Medical Device Compliance Toolkits
Professional templates for FDA, EU MDR, and ISO 13485 compliance. Built by regulatory experts. Ready for immediate use.
Complete Compliance Suite
All toolkits in one package. 100+ professional templates covering the entire QMS lifecycle.
98 toolkits found
QMS Foundations Pack
Essential QMS foundation templates: document control, training records, and management review procedures. Perfect starti...
9 documents included
FDA + EU MDR Dual Compliance
Harmonized procedures that satisfy both FDA and EU MDR requirements. Single documentation system for US and European mar...
6 documents included
QMSR Transition
Complete QMSR transition toolkit with gap analysis, implementation timeline, and compliance checklists. Align your QMS w...
6 documents included
510(k) Submission
Everything you need for a successful 510(k) submission. Predicate search strategy, RTA checklist, substantial equivalenc...
8 documents included
ISO 14971 Risk Management
Complete ISO 14971:2019 risk management file templates. Risk analysis, dFMEA, pFMEA, benefit-risk analysis, and producti...
8 documents included
Design Controls
Complete design controls toolkit with design input, output, verification, validation, and DHF templates. Meet FDA 21 CFR...
9 documents included
CAPA System
Complete CAPA toolkit with root cause analysis (5-Why, Fishbone), effectiveness verification, trending, and FDA 820.100 ...
8 documents included
Internal Audit
Complete internal audit toolkit with audit procedure, scheduling, checklists covering all ISO 13485 clauses, and audit r...
8 documents included
Supplier Controls
Complete supplier controls toolkit with qualification procedures, audit checklists, quality agreements, and incoming ins...
8 documents included
SaMD & Cybersecurity
Complete SaMD toolkit with IEC 62304 software lifecycle, SOUP management, cybersecurity documentation, and FDA SaMD guid...
9 documents included
Post-Market Surveillance
Complete post-market surveillance toolkit with PMS plan, PMCF templates, PSUR guidance, complaint handling, and vigilanc...
7 documents included
Complaint Handling
Complete complaint handling toolkit with FDA 820.198 compliant procedures, MDR reportability assessment, and vigilance r...
7 documents included
Process Validation
Complete process validation toolkit with IQ, OQ, PQ protocols, validation master plan, and FDA 21 CFR 820.75 compliant t...
7 documents included
Labeling & IFU
Complete labeling toolkit with FDA 21 CFR 801 and EU MDR labeling requirements, IFU templates, UDI guidance, and symbol ...
7 documents included
MDSAP Audit Prep
Complete MDSAP audit preparation toolkit covering all 5 participating countries. Mock audit checklists, common findings,...
8 documents included
Clinical Evaluation (CER)
Complete clinical evaluation toolkit with CER templates, PMCF plans, biocompatibility assessment, and EU MDR Article 61 ...
8 documents included
Clinical Investigation
Complete clinical investigation toolkit with IDE application templates, clinical protocol, informed consent, and study m...
8 documents included
Medical Device Cybersecurity
Medical Device Cybersecurity Toolkit: FDA Premarket + IEC 62443 Templates - complete templates for medical device compli...
6 documents included
QMS Documentation Kit
QMS Documentation Starter Kit: ISO 13485 Core Document Templates - complete templates for medical device compliance....
6 documents included
SaMD Classification
SaMD Classification and Regulatory Strategy Toolkit: FDA + IMDRF Templates - complete templates for medical device compl...
6 documents included
Incoming Inspection
Incoming Inspection and Receiving Inspection Toolkit: FDA 820.80 Templates - complete templates for medical device compl...
6 documents included
Document Control
Document Control Procedure Toolkit: FDA 820.40 + ISO 13485 Templates - complete templates for medical device compliance....
6 documents included
Management Review
Management Review Toolkit: FDA 820.20 + ISO 13485 Section 5.6 Templates - complete templates for medical device complian...
6 documents included
Training Records
Medical Device Training Records Toolkit: FDA 820.25 + ISO 13485 Templates - complete templates for medical device compli...
