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

Module 1

Using the regulations and definitions to determine if your product is a device

• Medical device definitions
• In-vitro diagnostic software
• Multi-functionality software
• Cloud computing and software as a service
• Intended purpose and excluded functionality
• Companion diagnostics, medication management and adherence apps
• Population health and educational software
• Resource and workflow management vs clinical decision support software
• Clinical decision software

Module 2

Software classification

• Implementing the classification rules on software
• Software that drives or influences the use of a (hardware) medical
  device
• Borderline with lifestyle and fitness software
• Borderline with pharmaceuticals, combination products
• IMDRF SaMD risk type determination

Module 3

Placing a medical device software in the EU market

Examine the regulatory requirements to put a medical device software on the European market. You will examine the Medical Device Regulation (MDR).

• Engaging with a Notified Body
• Controlling software suppliers and subcontractors
• UDI number and EUDAMED
• Declaration of Conformity
• Person responsible for regulatory compliance (PRRC)
• Software traceability
• App stores and digital distribution platforms

Module 4

Placing a medical device software in the US market

Examine the regulatory requirements to put a medical device software on the market. You will examine the 510(k) process and various FDA software guidances

• US Code of Federal Regulations and its’ implications for software
• 510(k) process
• FDA guidance for software
• Practical construction of a 510(k)
• Challenges faced for app developers to have their app taken up in care pathways
• Quality and reliability of health and wellness apps
• Evolving policy and reimbursement landscapes for digital health technologies

Module 5

Clinical evaluations

• Defining a scope and a sufficient level of clinical evidence for medical device software
• Role of validation and usability
• Considerations for artificial intelligence and continuous learning software

Module 6

Clinical investigations

• General principles of clinical investigations
• When is a clinical investigation needed for medical device software
• Selecting appropriate study design
• Clinical performance studies
• Generating evidence of effectiveness

Module 7

Safety risk management – ISO 14971

• Applying an effective risk management strategy for medical device software

Module 8

Post-Market Surveillance for medical device software

• Post-market regulatory requirements
• Components of an effective PMS
• Process interface with CAPA, NC, vigilance, service, periodic safety updates, trend reporting
• Implementation of Post Market Clinical Follow-up for medical device software
• Real-world evidence
• Successfully bringing together risk management, clinical evaluation and PMS to streamline ways of working

TBC