Medical Devices

The Challenge
As a result of ISO 14971:2007 edition, management at every level are required to have visibility into the top risks that are affecting their time-to-market, compliance to regulation and cost of quality today. Given the fact that risk analysis documents are not centrally managed or standardized, reporting of risk is very difficult and time consuming. Not only does manually preparing reports require time and effort, but also the data is inherently out-of-date and subject to human error.

Another top business challenge is the need for a lifecycle approach to manage requirements and risks for traceability and compliance to FDA regulations. Currently, companies are managing these documents in disparate systems making later impact analysis due to change in requirements or risk documents a manual and error-prone process.

Determining whether product failures experienced in the market were considered in the original product design is also a key challenge in the industry. Closing the loop to ensure post-market feedback is incorporated into the design and manufacturing process provides a higher quality product and improves FDA compliance.
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 also offers an integrated lifecycle model linking all parts of design and production risk analysis. This provides full traceability for FDA compliance and the identification of critical quality attributes to align design with manufacturing.

Dyadem provides the essential elements of the ISO 14971 Risk Management System:

  1. Lifecycle approach to all risk management related documents - linking documents such as Voice-of-the-Customer (VoC), Design Input, Validation & Verification, Preliminary Hazards Analysis (PrHA), Design FMEA, Process FMEA, Control Plans, etc.
  2. Real-time visibility into quality & risk information, enabling Management to participate in the quality system and ensures timely communication and governance of risk.
  3. Knowledge libraries allow the efficient use of lessons learned to enable continuous improvement, also reducing effort and improving consistency. These capabilities avoid the risk of repeat failures across products or sites.
  4. The centralization of all risk assessments and related documents in a single database, allows searching and reporting across all risk analyses for post-market surveillance.
  5. Corrective and preventive action workflows with various root cause analysis techniques, such as 8D or 5Y. Stature can also integrate to existing CAPA systems.
Stature for Quality Risk Management (QRM)
PHA-Pro
FMEA-Pro
FTA-Pro
"In our industry, quality and risk management parameters are integrated into all aspects of research, development, production and application, as our products must perform flawlessly. Dyadem's software allows us to work in a more uniform environment, and assess quality in a standard way."

Genzyme Corporation