letters
Regulatory Submission Cover Letter Toolkit — 510k cover letter, PMA cover letter, De Novo request le...
Startup Launch Checklist
Medical Device Startup Launch Toolkit — QMS foundation checklist, regulatory pathway confirmation, d...
RA Job Aid Library
RA Job Aid Toolkit — FDA submission timelines, 510k completeness checklist, regulatory pathway decis...
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