Successful Device Submissions and Approvals - Key Elements


Charles H. Paul is Keynote Speaker at ComplianceKey. He is President of C. H. Paul Consulting, Inc. - a regulatory, training, and technical documentation consulting firm. Charles is a management consultant, instructional designer and regulatory consultant and has led C. H. Paul Consulting, Inc. since its inception over 25 years ago. He regularly consults with Fortune 500 pharmaceutical, medical device, and biotechnology firms assisting them in achieving human resource, regulatory, and operational excellence. He is a regular presenter of webinars and on-site seminars in a variety of related sub........

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 this webinar?

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:

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 can Benefit:



Webinar Id: LSHCCP0013

Training Options:

Duration: 60 mins

 02/15/2019

 10:00 AM PT | 01:00 PM ET

 Single Attendee: [Only for one participant]

$179 (Live)                    $319 (Live + Recorded)

 Multiple Attendee: [For a group of 2-5 participants]

$368 (Live)                    $495 (Live + Recorded)

 Corporate Attendee: [For a group of 6-10 Participants]

$741 (Live)                    $1157 (Live + Recorded)

 Recorded: [Six month unlimited access]

$167 (Single Attendee) $599 (Unlimited Attendee)

Refund Policy
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