Aug, 14

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

Tuesday, Aug, 14, 2018 From 09:00 AM to 12:00 PM

LOCATION
Fremont, CA, USA

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* Note : This is a public Event.

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

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: support@compliance4All.com

http://www.compliance4all.com/control/w_product/~product_id=502023LIVE?channel=attune_Aug_2018_SEO

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Fremont, CA, USA

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2018-08-14 09:00:00 2018-08-14 12:00:00 When to Submit a 510k for a Change to an Existing Device

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: support@compliance4All.com

http://www.compliance4all.com/control/w_product/~product_id=502023LIVE?channel=attune_Aug_2018_SEO

Fremont, CA, USA Compliance4All DBA NetZealous support@compliance4All.com
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