| Live Corporate Webinar : |
Friday : 9th November, 2012
02:00 PM EST | 11:00 AM PST
 |
FDA’s General Controls for Medical Device Manufacturers
|
| Presented by - Sheila J. Ramerman - RAC, Founder, SJR Associates |
| Duration of webinar : 60 Mins | Duration of Q/A session : 10-15 mins |
| Deliverables : Copy of presentation slides will be shared |
| |
| Short
Abstract: |
There are basic requirements (“general controls”) that every medical device manufacturer must meet to legally sell their device in the US. This webcast will outline those general controls, as well as briefly discuss the Medical Device Reporting (MDR) and recall requirements for medical device manufacturers. The emphasis will be on defining what each requirement is, and where to find additional information on the CDRH website.
This presentation will cover the following areas :
- Establishment Registration & Device Listing.
- Adulteration
- Misbranding
- 510(k)
- Records & Reports
- Banned Devices
- Notification & Repair, Replacement or Refund
- Quality System Regulations (QSR)
- Medical Device Reporting (MDR)
- Recalls
|
| Who Should Attend : |
Medical Device companies/professionals including
- Manufacturing
- Regulatory Affairs
- Clinical Affairs
- Quality Professionals
- CROs
- Consultants, Contractors/Subcontractors
- Sales and Marketing
- Senior and Executive Management
- Anyone Interested in Learning More About US FDA Regulations
|
 |
|
|
| Speaker Profile: |
 |
Sheila Ramerman, RAC, is the founder and Principal at SJR Associates, a medical device regulatory affairs/quality systems consulting firm with particular emphasis on near-patient testing technologies and in assisting start-up stage companies implement their regulatory, quality, and clinical studies functions. Prior to founding SJR Associates, Ms. Ramerman was responsible for regulatory affairs, quality systems, and/or clinical studies at several medical device companies in the San Francisco Bay Area. She has hands on experience with several kinds of devices (neurology, clinical laboratory, rehabilitative medicine, orthopedic and arthroscopic surgical devices) and with a range of medical device companies, from start-ups to multi-national corporations. She has successfully submitted over 30 510(k) submissions, and recently was instrumental in achieving PMA approval for a novel radiology software product.
. more...
|
|
|
Best Regards.
Marketing.
|
Follow US on     |
|
