Why should you Attend
It's routine practice for Sales to identify a market opportunity, and require market penetration ASAP. If your company lacks personnel who are experienced in the requirements and nuances of 510(k) preparation, this market opportunity could wither on the vine. Repeated occurrences of such lack of 510(k) knowledge may very well have a negative impact of corporate solvency.
Areas Covered in the Session
- When to submit a 510(k) for a new or modified product
- Types of 510(k) submissions and when to use each
- What is the submission process
- What is contained in a 510(k) submission package
- How to know whether clinical data is required
- How is the submission package assembled
- User fees and 510(k) submissions
- How to interact with the FDA and the reviewer
- What do to if you make a change to your device
Who will benefit: (Titles)
This webinar will provide valuable assistance to all medical device companies that prepare 510(k) submissions. The employees who will benefit include:
- Executive Management
- Regulatory management
- Professionals involved with premarket notification to FDA
- R&D personnel involved in approving the design of medical devices
- Sales personnel involved in approving the marketing of medical devices
It's routine practice for Sales to identify a market opportunity, and require market penetration ASAP. If your company lacks personnel who are experienced in the requirements and nuances of 510(k) preparation, this market opportunity could wither on the vine. Repeated occurrences of such lack of 510(k) knowledge may very well have a negative impact of corporate solvency.
Areas Covered in the Session
- When to submit a 510(k) for a new or modified product
- Types of 510(k) submissions and when to use each
- What is the submission process
- What is contained in a 510(k) submission package
- How to know whether clinical data is required
- How is the submission package assembled
- User fees and 510(k) submissions
- How to interact with the FDA and the reviewer
- What do to if you make a change to your device
Who will benefit: (Titles)
This webinar will provide valuable assistance to all medical device companies that prepare 510(k) submissions. The employees who will benefit include:
- Executive Management
- Regulatory management
- Professionals involved with premarket notification to FDA
- R&D personnel involved in approving the design of medical devices
- Sales personnel involved in approving the marketing of medical devices
