Over the years, experience and practical application have led THEMA to develop documents, support materials and content to help medical organisations implement regulatory requirements. Speed up the compliance process with templates and checklists on quality management system and regulatory activities in different countries, written by THEMA experts and validated by an incredible number of uses and checks.

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Checklist 21CFR 11

Language: EN

Checklist prescreening 510(k)

Language: EN

Checklist prescreening MDL

Language: EN

Checklist UDI
 . 

Language: EN

Clinical Evaluation Plan (CEP) module

Language: EN

Essential requirements table – Australia

Language: EN

Essential requirements table – Brazil

Language: EN

Essential requirements table – Canada

Language: EN

IEC 62304 Software Validation Module

Language: EN

IVDR Technical Documentation

Language: EN

Label translation – Instruction

Language: EN

Management procedure (SOP) Clinical Evaluation

Language: EN

Management procedure (SOP) pre-Clinical Evaluation
 . 

Language: EN

Management procedure (SOP) post-market surveillance

Language: EN

Management procedure (SOP) Risk management ISO 14971

Language: EN

MDR Technical Documentation

Language: EN

Note to File module
 . 

Language: EN

Performance Evaluation Plan (PEP) form

Language: EN

Post-market surveillance plan module (PMSP)

Language: EN

Post-market Surveillance Report (PMSR) module

Language: EN

PRRC Designation Letter – Authorised Representative

Language: EN

PRRC Designation Letter – Manufacturer

Language: EN

PSUR (Periodic Safety Update Report) module

Language: EN

QTA Brazilian Registration Holder (BRH) Brazil

Language: EN

QTA Importer/Distributor – Canada

Language: EN

QTA Initial Importer
 . 

Language: EN

QTA Legal Agent – South Korea

Language: EN

QTA Legal Agent China
 . 

Language: EN

QTA Legal Agent Russia
 . 

Language: EN

QTA Marketing Authorization Holder (DMAH o MAH) Japan

Language: EN

QTA MDR/IVDR Authorised Representative

Language: EN

QTA MDR/IVDR Distributor
 . 

Language: EN

QTA MDR/IVDR Supplier
 . 

Language: EN

QTA Sponsor – Australia
 . 

Language: EN

QTA US Agent USA
 . 

Language: EN

Risk management File ISO 14971

Language: EN

Trend Analysis Module
 . 

Language: EN

Usability Report Form EN 60601-1-6

Language: EN

Usability Validation Module EN 62366-1

Language: EN