Post Learning Implementation Plan (PLIP)

Pre-course

• Access to the Educo Training Portal
• Submit your needs analysis and objectives for training by completing a simple online form

Action Plan

• At the end of the training you will create an action plan to help you implement and develop your new skills and knowledge

Reinforcement Session

• Delivered 3 to 4 weeks after the training
• It is a 1 hour virtual session enabling the group to reinforce the key learnings from the training and cover and subsequent questions and challenges

Introductory Online Module

FREE to Attend | Live & Recorded

13 February 2025 | 60 mins | 1:00 PM (UK)

Overview of US FDA Medical Devices and IVDs

• Definitions of product types
• Introduction to the various regulatory pathways for the following:
  • Traditional Medical Device
  • IVDs
  • Combination Devices

Register For Module 1 | Free

There are limited spaces on module 1. If demand is high you may not be able to attend the live session, however you will be sent the recording. Priority is given to full registrations.

Module 2

17 March 2025 | 180 mins | 1:00 PM (UK)

Assessing the FDA Regulatory system

• Code of Federal Regulations (CFRs) and the fundamentals of US regulations
• Interaction pre-market with FDA
• 513(g) classification request
  • Understand the US FDA device classification system
• Q submission requests

Module 3

18 March 2025 | 180 mins | 1:00 PM (UK)

Regulatory strategies for placing devices to market – part 1

• In this session, you will review the 510(k) and 510(k) exempt regulatory pathways.
• 510(k) exempt
  • Understand what devices are exempt
  • Review the FDA process
  • Examine case study examples
• 510(k)
  • Assess the regulatory process and when a 510(k) is required
  • Examine the information required for a successful 510(k) application
  • Review substantial equivalence
  • Understand the review process

Module 4

19 March 2025 | 180 mins | 1:00 PM (UK)

Regulatory strategies for placing devices to market – part 2

• In this session, you will review the regulatory pathways for De Novo devices and the PMA process.
• De Novo – classifying innovative medical devices that are not on the predicate device database
  • Review the risk bases approach to classification
• Premarket Approval (PMA)
  • Understand when a PMA is required
  • What data requirements you must submit?

Module 5

20 March 2025 | 180 mins | 1:00 PM (UK)

Maintaining and keeping your device on the US market

• Quality Management System Regulation
• Device Listing and Registration
• Medical Device Reporting
• Post Market Surveillance/life cycle management

Kathleen Harris has over 30 years of experience in the Life Science and Pharmaceutical industries including as a regulator (USFDA).   With degrees in Biology, Chemistry, and advanced degrees in Statistical Processes and Emerging Market Economics, she went to work for Bard Pharmaceuticals and Cook Biotech before working for the US Food and Drug Administration.  Kathleen has since worked as Sr. Vice President of Regulatory and Quality for large multinational organizations.  She started 2Harris consulting in 2014,  offering comprehensive global regulatory strategies, ensuring seamless global product registration, and maintaining stringent quality compliance.   Kathleen is a member of RAPS, ABHI,  CLSI Standards Committee, AAMI, AvaMed and ACDI/VOCA.

Specialities include:

• Global regulatory strategies and quality management systems that meet international requirements.
• Premarket/product development regulatory strategy
• International and National product registrations: USA, EU, Japan, Canada, Brazil, Australia, United Kingdom
• Gap analysis compliance audits for manufacturers: MDSAP, FDA, Pharmacovigilance, ISO 13485
• Compliance training and coaching