Inspections and Audits

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FDA-regulated health science manufacturers are speeding past the FDA in developing software to market as a medical device. Is there some way to bring your software product to market via the 510(k) clearance process as it exists now? The answer may be yes. View

Many a medical devicemaker has incurred a warning letter due to slipshod process validation. No wonder. Process validation is an exacting task, subject to strict statistical procedures and hemmed in by 21 CFR §820.75 and ISO 13485:2016. View

Devicemaker alert: The FDA is on the lookout for Part 806 violations and will deal out appropriate sanctions for violation. Can you tell the difference between a device recall and a product enhancement? View

Many a medical devicemaker has incurred a warning letter due to slipshod process validation. No wonder. Process validation is an exacting task, subject to strict statistical procedures and hemmed in by 21 CFR §820.75 and ISO 13485:2016. View

Are you prepared for your next inspection? If you said yes, you might want to think again. It’s time to discover what’s new in dealing with FDA inspectors, what they may and may not look into and what goes into the decision to issue a Form 483. View

Join us for a detailed analysis about whether the changes and reforms advanced in the past two years will remain and whether it will affect your product development and approval applications. View

John Fuson — former Associate Chief Counsel for Enforcement, FDA — will review factors that increase enforcement risks and provide insights on how enforcement progresses from inspectional observations to 483s, warning letters, seizures, injunctions and possible criminal actions or jail time. View

If you plan to continue putting devices on the European market, you’ll need to implement the EU-MDR. Dan O’Leary will explain the hybrid system where you maintain a device certificate under the MDD and a QMS under the MDR. View

As electronic technology advances, its integration into medical devices — specifically medical imaging devices — challenges the FDA to regulate the integrated devices and still allow new technologies to the market in a reasonable time. J. Lawrence Stevens, RAC — an expert witness for cases involving FDA compliance for medical devices — will discuss the latest FDA trends and how to keep your company competitive. View

Jessica Ringel — Counsel, King & Spalding, Washington, D.C. — will discuss how CDRH will prioritize digital health, advance device safety and security, offer more flexibility and options for premarket submissions, sustain high-quality servicing, provide efficient oversight, handle uncertainty in devices and engage patients. View

Mary Vater, medical device consultant at Medical Device Academy, Inc., will share best practices and tips for preparing and submitting 510(k)s. She’ll discuss common mistakes and the FDA’s current and evolving expectations for submissions. View

Bethany J. Hills, Chair, FDA Practice and Aaron Josephson, Senior Director — both of Mintz Levin — will provide a comprehensive understanding of medical device compliance and enforcement trends and the contextual relationship of policy and regulation. View