The Brazilian Market: A Regulatory Overview for Orthopaedic Products
Most Brazilian surgeons use imported products, making the country attractive for international companies. Placing products on the market means creating...
Most Brazilian surgeons use imported products, making the country attractive for international companies. Placing products on the market means creating...
Among the Agency’s 2018 priorities is an alternative, fast-track 510(k) pathway for certain devices....
FDA published its guidance on additive manufacturing technical considerations, outlining the Agency’s long-awaited position on use of the technology for...
The Centers for Medicare & Medicaid Services (CMS) made changes to the bundled payment model for Comprehensive Care for Joint...
Consider use of the acceptance sampling approach or the six sigma acceptable error approach to determine a sample size using...
The elements are derived from the biological, mechanical or clinical performance requirements of the device and regulatory requirements for performance...
While device manufacturers were slow to adopt the program in its pilot days, the initiative has gained traction since FDA...
Martin Browning from EduQuest provides insight on evaluations and audits: "All of us who conduct audits recognize that most of them...
FDA did not offer device companies new direction on methods to direct mark, as it would be difficult to account...
Big changes are underway for the European market and how it regulates medical devices with the recent unveiling of the...
Corrective and Preventive Actions or CAPA touches nearly every process in the Quality Management System (QMS). Read insight gained by...
Denise Dion from EduQuest provides advice on when to update your risk documentation...
The Centers for Medicare & Medicaid Services (CMS) released two proposals related to total joint reconstruction that could impact procedure...
EduQuest, a global team of FDA compliance experts, answers industry’s pressing questions. In this round, Denise Dion, Vice President of...
The complexity of reimbursement may be great, but the burden may be lessened if you begin with the end in...
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