Implication of Global Medical Device Regulatory Requirements to Total Product Life Cycle: Practical Approach - from Concept to Market and Beyond
Subhash R Patel, Regulatory Affairs & Quality Compliance Consultant at MD Reg Consulting, LLC
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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
|Day One (8:30 AM – 4:30 PM)
||Day Two (8:30 AM – 4:30 PM)
Registration Process: 8:30 AM – 9:00 AM
Session Start Time: 9:00 AM
Welcome and Introduction
Session 1: 09:00 AM – 10:30 AM
Total Product Life Cycle
- What is a typical Total Product Life Cycle (TPLC) of a medical device
- Understand activities of each phase of TPLC
- Why TPLC is important to you and your company’s product
Morning Break: 10:30 AM – 10:45 AM
Session 2: 10:45 AM – 12:15 PM
An overview of applicable U.S. medical device regulatory requirements to TPLC
Lunch Break: 12:15 PM – 1:15 PM
Session 3: 1:15 PM – 2:45 PM
An overview of applicable Canadian medical device regulatory requirements to TPLC
Afternoon Break: 02:45 PM – 03:00 PM
Session 4: 03:00 PM – 04:30 PM
An overview of applicable European medical device regulatory requirements to TPLC
Session 5: 8:30 AM – 10:30 AM
An Overview of applicable Australian medical device regulatory requirements to TPLC
Morning Break: 10:30 AM – 10:45 AM
Session 6: 10:45 AM – 12:15 PM
An overview of applicable select major Asian countries’ medical device regulatory requirements to TPLC
Lunch Break: 12:15 PM – 1:15 PM
Session 7: 1:15 PM – 2:45 PM
Mapping global regulations and regulatory requirements to each phase
Afternoon Break: 02:45 PM – 03:00 PM
Session 8: 03:00 PM – 04:30 PM
Exercise: Mapping applicable medical device regulations and requirements to your product(s)
Questions & answers (if any)
Meet Your Instructor
||Subhash R Patel
Regulatory Affairs & Quality Compliance Consultant at MD Reg Consulting, LLC
Subhash Patel is a seasoned and well-accomplished Regulatory Affairs and Quality professional with over 27 years of Global Regulatory Affairs experience in highly regulated medical device industry. Mr. Patel is a founder and owner of MD Reg Consulting, LLC offering services to medical device industry clients. He started his career as a Quality Engineer and climbed corporate ladder to the Director of Corporate Regulatory Affairs/QA of Fortune 500 medical device companies. During his professional journey he gathered wealth of practical knowledge and working experience with the global laws, regulations, and regulatory requirements for medical devices. His passion is to learn new challenges and share his knowledge and experience with others to succeed.
He is Regulatory Affairs Certified (RAC) and also honored as a RAPS Fellow by the Regulatory Affairs Professional Society (RAPS). He holds professional certificates in Medical Devices Regulatory Affairs Program, ASQ-Certified Quality Auditor (CQA) and ASQ-Certified Quality Engineer (CQE). His educational background includes BS degree in Mechanical Engineering and also BS degree in Chemistry.
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