Discovering the quality and regulatory requirments of the ISO 14971 standard

Home > Discovering the quality and regulatory requirments of the ISO 14971 standard

Objectives

  • Understanding the terms and the vocabulary
  • Understanding risk management methods based on the requirements of the ISO 14971:2013 standard
  • Identifying the documents necessary to demonstrate the compliance of risk management activities
  • Understanding the challenges of the ISO 14971 standards and its links with EC marking for medical devices, as well as its links with the 2016 version of the ISO 13485 quality standard

Audience concerned

Manufacturers/sub-contractors/distributors of MDs:
– Regulatory affairs/quality managers
– Staff with regulatory monitoring tasks
– Heads of Departments such as: Production, R&D, Purchasing, etc.


Aim

Acquiring the basics

Programme summary

  1. Introduction and objectives
  2. Reminder of regulatory aspects
  3. Need for the concept of risk management
  4. Presentation of the ISO 14971:2013 standard and its aims
  5. Risk management approach
  6. Risk assessment (with FMEA method)
  7. Risk control (with FMEA method)
  8. Risk management documentation (in connection with ISO 13485:2016)
  9. Conclusion

Prerequisites

  • Knowledge of quality management principles
  • Knowledge of the medical devices sector

Duration

1 day
7-hour classroom attendance

Inscription

Download the registration form

Date des formations CaduCeum Academy

Ref : CA14971

Informations and registration : academy@caduceum.co.uk