How to Prepare a FDA 510(k) submission - By AtoZ Compliance

Tuesday, Apr 25, 2017 at 1:00PM - 2:00PM
New Hyde Park, NY

Event Details

Key Take Away :

This webinar will explain what the FDA 510(k) guidance is and the procedure to prepare the submission, the several types of 510(k), each part of the premarket notification – 510(k)submission including the very confusing concepts of predicate device and substantial equivalence.

Overview :

Understand FDA 510(k) process for medical devices. How to find an acceptable predicate device will be taught. FDA places special emphasis on device software. We will cover the FDA regulations for medical devices software.

Why Should You Attend :

Preparing a submission to get FDA approval for a new product is time consuming and confusing. The submission requirements refer to many unfamiliar concepts and terms such as predicate device and substantial equivalence. More than half of all submissions are rejected. We will teach you to prepare a submission meeting all the FDA requirements.

Areas Covered In This Webinar :

510(k) unique terminology
Refuse to accept policy

Learning Objectives :

Learn how to submit a FDA 510(k) application
What is a predicate device?
Selecting a predicate device (substantial equivalence)
Where to find substantially equivalent predicate devices
How to handle software

Who Will Benefit :

Regulatory affairs (associates, specialists, managers, directors or VPs)
Quality professionals (associates, specialists, managers, directors or VPs)
R&D (engineers, scientists, managers, directors or VPs)
Risk management personnel
Operations Personnel (Medical/Pharma/Biotech)
Quality/Regulatory/Compliance Consultants
Validation/Verification/Documentation/Product/Process/Project (Mfg)
Clinical affairs (associates, specialists, managers, directors or VPs)
Engineering Personnel (Quality/Regulatory/Compliance)
Software Developers (Medical/Pharma/Biotech)

For more information, please visit : https://www.atozcompliance.com/trainings-webinar/life-sciences/medical-devices/fda-510k-approval-process-for-medical-devices/edwin-waldbusser/300207?utm_source=ref&utm_medium=25Apr
Email: support@atozcompliance.com 
Toll Free: +1- 844-414-1400
Tel: +1-516-900-5509


Speakers Profile :

Edwin Waldbusser
Edwin Waldbusser retired from industry after 30 years in management of development of medical device products and development of company Quality Systems. Products included IVD devices, kidney dialysis systems and inhalation devices. 

His QS experience includes design control, risk analysis, CAPA, software validation, supplier qualification/control and manufacturing/non-conforming product programs.

Ed has a B.S. Mechanical Engineering from NYU and a M.B.A from Drexel University. He is certified by Lloyds of London as an ISO 9000 Lead Auditor and is a member of the Thomson Reuters Expert Witness network. He has 5 issued patents.

Organization Details

AtoZ Compliance; is an online compliance webinar training organization based in New Hyde Park, New York. We provide diverse range of quality webinar training programs to all the major segments of industries.

Our compliance webinar training programs are designed to meet the changing compliance requirements and we have been successful in conducting high quality training programs to professionals from Fortune 500 to large and medium organizations.

We cater to all major industries where FDA regulations and compliance adherence has been extremely critical in the business decision making process. Our compliance webinar training programs focuses on industries such as Life Sciences, Food and Chemicals,Human Resources, Banking and Financial Services,Healthcare and varied other Cross Industry streams.

We take extreme care in selecting the topics which are highly relevant to all the industries and are capable of meeting the demands of the complex compliance environment. Our great pool of experienced speakers ensures that your business is up to date with the most relevant and accurate compliance information.

At AtoZ Compliance, we focus on our core values - quality, expertise, and customer experience which are the foundation of our business. We believe that our compliance webinar training programs based on our value system can help you grow and succeed in your business.

AtoZ Compliance. 2754 80th Avenue
New Hyde Park, NY 11040

Starts April 25, 2017 at 1:00PM - 2:00PM

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Contact Information

Organization: AtoZ Compliance

Event Contact: AtoZ Compliance

Phone: 5169005509

Organization Web Site: