Logiciel pour Affaires réglementaires

The right risk management according to the EN ISO 14971:2013 is one of the issues of the “Regulatory affairs” function.

Risk Management 14971 Software is the essential tool to facilitate your daily work!

ISO 14971 Software You Need !

Risk Management RM 14971 allows you to
logiciel-affaires-reglementaires

  • Save time when creating new risk studiesbecause it really structures information and integrates many elements: the medical device lifecycle (DM): design, manufacture, transport, storage, operation, maintenance, end of life,  repositories of initiating events, hazards, damage on humans, other equipment and the resulting environment
  • facilitate updates: since you are working within a database, each change is immediately reflected in the documents.
  • manage easily action plans, status, reminders, etc.
  • print automatically many documents  (internal work or communication), and in particular risk management report.

Consistency between Design and Risk Management

Medical Device Suite integrates also other modules for Functional Analysis and FMEA which allow to work in coherence with the “Design – Office” services on the development and manufacturing of medical devices:

  • Medical Device Data are structured and shared in a common database with designers
  • Access are secured, adapted to each role
  • The methodology suits the context: FMEA and / or EN ISO 14971 risk analysis.

amdec-iso-14971

Next Step ?

Our team remains at your entire disposal for any precision or to schedule a demonstration when you want.

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