6 documents included
Complaint Handling and MDR
Complaint Handling and MDR Reporting Toolkit: FDA 820.198 + Part 803 Templates - complete templates for medical device c...
6 documents included
CAPA Effectiveness
Corrective Action Effectiveness Verification Toolkit: FDA 820.100 Templates - complete templates for medical device comp...
6 documents included
Nonconforming Product
Nonconforming Product Control Toolkit: FDA 820.90 + ISO 13485 Templates - complete templates for medical device complian...
6 documents included
Risk-Based Thinking
Risk-Based Thinking and Process Approach Toolkit: ISO 13485:2016 Templates - complete templates for medical device compl...
6 documents included
DMR and DHR Toolkit
Device Master Record and Device History Record Toolkit: FDA 820.181 Templates - complete templates for medical device co...
6 documents included
Change Control
Change Control and Design Change Toolkit: FDA 820.40 + 820.30(i) Templates - complete templates for medical device compl...
6 documents included
Supplier Qualification
Supplier Qualification and Approved Supplier List Toolkit: FDA 820.50 Templates - complete templates for medical device ...
6 documents included
UDI and Device Registration
UDI and Device Registration Toolkit: GUDID + EUDAMED Compliance Templates - complete templates for medical device compli...
6 documents included
Environmental Monitoring
Environmental Monitoring and Cleanroom Qualification Toolkit: ISO 14644 Templates - complete templates for medical devic...
6 documents included
Biocompatibility Strategy
Biocompatibility Testing Strategy Toolkit: ISO 10993-1:2018 Templates - complete templates for medical device compliance...
6 documents included
Sterile Packaging Validation
Packaging and Sterile Barrier System Validation Toolkit: ISO 11607 Templates - complete templates for medical device com...
6 documents included
Device Labeling Requirements
Medical Device Labeling Requirements Toolkit: FDA 21 CFR Part 801 + EU MDR Templates - complete templates for medical de...
6 documents included
CER Literature Review
Clinical Evaluation Report (CER) and Literature Review Toolkit: EU MDR Templates - complete templates for EU MDR clinica...
6 documents included
EU MDR Technical Docs
EU MDR Technical Documentation Toolkit: Annex II + GSPR Templates - complete templates for EU MDR compliance....
6 documents included
ISO 14971 Risk Management
ISO 14971 Risk Management Toolkit: Complete ISO 14971:2019 Templates - risk management plan, FMEA, risk evaluation, risk...
6 documents included
FDA Warning Letter Response
FDA Warning Letter Response Toolkit — root cause analysis, CAPA plan, formal response letter template, and 30/60/90-day ...
6 documents included
FDA Pre-Submission Q-Sub
FDA Pre-Submission Q-Sub Toolkit — request letter template, meeting agenda, background package guide, questions list, re...
6 documents included
Human Factors & Usability
Human Factors and Usability Engineering Toolkit — HFE plan, URRA, formative study protocol, summative validation protoco...
6 documents included
510(k) Substantial Equivalence
510(k) Substantial Equivalence Toolkit — predicate comparison, SE summary, performance testing matrix, differences analy...
6 documents included
Software & CSV Validation
Computer System Validation Toolkit — CSV plan, IQ/OQ/PQ protocols, test scripts, validation report, 21 CFR Part 11 check...
6 documents included
FDA Inspection Readiness
FDA Inspection Readiness Toolkit — mock audit protocol, inspection readiness checklist, 483 observation response framewo...
6 documents included
Sterilization Validation
Sterilization Validation Toolkit — validation plan, biological indicator protocol, SAL calculation, cycle development re...
6 documents included
510(k) Predicate Strategy
510(k) Predicate Strategy Toolkit — predicate search template, comparison matrix, SE argument, technological differences...
6 documents included
IVD/IVDR Regulatory
IVD/IVDR Regulatory Compliance Toolkit — IVDR classification guide, performance evaluation plan, scientific validity tem...
6 documents included
EU MDR PMCF
EU MDR PMCF Toolkit — PMCF plan template, evaluation report, literature search protocol, clinical data gap analysis, stu...
