Inspections and Audits

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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

Life science companies using software in clinical trials, software developers, and producer of artificial intelligence products need to know what software is a medical device and what’s not. View

Sampling raises questions for the auditor, such as the number of records to sample, counting nonconforming records and limits on acceptance. Dan O’Leary, one of FDAnews’s most popular presenters, will examine the issues in audit sampling and provide the answers you need for planning. View

The Voluntary Malfunction Summary Reporting Program was finalized in August 2018 and lets manufacturers report certain device malfunction medical device reports (MDRs) in summary form on a quarterly basis instead of the typical 30 days for each individual report. View

Smart medical devices have underlying cybersecurity and privacy risks. FDAnews has invited global cybersecurity expert Norma Krayem to walk you through the rapidly changing global regulatory landscape and show you new coping strategies. View

In 90 fast-paced minutes attorneys Mike Druckman and Blake Wilson of Hogan Lovells US LLP will provide insights into how under DAIA the framework for LDTs, companion devices and targeted pharmaceutical therapies may change in the near future, and how to start preparing for these changes. View

As medical device software and other technology continue to advance at a rapid pace, the FDA’s regulatory policies and processes are being forced to evolve to keep pace with innovation. View