ISO 13485 Made Easy
Instructor:
Jeff Kasoff
Product ID: 700786
- Duration: 60 Min
Development, implementation, and maintenance of an ISO 13485-compliant quality management system requires many resources and personnel to meet with success. This webinar reviews the requirements of ISO 13485 in a straightforward manner, and includes suggestions for development of a compliant system.
Areas Covered in the seminar:
- The purpose of the standard
- Standard structure
- Requirements
- Implementation approach
Who will benefit:
This webinar will provide valuable assistance to all device manufacturers who wish to have a better understanding of the requirements of ISO 13485. The employees who will benefit include:
- Top Management
- Regulatory Management
- Quality Management
- Documentation Managers
- Quality Engineers
- Other personnel involved in development and implementation of the QMS
Jeff Kasoff, RAC, is the Director of Regulatory Affairs at Life-Tech, Inc., a leading manufacturer of consumables and instrumentation in the urodynamic and pain management fields. Jeff is responsible for oversight of corporate compliance with domestic and international regulations, preparation of submissions, and is primary liaison with regulatory agencies and notified bodies. Jeff began his regulatory career as the first full-time employee of Optex Biomedical, a device start-up, where he initiated their regulatory policies and procedures and prepared their submissions. Jeff received his Regulatory Affairs Certification in 1996.
More Training By Experts
- Supplier Management: Challenges and Opportunities
- Document Approval, Control, and Distribution: How to Meet FDA QSR and ISO 13485 Requirements
- The FDA Inspection Process: From SOP to 483
- Supplier Evaluation and Internal Auditing for FDA and ISO 13485 Compliance: Pack of Three Courses
- Training Requirements and Practices to Assure QSR and ISO Compliance
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).