6 documents included
510k Pathway & De Novo
510k Pathway Determination Toolkit — regulatory pathway selection guide, substantial equivalence worksheet, predicate co...
6 documents included
Clinical IDE Toolkit
Clinical Investigations and IDE Toolkit — IDE application guide, clinical investigation plan, IRB checklist, adverse eve...
6 documents included
IVDR Classification
IVDR Classification Toolkit — Annex VIII rules guide, risk class worksheet, intended purpose template, technical justifi...
6 documents included
GMP & GDP Compliance
GMP GDP Compliance Toolkit — 150+ point gap assessment, GDP qualification checklist, batch record template, deviation SO...
6 documents included
Electrical Safety & EMC
Electrical Safety and EMC Toolkit — IEC 60601-1 test plan, compliance checklist, EMC test plan (Edition 4), essential pe...
6 documents included
NB Audit Preparation
EU MDR Notified Body Audit Preparation Toolkit — readiness checklist, technical documentation index, NB deficiency respo...
6 documents included
Complaint Investigation
Complaint Investigation Toolkit — complaint procedure, investigation form, MDR reportability worksheet, root cause analy...
6 documents included
Recalls & FSCA
Medical Device Recalls and FSCA Toolkit — recall strategy guide, notification letter templates, effectiveness check prot...
6 documents included
Quality Metrics & KPI
Quality Metrics and KPI Dashboard Toolkit — QMS performance dashboard, management review metrics, CAPA trend analysis, c...
6 documents included
Design History File (DHF)
Design History File Toolkit — DHF index, design review template, design input requirements, V&V plan, design transfer ch...
6 documents included
Regulatory Strategy Roadmap
Regulatory Strategy Roadmap Toolkit — regulatory strategy memo, product classification worksheet, submission timeline, g...
6 documents included
510k Post-Clearance
510k Post-Clearance Compliance Toolkit — change assessment SOP, significant change determination worksheet, annual chang...
6 documents included
UDI Compliance
UDI Compliance Toolkit — UDI implementation plan, GUDID submission checklist, DI/PI assignment worksheet, EUDAMED regist...
6 documents included
Shelf Life & Aging
Medical Device Shelf Life Toolkit — accelerated aging protocol (ASTM F1980), real-time aging plan, shelf life rationale,...
6 documents included
21 CFR Part 11
21 CFR Part 11 Electronic Records Toolkit — gap assessment, system validation protocol, audit trail checklist, electroni...
6 documents included
IEC 62304 Software Lifecycle
IEC 62304 Software Lifecycle Toolkit — software development plan, SRS template, architecture design, unit verification p...
6 documents included
PMA Application
PMA Application Toolkit — PMA structure guide, nonclinical summary, clinical data summary, manufacturing information che...
6 documents included
QMSR Gap Analysis
QMSR Gap Analysis Toolkit — side-by-side comparison matrix, gap analysis worksheet, QMS update action plan, design contr...
6 documents included
MDR & Vigilance Reporting
MDR and Vigilance Reporting Toolkit — FDA reportability decision framework, MedWatch 3500A template, EU MDR serious inci...
6 documents included
Global Regulatory Strategy
Global Regulatory Strategy Toolkit — pathway comparison matrix, market sequencing framework, unified technical documenta...
6 documents included
Contract Manufacturer Oversight
Contract Manufacturer Oversight Toolkit — CM qualification procedure, quality agreement template, audit checklist, perfo...
6 documents included
Regulatory Cover Letters
Regulatory Submission Cover Letter Toolkit — 510k cover letter, PMA cover letter, De Novo request letter, IDE applicatio...
6 documents included
V&V Master Plan
V&V Master Plan Toolkit — V&V master plan, verification protocol, validation protocol, traceability matrix, test report ...
6 documents included
EU MDR NB Submission
EU MDR Notified Body Submission Toolkit — NB application checklist, technical file index, GSPR compliance matrix, SSCP t...
6 documents included
EMC Testing
EMC Testing Toolkit — IEC 60601-1-2 test plan, electromagnetic environment classification, pre-compliance checklist, EU ...
