ISO 14971 Compliance

MasterControl Ensures that ISO 14971 Compliance is Accurately Implemented in an Enterprise.

ISO 14971 compliance is critical for avoiding the hazards associated with medical devices, including in vitro medical devices. ISO 14971 specifies the process for evaluating and controlling risks, and monitoring the success of the controls.

Zugehörige Videos

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Q&A: DIN EN ISO 14971: Risikomanagement für Medizingerätehersteller COMPLIANCE ACCELERATED
Webinar: Integrating ISO 14971 and ICH Q9 Into Your Quality System
Webinar: ISO 9001:2015 Part 1: Prepare for Impending Changes
White Paper: Ten Signs Your CEO Still Has No Idea About ISO 9001 and Lean
White Paper: Sechs Wege zur Optimierung Ihres Qualitätsmanagementsystems und zur Sicherstellung von FDA- und ISOCompliance
White Paper: ISO 13485 -- Change? Do I Have To??
Toolkit: 11 Free Resources to Boost Your Medical Device FDA Readiness
Firmenanalyse: Risk Management: Best Practices for Medical Device Profitability
Produktdatenblatt: MasterControl QMS and QEM Systems for ISO Guided Companies
Demo Video: MasterControl Quality Management System (QMS) Overview

ISO 14971 Compliance Questions Manufacturers Have

Many manufacturers of medical devices have questions about ISO 14971 compliance--questions such as those listed below:

  • Was ist die ISO und was sind die Vorteile einer ISO-Zertifizierung ?
  • What is ISO 14971 compliance?
  • Was bedeutet Risikomanagement?
  • Was ist die Verbindung zwischen ISO 13485 und ISO 14971?
  • Wie kann MasterControl die Hersteller medizinischer Geräte bei der Einhaltung von ISO 14971-Anforderungen unterstützen?

How ISO 14971 Compliance Helps Medical Device Manufacturers

ISO 14971 compliance helps medical device manufacturers introduce safe medical devices into the marketplace by evaluating and controlling the risks associated with a medical device, and by evaluating a device's interactions with other devices.

Kürzlich überarbeitete Normen für ISO 14971-Konformität

The recently revised standards for ISO 14971 compliance (ISO 14971 2007) provide questions medical device manufacturers can use to identify medical device characteristics that could have an impact on safety.

Among other things, the revisions to ISO 14971 compliance provide examples of hazards, foreseeable sequences of events, and hazardous situations. This will undoubtedly entail stricter standards and make it more important than ever for manufacturers of medical devices to ensure that their methods for ISO 14971 compliance are up to the task of assuring compliance.

Other ISO Standards that May be Relevant to ISO 14971 Compliance

Because everything to achieve ISO 14971 Compliance is connected with everything else, other ISO standards you may want to be familiar with (and that MasterControl can help with) include: ISO 9000 2000, ISO 9001 2000 (these are general quality management standards); ISO 14000 (environmental management standards in production environments), and ISO 13485 (medical device quality management requirements for regulatory purposes).

For More Information on ISO 14971 Compliance

To learn more about MasterControl and how MasterControl solutions can assure ISO 14971 compliance, please feel free to contact a MasterControl representative.