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Introduction to FDA & EU Medical Device Submissions
- 510(k) and PMA Processes
- Current EU Directives/Regulation
- Medical Device Classifications
- IDEs, HUDs
- Quality System Certification
- Product Certification
- Technical Files and Dossiers
Overview of the webinar
More than ever before, medical devices are playing an increasing role in the healthcare of individuals across the world. Some medical devices pose little or no risk to patients while others can be life-sustaining. Medical devices utilize a variety of technologies to include electronics, mechanics, pneumatics, software and chemical and/or biological action to achieve their intended function. Regulatory submissions for medical devices to achieve government approval to market and manufacture varies globally and is as complex a process as the devices themselves.
This webinar will detail the 510(k) and PMA processes as well as the EU directives comparing and contrasting those regulations and submissions requirements. No discussion of medical device submissions would be complete without addressing device classifications for both the US and the EU. Properly classifying medical devices is crucial to an effective submissions process. Finally, this webinar will address quality system certification, product certification and technical files and dossiers.
Who should attend?
- Engineers
- Managers
- Supervisors
- Scientists
- Technicians
- Personnel involved in Product Development, Manufacturing, Quality Assurance or Regulatory Affairs that require a basic understanding of the regulatory submissions process
Why should you attend?
The FDA must review and process thousands of medical device submissions yearly. Shortening the time to market is a critical consideration of the medical device design and development process only after ensuring and affirming that the device meets its intended use and is safe to patients, consumers and health professionals. Regulatory submissions that are poorly structured and organized making information retrieval difficult and that do not meet regulatory requirements, are missing essential information, and demonstrate inconsistencies, extend the time required for approval and essentially extend the ultimate time to market.
This webinar is intended for newer-entry professionals to the medical device industry who require a basic foundational understanding and familiarization of the entire process as a precursor to more advanced instruction concerning the subject.
Faculty - Mr.Charles H. Paul
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.