ISO 14971 Standards


The ISO 14971 standards, when implemented correctly, establishes a risk management process that helps ensure the safety and quality of medical devices throughout the product lifecycle.

Many medical device companies strive to comply with the ISO 14971 standards to effectively address risk assessment and management. MasterControl, a developer of document control, process management and product lifecycle management software solutions for regulated companies, can help medical device companies automate compliance with the 14971 standard.

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Automating ISO 14971 Standard Compliance Automatically

MasterControl's software solutions streamline compliance with ISO 14971 standards, ISO 9001:2000 and other ISO standards. How can MasterControl help medical device companies comply with the 14971 standards? Here's a few features that MasterControl provides:

  • Document Control - The 14971 standards requires the identification of hazards (related to a medical device) and the estimation and evaluation of those risks. MasterControl can automatically streamline the control of risk related documentation and can automatically route those documents along processes designed for each level of evaluated risk.

  • Management Responsibilities - The 14971 standards requires that management create and review (on a regular basis) the policy that determines acceptable risk. MasterControl automates the creation of all documentation (including policies) and provides revision controls and electronic collaboration capabilities. MasterControl also facilities review of risk analysis and edits to the risk policy itself by automating the scheduling, notification and escalation of reviewing tasks.

  • Security - The MasterControl centralized and web-based system provides state-of-the-art securities so that all risk related information including risk management plans, risk analyses, hazards, risk control measures and risk evaluations are accessible to only those users who have been approved by system administrators. This system will help in maintaining ISO 14971 standard procedures.

  • Personnel Qualifications - The 14971 standards requires that personnel that have responsibilities related to risk management should be qualified to perform those responsibilities. MasterControl automatically deploys any type of training course and online training exams. These courses are automatically tracked and follow-ups and escalations are also automated. The system in essense performs a gap analysis on training tasks all the time.

  • Risk Management Plan and Reports - MasterControl provides an audit trail for every change that is made to a company's risk management plan and automates the reporting of risk management issues and data.

For More Information on ISO 14971 Standards

For more information in regard to the automated management of ISO 14971 standards and processes, please feel free to contact a MasterControl representative.