How can Dyadem help? - Reliability & Quality

Your mission is to reduce warranty recalls and product defects. Your department's mandate is to optimize manufacturing processes. You need to better manage recommendations and control plans. You could be trying to achieve these with a spreadsheet, word processor or homegrown software but you are not getting the results you want.

Dyadem offers a proven track record of helping our clients to achieve success in reliability and is committed to providing industry professionals with constructive solutions to meet their reliability assessment and management objectives. Dyadem offers software solutions, facilitation services and training.

FMEA for Medical Devices is the most comprehensive Failure Mode and Effects software for the manufacture of medical devices. It is fully customizable to handle any type of Failure Mode and Effects Analysis including D-FMEA, P-FMEA, A-FMEA and S-FMEA, as well as Failure Mode, and Effects Criticality Analysis (FMECA). It supports ISO 9000, ISO 13485, ISO 13488, ISO 14971, EN standards, 510(k)/Pre-market Notification, MIL-STD-1629A, FDA QSR, GMP/cGMP and Advanced Quality Planning (AQP).

FMEA for Medical Devices helps engineers recognize and mitigate quality issues before they become serious problems. It allows you to standardize your, as well as your suppliers', FMEA's through the use of corporate templates and its knowledge-based checklists. It can be customized to interface with other areas of your quality system and allows for real-time linkages between such items as the process flow diagram, PFMEA and control plans. FMEA for Medical Devices allows you to track any document changes, ensuring that all the changes made by your engineers are recorded. Its recommendation management allows you to provide analysis on the cost of implementing changes as well as track the progress of the assigned recommendations throughout the study.

Dyadem can provide the resources needed to complement your existing project team. We will review the project and its goals at the beginning of the project to ensure that it provides the information, analysis and solutions that meet your needs. This is followed by a series of onsite meetings where our facilitator guides your team to identify the risks associated with the project and assists them in analyzing these scenarios further. Finally, the facilitator provides a report that includes all the findings and recommendations of this study.

Dyadem offers training in FMEA. Our training courses offer a mix of lecture and workshop sessions both on the most current methodologies for hazard identification and mitigation and on using Dyadem software to complete your studies. These courses will train your staff in conducting efficient and comprehensive FMEA's internally.

For more information on our services, training and software, contact us at (905) 882-5055.