Medical devices are a highly diverse group of products, and the processes for their regulatory review and clearance are variable. Lower-risk devices (Class I and II) generally require less time and expense to meet the FDA’s standards for safety and efficacy than Class III devices, but meeting the standards that do exist can be complex.
Developing a high-level strategy for meeting regulatory requirements and implementing a QSR compliant quality system early in a product’s lifecycle can save resources and improve the device’s safety and performance in patients.
Tune in live on Wed., January 28th at 11:30am ET to learn:
- Understanding the classes and corresponding regulatory controls
- Confirming your device’s classification
- Identifying predicate devices already cleared for sale
- Defining your device’s Intended Use
- Developing a regulatory and strategic pathway
Our medical device expert:
Charlotte Baker, RAC, PMP
Senior Director, Regulatory & Strategic Development, Medical Devices, Clinipace Worldwide
Charlotte brings more than 20 years experience in regulatory, quality and compliance in the healthcare, biopharma and medical device industries. She also has a proven track record in leading and achieving successful global product submissions/approvals for new products and post-commercialization changes (PMA & 510k). In her current role, Charlotte is responsible for developing regulatory strategies for client products. She also prepares regulatory submissions for the US FDA, EMEA and other regulatory authorities.
Register today to reserve your spot. Even if you can’t attend the live presentation, register anyway and we’ll send you a link to the recording! Also keep an eye out for an accompanying eBook to follow the webinar.