New Hyde Park, NY, August 07, 2015 --(PR.com
)-- Overview: Manufacturers of Medical Devices are required to report to the FDA when they learn that any of their devices may have caused or contributed to a death or serious injury. Manufacturers must also report to the FDA when they become aware that their device has malfunctioned and would be likely to cause or contribute to a death or serious injury if the malfunction was to be reoccur. The Medical Device Reporting (MDR) regulation (21 CRF 803) contains mandatory requirements for manufacturers, importers, and device user facilities to report certain device-related adverse events and product problems to the FDA.
Importers: Importers are required to report to the FDA and the manufacturer when they learn that one of their components that are used to produce or assemble the final device may have caused or contributed to a death or serious injury. The importer must report only to the manufacturer if their imported devices have malfunctioned and would be likely to cause or contribute to a death or serious injury if the malfunction were to reoccur.
Why Should You Attend:
The FDA expects health care professionals, patients, caregivers and consumers to submit voluntary reports about serious adverse events that may be associated with a medical device, as well as use errors, product quality, and therapeutic failures. The overall intent of this webinar, just like FAA for passenger safety is to provide critical information that helps improve patient safety.
Areas Covered in the Session:
Each manufacturer must establish and maintain procedures to control all documents that are being used for the generation and distribution of medical devices. To meet Quality System guidelines (expectations, regulations, etc.), procedures need to provide but not limited to the following:
1. Medical device reports are submitted to the FDA by mandatory reporters (manufacturers, importers and device user facilities) and voluntary reporters (health care professionals, patients, caregivers and consumers).
(a) Document approval and distribution. Each manufacturer need to designate an individual(s) to review for adequacy and approve prior to issuance the documents generated to meet the requirements of the Quality System generated to be compliant with 21 CRF 820.
2. (b) Document changes. Changes to documents are to be reviewed and in accordance with the implemented Change Control Program. Document changes require notification and related training.
3. Evaluation of suppliers, contractors, and consultants. Each manufacturer is required to establish and maintain the requirements, including quality requirements as well as a quality agreement that must be met by suppliers, contractors, and consultants. Each manufacturer is expected to:
1. Evaluate and select potential suppliers, contractors, and consultants on the basis of their ability to meet specified requirements, including quality requirements. The evaluation must be documented in accordance with cGMP/GDP
2. Define the type and extent of control to be exercised over the product, services, suppliers, contractors, and consultants, based on the evaluation results
3. Establish and maintain records of acceptable suppliers, contractors, and consultants
4. How parties involved in the contract manufacturing of drugs or medical devices can utilize Quality Agreements to delineate their responsibilities and assure product quality, safety, and efficacy.
5. Purchasing data.
6. Identification - 820.60
7. Traceability - 820.65
8. Control of nonconforming product.
10. Each manufacturer is required to maintain a quality system record (QSR) for each batch or lot.
11. Each manufacturer must maintain complaint files.
Device Manufacturers are required to submit certain types of reports for adverse events and product problems to the FDA in a very short time about identified problems with a medical device. If you are a manufacturer, you are considered to have become aware of an event when any of your employees becomes aware of a reportable event that is required to be reported within 30 calendar days or that is required to be reported within 5 work days because the FDA requested reports in accordance with 803.53(b)
Who Will Benefit
• Quality Assurance (QA) Professionals
• Operations Management Professionals
• Medical Device distributors
• Consumers, Patients
• Compliance Officers
• Health Information Managers
• Legal Counsel
• Data and Device Standards experts
• Audit/Inspection coordinators, internal auditors
• IT / IS managers and personnel
• Consultants and Strategists
For more information, please visit http://bit.ly/1MJc2YB
About Compliance Global Inc:
Compliance Global Inc; is a training (webinar) organization based in New Hyde Park, New York, providing world-class compliance trainings and online webinars by leveraging a pool of experienced speakers / consultants in the Pharmaceutical, Bio-Technology, Medical Devices, Clinical Compliance, FDA Compliance, Healthcare, BFSI, Life Science & HR streams for improving the knowledge base of the customers. Our trainings are contemporary, simple and cost-effective with easy access and great delivery experience. Compliance Global is a multifaceted entity, an absolute knowledge repository.
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