This webinar sets forth the requirements for 510(k) preparation, targeted for a small to medium-sized company.
A premarket notification submission (510(k)) is required to contain many sections. Each section is proscribed to contain specific information. For a small to medium-sized company, preparation and submission of a 510(k) can be that much more difficult, due to fewer resources, and includes requirements specific to your company’s small to medium size. This webinar sets forth the requirements for 510(k) preparation, targeted for a small to medium-sized company.
Areas Covered in the seminar:
- History of the 510(k).
- When to submit a 510(k)?
- Sections of a 510(k).
- Contents of each section.
- Requirements for small to medium-sized companies.
Who will benefit:
This webinar will provide valuable assistance to all individuals charged with the responsibility for preparing and submitting 510(k). The employees who will benefit include:
- Top Management
- Regulatory Management
- Quality Management
- Regulatory Specialists
- R&D Personnel
- Consultants
Instructor Profile:
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.
