The FDA must review and process thousands of medical device submissions yearly. Shortening the time to market is a critical consideration of the medical device design and development process only after ensuring and affirming that the device meets its intended use and is safe to patients, consumers, and health professionals.
Regulatory submissions that are poorly structured and organized making information retrieval difficult and that do not meet regulatory requirements, are missing essential information, and demonstrate inconsistencies, extend the time required for approval and essentially extend the ultimate time to market.
This webinar is intended for newer-entry professionals to the medical device industry who require a basic foundational understanding and familiarization of the entire process as a precursor to more advanced instruction concerning the subject.
Why You Should Attend:
More than ever before, medical devices are playing an increasing role in the healthcare of individuals across the world. Some medical devices pose little or no risk to patients while others can be life-sustaining.
Medical devices utilize a variety of technologies to include electronics, mechanics, pneumatics, software, and chemical and/or biological action to achieve their intended function.
Regulatory submissions for medical devices to achieve government approval to market and manufacture varies globally and is as complex a process as the devices themselves.
This webinar will detail the 510K and PMA processes as well as the EU regulation comparing and contrasting those regulations and submissions requirements. No discussion of medical device submissions would be complete without addressing device classifications for both the US and the EU. Properly classifying medical devices is crucial to an effective submissions process.
Finally, this webinar will address quality system certification, product certification and technical files and dossiers.
- 510(k) and PMA processes
- Current EU Regulatory Requirements
- Improving Content and Submission Quality
- CE Marking
- Medical Device Classifications
- IDEs, HUDs
- Quality system certification
- Product certification
- Technical files and dossiers
- Common Pitfalls and How to Prevent Them
- What to Ensure While Preparing for an Application
- Do’s and Don’ts
Who Should Attend:
- Quality Departments
- Regulatory Affairs Departments
- Compliance Departments
- Research and Development Departments
- Clinical Affairs Departments
- Everyone responsible or Interested in the 510(k) Matters