How to prepare a 510(k) Notification and a Technical File for the CE Mark 2017 is a course that covers topics such as:
- Technical File
- Determine Device Classification and Conformity Assessment Procedure
- Formatting a Technical File
- Clinical Evaluation Report Requirements
- Essential Requirements Checklist Requirements
- Contents of a Declaration of Conformity
- Risk Management Plan and Reports Requirements
- Key changes in the new Medical Device Directive
- 510(k) Notifications
- When to file for a new device, a change in the intended use or a change in the technology of a cleared device
- Difference between a traditional, abbreviated and special 510(k) and when to submit each type of 510(k)
- What is substantial equivalence and what`s required to show substantial equivalence
- What is contained in a traditional, abbreviated and special 510(k) submission package
- Which performance tests should be conducted and how to present the data to the FDA
- What`s required on the labeling and IFU
- What is required in a submission for software controlled devices
- Understand the FDA`s Refuse to Accept Policy
How to prepare a 510(k) Notification and a Technical File for the CE Mark 2017 brings together:
- Regulatory Affairs Managers
- Company CEOs and Presidents
- Regulatory and Quality Assurance Professionals
- Quality Assurance Managers
- Quality Engineers
- Design Engineers
- Legal Professionals
