When to Submit a 510(k) for a Change to an Existing Device

Training

Online

£ 229.38 VAT inc.

*Indicative price

Original amount in USD:

$ 290

Description

  • Type

    Training

  • Level

    Advanced

  • Methodology

    Online

  • Class hours

    3h

  • Duration

    1 Day

  • Start date

    Different dates available

  • 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

Online

Start date

Different dates availableEnrolment now open

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Reviews

Subjects

  • Management
  • Education Studies
  • Quality
  • Healthcare
  • Technology
  • Medical
  • Organizational Skills
  • Clinical Studies
  • Health Insurance
  • Knowledge management

Teachers and trainers (1)

Adam Fleming

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

Overview:This presentation, will aid manufacturers of medical devices who intend to modify a 510(k)-cleared device or a preamendments device subject to 510(k)
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

http://www.compliance4all.com/control/w_product/~product_id=502023LIVE?channel=emagister_Aug_2018_SEO

When to Submit a 510(k) for a Change to an Existing Device

£ 229.38 VAT inc.

*Indicative price

Original amount in USD:

$ 290