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FDAnews Announces — Postmarket Problems for Medical Devices: The Path to Resolution Workshop Feb. 19-20, 2020

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WCG FDANews Logo

WCG FDANews Logo


FALLS CHURCH, Va. (PRWEB)

Postmarket Problems for Medical Devices: The Path to Resolution

An Interactive Workshop Presented by FDAnews and Ombu Enterprises

Feb. 19-20, 2020 • Hilton Atlanta • Atlanta, GA

https://www.fdanews.com/postmarketproblemsmd

When it comes to dealing with postmarket medical device problems, there is no one-size-fits-all solution. With the US, EU and Canada following different sets of rules, knowing the latest regulatory requirements and complaint processes of each is critical

FDAnews and Ombu Enterprises can help one get more familiar with the regulatory landscape during our two-day workshop in Atlanta this February. During the workshop, attendees will:

*Discover the similarities and differences among US, EU, and Canadian systems and their process flows and decision points

*Determine the function of Quality System Regulations (QSR), ISO 13485:2016, ISO 14971:2019, and their national and regional variants

*Familiarize oneseld with multiple definitions of complaints and their implications

*Identify the characterization of records and reports and how they support regulatory requirements

*Review FDA warning letters and learn how to avoid problems

*Recognize when a design change triggers an updated regulatory submission

*Assess the decisions and timelines for field actions

As a bonus, attendees will also receive a set of Excel workbooks to help follow regulatory paths.

Conference Details:

Postmarket Problems for Medical Devices: The Path to Resolution

An Interactive Workshop Presented by FDAnews and Ombu Enterprises

Feb. 19-20, 2020 • Hilton Atlanta • Atlanta, GA

https://www.fdanews.com/postmarketproblemsmd

Tuition:

Early Bird Pricing: $1,597 (available until Jan. 22, 2020)

Regular Pricing: $1,797 (after Jan. 22, 2020)

Significant team discounts are available.

Easy Ways to Register:

Online: https://www.fdanews.com/postmarketproblemsmd

By phone: 888-838-5578 or 703-538-7600

About FDAnews:

FDAnews is the premier provider of domestic and international regulatory, legislative,

and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews’ print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA’s complex and ever-changing regulations.

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