In this section, we provide a range of documentation aimed at supporting organization to reach regulatory compliance.
Different types of documents are provided:
- QMS Procedures
- Technical documentation for technical dossier preparation, according to FDA and EU MDR Requirements.
- QMS Templates or forms
- Compliance checklist, where a list of requirements on a specific topic is presented as a checklist, to help organisations to summarise all the requirements in one unique document.
- E-books, where a deep dive on a specific quality or regulatory topic is presented in an extensive form.
Showing all 18 results
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Device Master Record Template
€39,99 Add to cart -
Labelling Requirements Checklist According to EU MDR 2017/745
€29,99 Add to cart -
Medical Device Labelling Requirements: FDA and EU MDR 2017/745 Regulations
€39,00 Add to cart -
P-01 : Management Review Procedure
€59,99 Add to cart -
P-02 : Risk Management Procedure
€59,99 Add to cart -
P-03 : Internal Audit Procedure
€59,99 Add to cart -
P-04 : Human Resources and Training Management Procedure
€59,99 Add to cart -
P-05 : Data Analysis Procedure
€59,99 Add to cart -
P-06 : Computer System Validation Procedure
€59,99 Add to cart -
P-07 : Corrective and Preventive Actions (CAPA) Procedure
€59,99 Add to cart -
P-08 : Non-Conforming Products Procedure
€59,99 Add to cart -
P-09 : Change Control Procedure
€59,99 Add to cart -
P-10 Clinical Investigation Procedure
€69,99 Add to cart -
Periodic Safety Update Report (PSUR)Template
€39,99 Add to cart -
Risk Management Plan Template
€39,99 Add to cart -
T-01 : CAPA Template
€39,99 Add to cart -
T-02 : Non-Conformance Report Template
€39,99 Add to cart -
The Definitive Guideline on Post-Market Surveillance (PMS) Activities
€39,00 Add to cart