When to Submit a 510(k) for a Change to an Existing Device
Training
Online
*Indicative price
Original amount in USD:
$ 290
Description
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Type
Training
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Level
Advanced
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Methodology
Online
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Class hours
3h
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Duration
1 Day
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Start date
Different dates available
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Virtual classes
Yes
In this session you will learn what approaches are required for product changes, for process changes, Also you will learn how to decide when to submit a 510(k) for a change to an existing device.
Facilities
Location
Start date
Start date
Reviews
Subjects
- Management
- Education Studies
- Quality
- Healthcare
- Technology
- Medical
- Organizational Skills
- Clinical Studies
- Health Insurance
- Knowledge management
Teachers and trainers (1)
Adam Fleming
Event Manager
Compliance4All is a professional trainings provider for the regulated industries. It offers professional trainings for regulatory compliance professionals and offers innovative strategic consulting and advice to a broad range of organizations. These services help them to be compliant with regulatory requirements. . Compliance4All has a panel of acclaimed Experts whose professional trainings help regulatory professionals and organizations in a number of ways and take them to their goal of meeting regulatory requirements.
Course programme
Why should you Attend:This presentation uses the latest FDA thinking and guidance documents to assist the manufacturers in enhancing the predictability, consistency, and transparency of the "when to submit" decision-making process by providing a least burdensome approach, and describing in greater detail the regulatory framework, policies, and practices underlying such a decision.
Areas Covered in the Session:The main types of changes that might be made to a device: When a manufacturer modifies their device with the intent to significantly affect the safety and effectiveness of a device (for example to significantly improve clinical outcome or to mitigate a known risk) submission of a new 510(k) is likely.
Who Will Benefit:Quality ManagersQuality EngineersRegulatory AffairsSmall Business Owners
Speaker Profile:Angela Bazigos is the CEO of Touchstone Technologies Inc. She has degrees in Microbiology and Computing and 40 years of experience in the Life Sciences, Healthcare & Public Health Services. Experience combines Quality Assurance, Regulatory Compliance, Business Administration, Information Technology, Project Management, Clinical Lab Science, Microbiology, Food Safety & Turnarounds.
Event Fee: One Dial-in One Attendee Price: US $290.00
Contact Detail:Compliance4All DBA NetZealous,Phone: +1-800-447-9407Email: support@compliance4All.com
Additional information
When to Submit a 510(k) for a Change to an Existing Device
*Indicative price
Original amount in USD:
$ 290