Successful Device Submissions and Approvals - Key Elements

This webinar will address those specific aspects of the regulatory climate that must be properly applied and addressed to achieve a successful submission and approval, Also provides an overview of the FDA premarket and EU Medical Device Directives submissions processes and discusses how devices are classified.

Charles H. Paul
Instructor:
Charles H. Paul
Date:
Wednesday, April 3, 2019
Time:
10:00 AM PDT | 01:00 PM EDT
Duration:
60 Minutes

More Trainings by this Expert   Product Id : 502431

Price Details
$150 Live
$290 Corporate Live
$190 Recorded
$390 Corporate Recorded
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Overview:

The medical device market is the largest market of all of the life sciences and it is generally valued at upwards of $90 billion with the expectation of continuous growth. This growth demands that the market is continually fed with new and innovative products.

Regulation, here in the US as well as in the EU have made the approval of products for market a complex process requiring manufacturers, to ensure their own survival, to be fully knowledgeable of the regulatory submissions process. It is imperative that a unified regulatory strategy is established by manufacturers to ensure that their designed and developed medical devices are approved for their target markets.

This webinar will address those specific aspects of the regulatory climate that must be properly applied and addressed to achieve a successful submission and approval. These keys to regulatory success will be identified and explored.

Requirements for submissions and approvals differ from country to country however the core submissions requirements are very similar.

This webinar will also spotlight this differences and focus upon the required quality system elements that must be addressed, provide an overview of the FDA premarket and EU Medical Device submissions processes, and discuss how devices are classified.

Why should you Attend: It is imperative that a unified regulatory strategy is established by manufacturers to ensure that their designed and developed medical devices are approved for their target markets.

This webinar will address those specific aspects of the regulatory climate that must be properly applied and addressed to achieve a successful submission and approval.

Requirements for submissions and approvals differ from country to country however the core submissions requirements are very similar.

This webinar will spotlight the differences and focus on the required quality system elements that must be addressed. It provides an overview of the FDA premarket and EU Medical Device Directives submissions processes and discusses how devices are classified.

Areas Covered in the Session:

  • Medical device classifications
  • 510(k) and PMA
  • Current EU Directive
  • Intended use
  • Indications for use
  • IDEs, HUDs
  • Quality system certification

Learning Objectives:
  • Describe the basic requirements for medical device submissions
  • Explain how medical devices are classified
  • State the FDA 510K classification and documentation requirements for medical devices
  • State the European Medical Device Directives requirements to ensure that devices meet minimum safety and quality standards
  • Explain and discuss the PMA
  • State the requirements for design validation
  • Explain the purpose of technical files and product dossiers for CE Mark submission and approval

Who Will Benefit:
  • Engineering
  • Quality Assurance
  • Regulatory submissions
  • Research & Development


Speaker Profile
Charles H. Paul is the President of C. H. Paul Consulting, Inc. - a regulatory, manufacturing, training, and technical documentation consulting firm - celebrating its twentieth year in business in 2017. He has been a regulatory and management consultant and an Instructional Technologist for 30 years and has published numerous white papers on various regulatory and training subjects. The firm works with both domestic and international clients designing solutions for complex training and documentation issues.

He has held senior positions in consulting and in corporate training development prior to forming C. H. Paul Consulting, Inc. He also worked for several years in government contracting managing the development of significant Army-wide training development contracts impacting virtually all of the active Army and changing the training paradigm throughout the military.

He has dedicated his entire professional career explaining the benefits of performance-based training




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