Medical device manufacturers are not only self-regulated, but are also regulated by numerous local and national governmental agencies.
As such, medical device manufacturers are regulated by various laws, regulations, standards, and guidelines written and adopted by industry and governmental agencies.
Medical device regulations in the US and the EU are foundational to the remainder of the regulations that are applied to medical devices throughout the world.
An inspection by a representative of a regulatory body or a complaint from the market could uncover regulatory violations that may result in sanctions of various levels of seriousness.
These sanctions could result in diminished reputation, device recalls, extended intrusive monitoring, and/or civil and criminal penalties.
This webinar will provide basic information concerning the structure of both US and EU regulatory bodies. The regulatory content common to all regulations will be addressed to create a foundation for understanding the basics of medical device compliance regulations.
We will then discuss the meaning of regulatory compliance from both an internal - company, and external - regulatory body standpoint.
To establish clarity and common understanding, we will discuss and define the differences between the common regulatory terms - law, regulation, directive, standard, and guideline and explore their impact upon compliance.
21CFR 820 the Quality System Regulation is an essential part of the entire medical device regulatory portfolio and is critical to any discussion of medical device regulations. We will discuss the key components of this regulation and how the regulation relates to the “Total Quality System Concept.”
We will complete the webinar with a discussion of the EU Medical Device Directives and how they compare to the new Medical Device Regulation.
Why Should You Attend?
It is important to understand how regulatory agencies in both the US and the EU are structured and function and the specific medical device regulations within each jurisdiction that apply to maintain sound medical device compliance.
Today, with the EU’s new Medical Device Regulation of over 400 pages soon to be law and the complexities of medical device regulations in the US, it is critical to effective regulatory compliance that all levels of management all along the supply chain, understand how the process works and have at least a basic understanding of the key regulations and their contents.
C. H. Paul Consulting, Inc.
Charles H. Paul is the President of C. H. Paul Consulting, Inc. - a regulatory, Lean Manufacturing, training, and technical documentation consulting firm.
Charles is a management consultant, instructional designer and regulatory consultant and has led C. H. Paul Consulting, Inc. since its inception over 25 years ago. He regularly consults with Fortune 500 pharmaceutical, medical device, and biotechnology firms assisting them in achieving human resource, regulatory, and operational excellence.
He is a regular presenter of webinars and on-site seminars in a variety of related subjects from documentation development to establishing compliant preventive maintenance systems. The firm works globally completing projects throughout the EU, UK, South America, and Asia.