6 documents included
Startup Launch Checklist
Medical Device Startup Launch Toolkit — QMS foundation checklist, regulatory pathway confirmation, design controls go-li...
6 documents included
FDA Consent Decree Recovery
FDA Consent Decree Recovery Toolkit — remediation roadmap, CAPA program rebuild, third-party expert management, import a...
6 documents included
ISO 13485 Certification
ISO 13485 Certification Readiness Toolkit — clause-by-clause gap analysis, Stage 1 and Stage 2 audit prep checklist, reg...
6 documents included
Combination Products
Combination Products Toolkit — PMOA determination, regulatory strategy memo, drug-device design controls integration, co...
6 documents included
Annual Product Review
Annual Product Review Toolkit — APR procedure, data analysis template, PQR template, KPI dashboard, PSUR integration gui...
6 documents included
CAPA Root Cause Investigation
CAPA Root Cause Investigation Toolkit — 5-Why template, fishbone diagram, fault tree analysis, failure mode classificati...
6 documents included
Recall & FSCA
Recall and FSCA Toolkit — FDA recall strategy, recall notification package, customer notification letter, EU MDR FSCA/FS...
6 documents included
Biocompatibility & TRA
Biocompatibility and TRA Toolkit — biological evaluation plan, toxicological risk assessment, chemical characterization ...
6 documents included
Clinical Evidence Summary
Clinical Evidence Summary Toolkit — clinical evidence summary, state of the art review, benefit-risk framework, evidence...
6 documents included
Special & Abbreviated 510k
Special and Abbreviated 510k Toolkit — eligibility checklist, guidance document mapping, submission type decision tool, ...
6 documents included
Predicate Research Strategy
Predicate Research Toolkit — 510k database search protocol, predicate evaluation matrix, FDA-format comparison table, sp...
6 documents included
Intended Use & Indications
Intended Use Toolkit — intended use statement, indications for use, scope analysis, EU MDR intended purpose statement, c...
6 documents included
GDP & Cold Chain
GDP and Cold Chain Toolkit — GDP procedure, cold chain validation protocol, temperature excursion investigation, distrib...
6 documents included
SaMD Clinical Evaluation
SaMD Clinical Evaluation Toolkit — IMDRF clinical evaluation plan, algorithm performance protocol, real-world evidence s...
6 documents included
Quality Metrics Reporting
Quality Metrics Toolkit — FDA voluntary reporting data package, QMS KPI dashboard, management review metrics report, com...
6 documents included
Cleaning & Reprocessing
Cleaning and Reprocessing Toolkit — cleaning validation protocol, reprocessing IFU template, disinfection validation, si...
6 documents included
Manufacturing Process Control
Manufacturing Process Control Toolkit — process control procedure, batch record (DHR), in-process inspection checksheets...
6 documents included
Class III PMA Track
PMA Track Toolkit — PMA application structure guide, IDE-to-PMA transition plan, pivotal study design, SSED template, ad...
6 documents included
RA Job Aid Library
RA Job Aid Toolkit — FDA submission timelines, 510k completeness checklist, regulatory pathway decision tree, 483 respon...
6 documents included
510k Performance Testing
510k Performance Testing Toolkit — bench test plan, test protocol templates, performance data summary, substantial equiv...
6 documents included
EU MDR Authorized Rep
EU MDR Authorized Representative Toolkit — AR mandate template, economic operator obligations checklist, AR agreement, E...
6 documents included
Clinical Ethics & IRB
Medical Device Ethics and IRB Toolkit — IRB application template, informed consent form, protocol amendment procedure, a...
6 documents included
PMCF Study Design
PMCF Study Design Toolkit — PMCF study design guide, observational study protocol, registry study template, patient-repo...
6 documents included
Audit Finding Closeout
QMS Audit Finding Closeout Toolkit — audit finding response template, corrective action plan, objective evidence package...
6 documents included
Not sure which toolkit you need?
Answer 3 quick questions and we'll recommend the right toolkit for your situation.
Get a Recommendation →