ComplianceOnline

Successful Device Submissions and Approvals - Key Elements

Instructor: Charles H Paul
Product ID: 704813
  • Duration: 60 Min
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This Training will describe the basic requirements for medical device submissions. The topic will spotlight the differences and focus upon the required quality system elements that must be addressed. It will provide an overview of the FDA premarket and EU Medical Device Directives submissions processes and discuss how devices are classified.

Why Should You Attend:

It is imperative that a unified regulatory strategy be 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 upon the required quality system elements that must be addressed. It provide an overview of the FDA premarket and EU Medical Device Directives submissions processes and discuss how devices are classified.

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

Areas Covered in the Webinar:

  • Medical device classifications
  • 510(k) and PMA
  • Current EU Directives
  • Intended use
  • Indications for use
  • IDEs, HUDs
  • Quality system certification
  • Product certification
  • Technical files and design dossiers

Who Will Benefit:

This webinar will provide valuable assistance to all personnel in:

  • Engineering
  • Manufacturing
  • Quality Assurance
  • Regulatory submissions
  • R&D personnel
  • Documentation

Instructor Profile:

Charles H. Paul is the 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 subjects from documentation development to establishing compliant preventive maintenance systems.

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