It is critical to understand the applicable regulations/requirements and apply them appropriately to each phase of product life cycle. Anyone can read and understand regulations or requirements from the source(s), but when it comes to interpretation and application, they are invisible. This course makes this part of the compliance process visible to participants.
This two days interactive course on medical device regulations will provide a good understating of requirements in US, Canada, Europe, Australia and major Asian countries and how they affect the total lifecycle, especially a company’s products.
After completing this course on medical device regulatory requirements, the attendee will be able to:
- Define a typical Total Product Life Cycle (TPLC) of a medical device from the regulator’s point of view
- Explain each phase of TPLC and manage involved tasks and activities
- Overview of medical device regulations and requirements: United States, Canada, Europe, Australia and major Asian countries
- Identify common elements of regulatory framework based on acquired knowledge
- Develop and determine phases of TPLC of medical devices
- Determine and plug all applicable regulations/requirements to each phase of TPLC
- Apply risk management principles and techniques throughout the TPLC
- Build company-wide Continuous Compliance Culture (CCC) with ease and confidence
Who will benefit:
This interactive course is designed for both technical and non-technical people who are involved in the design, development, manufacturing, marketing, and distribution of medical devices. The people who are involved and responsible for interactions with external partners, hospitals, clinics, healthcare professionals, customers and regulatory authorities will get maximum benefits.
- Senior Management (Director, Associate Director or VP level)
- Sales and Marketing
- Research & Development (R&D)
- Product Design & Development
- Regulatory Affairs Professionals
- Quality Assurance
- Key players in Manufacturing /Production