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Medical Software

CPMS® Certified Professional for Medical Software — Foundation Level

Gain an overview of medical software's regulatory landscape, special requirements, quality management processes and associated document and risk management processes.

The internationally recognized certification for Certified Professional for Medical Software — Foundation Level (CPMS®) pursues the goal of creating a uniform, recognized level of training for professional developers of medical software. The knowledge imparted in this context can help participants save costs in software development and avoid superfluous work steps.

This training provides an overview of quality management and the associated document and risk management; regulatory requirements; and special requirements of medical software.

Duration

3 days

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Key Takeaways

Regulatory landscape

  •   Legal foundations
  •   The European regulations
  •   The harmonized standards
  •   Controls
  •   Regulations outside the EU

Medical informatics

  •   Informatics in healthcare 
  •   Interoperability

Risk management

  •   Introduction to risk management 
  •   The risk management process according to ISO 14971
  •   Risk analysis process

IT security

  •   General requirements
  •   Process requirements
  •   Requirements for the product

Software engineering and IEC 62304

  •   Software development process
  •   Development planning
  •   Software requirements analysis
  •   Software architecture
  •   Software design
  •   Software implementation
  •   Software integration
  •   Software testing
  •   Software release
  •   Software configuration management
  •   Software maintenance
  •   Software problem solving
  •   Software of unknown provenance (SOUP)

Usability

  •   Basics usability
  •   Regulatory requirements
  •   Requirements of IEC 62366−1
  •   From context of use to requirements of use
  •   User interface
  •   Methods of evaluation
  •   Documentation

Quality and document management

  •   Quality management
  •   General requirements for documentation
  •   Required documentation

Target Audience

The training is aimed at all those interested in the topic of development and quality assurance of software in medicine. It is particularly interesting for people working in the following areas:

  • Software design, development and architecture for medical software
  • System analysis
  • Project management, quality management, project management, product management and regulatory affairs management
  • Authorities with a supervisory function (regional councils, trade supervisory offices)

Prerequisites

No precertification's are required. Basic knowledge of software development and medical device development is required to attend the training.

Examination

After participants complete this training, they are eligible to take the exam to qualify as an CPMS® Certified Professional for Medical Software — Foundation Level. The fee for the exam is not included with the cost of registration for this training. 
If the exam is passed, the certificate will be issued by the independent certifier International Software Quality Institute (iSQI).

Course Dates

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GENERAL INFORMATION
Training ID:
Location:Onsite-Training
Date:2/7 -2/10/2024
Duration:31 Days
Time:09:00 AM - 05:00 PM
Language:English (EN)
Examination Fee:$Xx per participant
Online Price:#Xx per participant, plus vat
Services Provided by:UL
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Cancellation Policy

Contractual cancellation right

The registration can be cancelled free of charge 30 days before the training date, after which the following rules apply: 

  • 30 days – 14 days before the start of the training: 50% of the participation fee
  • 14 days or less before the start of the training: 100% of the participation fee
  • This shall not apply when a substitute attendee is named. This is possible until the registration at the beginning of the event.

The relevant cut-off date for the calculation of the cancellation period is the first training day of a bindingly booked training.

The cancellation must be declared in writing and sent by email to the training provider.

Naming substitutes

The participant may, after receiving the registration confirmation, name a substitute in writing prior to the beginning of the seminar.

This change of reservation is free of charge; seminars spanning several days may be transferred only in their entirety, i.e. attended by one substitute.

Date cancellations and date changes

The training provider has the right to change the location of events and/or specify a different date as a substitute. The training provider also reserves the right to cancel dates for organizational reasons (e.g. number of participants too low, illness of the speaker at short notice).

The training provider will notify the participant of the cancellation and of the reason with-out undue delay and will attempt to change the participant's reservation, provided that he agrees to a different date or event location. Otherwise, the full amount of any already paid attendance fee will be refunded in the case of a cancellation; no further claims exist, particularly no refund of travel and/or accommodation cost.

Within UL Solutions we provide a broad portfolio of offerings to many industries. This includes certification, testing, inspection, assessment, verification and consulting services. In order to protect and prevent any conflict of interest, perception of conflict of interest and protection of both our brand and our customers brands, UL Solutions has processes in place to identify and manage any potential conflicts of interest and maintain the impartiality of our conformity assessment services.