Specifically, this webinar will discuss special controls in detail including:

• What are special controls? When and how are they used?

• Why do we call them “special” controls? Are they really “special?”

• What’s the difference between general controls and special controls? When and why do we need both?

• How do you know if your device requires special controls? How can you find out?

• For Class II exempt devices, do special controls still apply?

• How do special controls vary in a 510(k) vs. in a de novo?

• Virtually all special controls are intended to ensure safety, but can special controls address efficacy?

• When should an existing standard for a special control be used vs. when to create a new standard?

Using the case study approach, regulatory expert Michael Drues, Ph.D., President of Vascular Sciences, will present detailed explanations to all of the above questions and more during this interactive webinar.
If you're working on a medical device involving special controls – and you probably are – you won’t want to miss this important webinar!

Who Should Attend?

Geared for both experienced medical device professionals as well as those new to the industry, this webinar is designed for those who need a better understanding of the regulatory requirements necessary to bring medical devices to market.

Personnel working in the following disciplines will find this course particularly useful:

• Regulatory Affairs Professionals

• QA/QC Personnel

• Design and Development Engineers and Technicians

• Product and Product Development Management

• Medical Device Executives

• Scientists

Additionally, investment/ acquisition specialists and field service engineers will all benefit from this webinar.