Dyadem, Ontario, Canada, which specializes in quality lifecycle management and risk lifecycle management solutions, has announced that Cochlear Limited, NSW, Australia, an industry leader in hearing implant innovation, is using software from Dyadem to enhance and standardize its quality assessments.

Dyadem’s FMEA-Med, a software solution that helps automate compliance reporting, enables Cochlear to link risk and quality assessments, and to set a new standard in quality for its hearing implant solutions. Cochlear’s   solutions enable thousands of hearing-impaired people to improve their range of hearing and live fuller lives.

FMEA-Med is a software solution that delivers industry-standard failure mode and effects analysis (FMEA) reports for medical device and pharmaceutical manufacturers. The FMEA methodology improves quality and
prevents potential flaws in hardware design and manufacturing processes in a variety of industries. Dyadem’s FMEA-Med helps manage quality lifecycle management processes, and was built to reflect the standards and operating environments of the medical device industry. This is essential to an industry that is regulated heavily, and where poor product quality has unique consequences.

With sites in Australia and Sweden now using FMEA-Med, Cochlear is able to standardize its risk assessments and risk rankings, allowing it to keep track of specific FMEA studies and compare the design and production processes for all implant components.

"Previously, different terminology and risk rankings were used across various departments and components, making it difficult to accurately compare and link DFMEA (Design FMEA) and PFMEA (Process FMEA) studies," said Anna Windevall, manufacturing operations engineer, Cochlear Bone Anchored Solutions in
Sweden. "With Dyadem’s FMEA-Med, Cochlear can now link and share studies across departments and sites, making it much easier to implement a company standard of quality based on comparable and accurate risk

Previously using a basic spreadsheet for its studies, Cochlear quickly found that the cumbersome documentation and inability to link studies made for a frustrating assessment process. Since implementing FMEA-Med,
Cochlear has been able to more easily show management where investment dollars should be allocated, and ensuring that its high standard of quality remains consistent.

"Medical device companies have traditionally had challenges ensuring consistency and accuracy in their risk assessments, but with our quality lifecycle management solutions, we have given the industry a legitimate
opportunity to address this," said Kevin North, president and CEO of Dyadem. "Cochlear is proving how easy it is to create quality products, be on the cutting edge of technology, and improve competitiveness and productivity, all at the same time, and without compromise."

Dyadem provides software and services that empower companies to manage quality, mitigate risks, achieve
regulatory compliance, plan for business continuity, and improve profitability. Dyadem works with 85% of the Fortune 500 companies and serves the high tech and electronics, medical devices, oil and gas, chemical, automotive, pharmaceutical, and aerospace and defense industries.

For more than 25 years, Cochlear has developed, manufactured, and marketed cochlear implants, now numbering more than 120,000 produced worldwide. In addition to cochlear implants, Cochlear manufactures the Baha, a bone conduction hearing solution for people with significant conductive hearing loss, mixed hearing loss, or single-sided deafness.