510(k) Update - How to Format Succinct and Comprehensive 510(k)s 2019 provides knowledge on what to consider and how to prepare for premarket notification 510(k)s and submit to the FDA.
510(k) Update - How to Format Succinct and Comprehensive 510(k)s 2019 covers topics such as:
- Overview of 510(k) Program and Changes
- Laws, Regulations and Definition
- Review of Relevant and Applicable Guidance Documents and Standards
- 510(k) Regulatory Requirements
- Quality System Regulations
- Systematic Methods to Increase 510(k) Submission Quality
- 510(k) Contents
- How to Format a Succinct and Comprehensive 510(k) Submission
- What to Ensure While Preparing for a 510(k) Application
- Common Pitfalls and How to Prevent Them: Dos and Don’ts
- Resolving Different Opinions and Interpretations: Dos and Don’ts
- Responding to FDA’s Request of Additional Information
510(k) Update - How to Format Succinct and Comprehensive 510(k)s 2019 brings together attendees from:
- Medical Devices Quality Departments
- Pharmaceutical Quality Departments
- Pharmaceutical Compliance Departments
- Regulatory Affairs Departments
- CEOs
- Medical Devices Compliance Departments
- Attorneys
- VPs
- R&D Departments
- Clinical Affairs Departments
- Contractors/Subcontractors
- Consultants
- Everyone responsible or Interested in the 510(k) Matters