- Are you struggling with the implementation and maintenance of your medical device Quality System?
- Would you like to ensure that your company operates an effective QSR and Rad Health program which meets or exceeds regulatory expectations and industry best practice standards?
- Are your employees trained to critically identify and assess the impact new products and services will have on their overall risk assessment?
- Is your company aware of its regulatory obligations and the potential impact of non-compliance?
This highly interactive seminar will provide answers to all these questions. Many medical laser manufacturers have failed to capture regulatory requirements for the embedded laser, UV or X-Ray components within their devices, leading to serious regulatory non-compliance issues. It would be prudent to ensure your organization’s compliance program is effective and is tailored to all applicable FDA and ISO regulatory standards prior to distribution, or finding out what possible current regulatory non-compliance issues are key risk factors within your organization’s devices.
This course on medical device QSR will provide an overview of the importance of establishing, implementing and maintaining a product specific compliance program capturing all relevant topics. The attendees will learn about the risk based approach and the essential elements of an effective risk assessment in the design and development of medical and combination medical devices. Attendees will be provided with all the tools necessary to ensure their present medical devices or planned devices meet or exceed required FDA and ISO regulations. The instructor will explain testing techniques which would assist in improving a company’s overall quality system program. Enforcement actions case studies will be reviewed as part of the course and the instructor will discuss how the same could have been prevented. It will also review key internal controls that can help prevent missing out on key requirements.
Key goals of this course are:
- To provide an understanding of the key elements of a medical device Quality System under FDA regulations 21 CFR 820 and ISO 13485
- Provide an understanding of the Radiation Health Performance Standards as they apply specifically to laser/UV medical and industrial devices and short discussions on X-Ray contained devices.
- To meet/exceed regulatory expectations and to ensure the organization is prepared to manage requirements of both converging regulations
- To understand reporting requirements for medical devices containing radiation emitting devices.
- The course will focus on the following key aspects of a medical device Quality System:
- Management requirements for establishing a Quality System
- Design controls and design change controls
- CAPA and non-conformance regulations and monitoring
- Complaint handling procedures
- Adverse event reporting (MDR and vigilance)
- Production and process controls
- Recall and market withdrawal
- Document control
- The course will also discuss the Radiation Emitting Performance Standards as they refer to medical devices
- 21 CFR 1040.10 & 1040.11- laser and UV performance standards
- 21 CFR 1002- reporting requirements for all radiation emitting devices
- 21 CFR 1003; 1004 and 1005, the regulations most costly to non-compliant radiation emitting device manufacturers
- To review the key requirements to ensure your combination product meets or exceeds current regulations.
Who Will Benefit:
- Medical device manufacturers with or without radiation emitting device
- Internal Auditors
- Legal Departments
- Compliance Officers
- Program Managers