ISO 14971 is the only internationally recognized standard solely intended for the application of risk management to medical devices. At its core, the standard provides the global device manufacturing community with an appropriate and clear model for risk management. For regulators (FDA), ISO 14971 provides a benchmark to evaluate an organization’s risk management process. The standard recognizes the risks inherent to the use of medical devices, but demands that manufacturers reduce risk levels to a tolerable level before products go to market. To ensure compliance and absolute product safety, manufacturers can follow IS0 14971 to guide their risk management efforts.

Impact

Beyond product safety, ISO 14971 provides a broader outline for Risk Management, providing guidance on the processes for managing risks, primarily to the patient, but also to other key stakeholders. The standard calls for device manufacturers to follow a basic risk management routine spanning the entire lifecycle of a manufacturing process. This includes the creation of a process for identifying hazards, evaluating associated risks, mitigating risks, and monitoring the value of risk controls. In addition, manufacturers must measure risk beyond production, using this same process to understand and control risk(s) as the device matures in the market. The outlined requirements of ISO 14971 rigorously apply to the entire lifecycle of a device.

Challenge

Medical Device manufacturers looking to adopt the guidelines outlined in ISO 14971 often find the process difficult. Disorganized spread-sheet applications, disparate silos of risk-related records and untraceable data prevent manufacturers from demonstrating the requisite lifecycle approach to Risk Management. Without the right solution, manufacturers subject themselves to a diverse set of risks – many of which can impair their ability to remain competitive in the marketplace.

The Dyadem Solution

Dyadem provides comprehensive Quality Risk Management (QRM) solutions that enable global Medical Device companies to reduce risk management effort by 50%-80%. In addition to improved quality and reduction in compliance risks, Dyadem offers an integrated lifecycle model, linking all parts of design, production and post-market data throughout the risk management process.

• Compliance Overview
• 510(k)
• ANSI/ISA S84.01
• AS/NZ 4360
• AS 9100
• COMAH
• EPA 40 CFR part 68
• FDA
• ICH
• IEC
• ISO
  • ISO 26262
  • ISO 31000
  • ISO 9001
  • ISO 13485
  • ISO 14971
• MIL-HDBK 338b
• NUREG 0492
• OSHA
• SAE
• SEVESO II Directive