Course Description:

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.

Learning Objectives:

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

  1. What is a typical Total Product Life Cycle (TPLC) of a medical device
  2. Understand activities of each phase of TPLC
  3. 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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How to Reach

General Driving Directions:

Driving Directions from Boston Logan International Airport – BOS: 3.2 mile(s) NE
  • Follow signs for Boston/Sumner tunnel.
  • Pay the toll and stay in the right lane in the tunnel.
  • Follow signs for Exit 26/Storrow Drive. After you emerge from the tunnel, take the second left exit to Copley Square/Back Bay.
  • At the first light, turn right onto Beacon St. Follow Beacon St. for 4 blocks and make a left on to Exeter St.
  • After 5 lights, Exeter St. ends at Huntington Ave. Turn right onto Huntington Ave.
  • At the first light, under the sky bridge, make a U-turn to the left. The hotel entrance will be immediately on your right.

Other Transportation:

Bus Station
  • South Station: 1.2 mile(s) E

Subway Station
  • Back Bay Station: 0.2 mile(s) E

Train Station
  • Back Bay / Copley Station: 0.2 mile(s) E
  • North Station: 2 mile(s) NE

Disclaimer: Directions to the venue above have been taken from the hotel website. Attendees are advised to check with the hotel for confirmation of these directions before starting for the venue. ComplianceOnline is not responsible for any inaccuracies in the same.

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