Webinar On Medical Device Reporting - How to establish and maintain adequate procedures

This webinar is intended to help you avoid FDA 483s and warning letters for failure to establish and maintain adequate procedures for medical device reporting.

Device manufacturers are required to establish and maintain medical device reporting procedures pursuant to the FDA regulations.

Areas Covered in the Session :

Applicable Statues and Regulations

Definitions

MDR Regulatory Requirements

MDR Standard Operating Procedures (SOPs): Required Elements

MDR Criteria

Determining and Reporting MDR Events

Reporting Requirements for the User Facilities, Manufacturers, and Importers

Integrating Unique Device Identification (UDI)

Enforcements:  Case Studies

Common Mistakes and Consequences

Best Practices

Speaker’s PASS-IT Solutions

Who Will Benefit:

A must webinar for all personnel in:

Clinical Affairs

Regulatory Affairs

Quality

Research & Development

Complaint and Risk Management

Consultants

Senior Management

Contractors/subcontractors

Other interested parties

Price Tags:

Live

Single Live : For One Participant

$ 249

Corporate Live : For Max. 10 Participants

$ 899

Recording

Single REC : For One Participant - Unlimited Access for 6 Months

$ 299