When to Submit a 510(k) for a Change to an Existing Device
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Training by
Compliance4All
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On-Site
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USD 290.00
Details
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 Managers
Quality Engineers
Regulatory Affairs
Small 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: +1-800-447-9407
Email: [email protected]
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 Managers
Quality Engineers
Regulatory Affairs
Small 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: +1-800-447-9407
Email: [email protected]
Outline
Special Offer
One Dial-in One Attendee
Price: $290.00
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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. Compliance4All offers path breaking professional training solutions to organizations that help them address pain areas and overcome the challenges and difficulties associated with meeting 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. Compliance4All offers path breaking professional training solutions to organizations that help them address pain areas and overcome the challenges and difficulties associated with meeting regulatory requirements.
