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Medical Device Software Regulations and Standards Training

Available as a virtual instructor-led seminar.

This course provides a foundation for understanding the regulatory landscape for software development within the medical device industry. Regulations are not much different from one country to another, which means understanding the EU and Medical Device Single Audit Program (MDSAP) countries provides a starting point for most countries where organizations would be marketing.

In this class, you will learn the regulatory requirements from the EU, US, and MDSAP countries, including requirements for submissions and software-related guidelines, in addition to the standards associated with software (ISO 13485, ISO 14971, and IEC 62304). The course also provides an overview of cloud computing in a regulated environment, artificial intelligence, and machine learning within the regulations.

 

Upcoming Dates and Locations

Virtual seminars run as 1/2-day sessions. In-person classes run as full-day sessions. See the virtual session daily class times.

Location Start Date Days Cost Public Course Private
VIRTUAL DELIVERY (Eastern Time) 07/12/2022 4 $2995.00 Add to Cart CONTACT US
VIRTUAL DELIVERY (Eastern Time) 11/15/2022 4 $2995.00 Add to Cart CONTACT US

What You Will Learn

At the conclusion of this workshop, you will be able to:

  • Identify the deliverables for a software product submission, based on device class
  • Determine the evidence that would be needed to support software regulatory requirements in the EU and MDSAP countries, and IEC 62304 requirements
  • Identify the deliverables for a software product submission, based on device class
  • Describe the regulatory framework for software
  • Describe the IEC 62304 standard requirements for software development
  • Explain the relationship between the software regulatory requirements and the applicable standards
  • Provide an overview of the resources containing the key regulations, standards, and guidance documents
 
 
 
 

 

Who Should Attend

This class is recommended for software developers and those involved in non-regulatory functions associated with software. That includes:

  • Software QA Engineers
  • Program Managers (managing software)
  • Software Test Engineers
  • Scrum Master (lead of Agile development)
  • Solution Architects

 

Virtual Half-Days: 4
In-Person Full-Days: 2
CEUs: 1.6

Virtual Session Details

Oriel STAT A MATRIX virtual instructor-led training (VILT) is a real-time internet-based learning experience where the instructor and learners are in separate locations. Oriel STAT A MATRIX’s VILT technology platform is designed to simulate a traditional in-person classroom experience and allows for 2-way dialogue, breakout sessions for engaged workshops and hands-on exercises, and group work using virtual breakout rooms. This provides for an engaging learning experience in which participants can connect with the content and interact with both the instructor and other classmates.

The learning objectives and topics covered during VILT are the same as those for the in-person version of the course. To accommodate the VILT format, classes are delivered at a pace well suited to virtual instruction, and the structure of class workshops and exercises has been modified to work best in the virtual environment.

Online Training Schedule

This class is delivered across 4 consecutive days. Sessions run daily from 1:00-5:00 p.m. (Eastern Time).

Technical / Logistical Requirements

To participate in this learning, first and foremost, we need your engagement!  You will also need:

 

VIRTUAL CLASS TIMES Close

Public virtual seminars run daily from 1:00-5:00 p.m. ET. Seminars run on Eastern Time unless otherwise noted in the Location field.

Auditor classes that require a final exam start at 11:30 a.m. on the last day to administer the final exam.

For more information download the virtual course agenda (close this window and navigate to the top of the course page) or Contact Us.

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