Successful Device Submissions and Approvals - Key Elements
Instructor:
Charles H Paul
Product ID: 704813
- Duration: 60 Min
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
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.
Refund Policy
Our refund policy is governed by individual products and services refund policy mentioned against each of offerings. However in absence of specific refund policy of an offering below refund policy will be effective.
Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange. Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time. On-Demand Recording purchases will not be refunded as it is available for immediate streaming. However if you are not able to view the webinar or you have any concern about the content of the webinar please contact us at below email or by call mentioning your feedback for resolution of the matter. We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email [email protected] call +1-888-717-2436 (Toll Free).
