Medical Device Software Development Life Cycle (SDLC) and IEC 62304 Training

Medical Device Software Development Life Cycle (SDLC) and IEC 62304 Training provides an in-depth look at both the SDLC and IEC 62304 (2006).

Our training is for anyone that wants an in-depth look at both the SDLC and IEC 62304 (2006), and it can be completed in-person or virtually.

Why Comply Guru?

Highly Interactive, Engaging Experience
Industry-leading Accelerated Learning Methodology
Delivered by Experts with Proven Expertise

More course information is coming soon.

Course Snapshot

Approved By

Comply Guru

Duration

16hrs

Teaching Format

Virtual or In-Person Learning

Language (s)

English

Price

In-Company Groups

Course Overview

Medical Device SDLC and IEC 62304 Training

What Will I Learn?

A summary of topics within this course include:

Software Regulatory Background
Introduction to the Software Development Life Cycle (SDLC)
IEC 62304: Planning the Software Design
IEC 62304: Risk Management for Software
IEC 62304: Managing Software Configuration and Change Control
IEC 62304: Software Testing

Will I Get A Certificate?

Successful completion will entitle each Learner to receive a digital Certificate of Completion within 1 business day.

How Will I Be Assessed?

In order to successfully complete this course, each Learner will need to:

Fully attend the Live Instructor Workshop as 100% attendance is required

What Are The Technology Requirements?

If you are completing this training virtually, the following applies:

For the live workshops during a virtual delivery, we utilize both Zoom and Microsoft Teams.

Learners need to individually have:

PC or MAC Computer
Reliable Internet
Video Webcam
Headset or Earbuds
Quiet Setting

In relation to the eLearning Modules, in our experience, Workplace IT environments’ internal configurations and available software can vary (new or old), and there may be various limitations or other restrictions in place, and as such, the functionality of any Learning Management System (LMS) may be impacted, restricted and may not perform well. Read the full technology requirements here.

Why Choose Comply Guru

About our Approach to Training

Learn about the benefits and key features of Comply Guru’s Instructor led Learning.

Why Choose Instructor led Learning

Frequently Asked Questions

What is blended learning?

A blended learning course is a hybrid of eLearning modules and classroom modules (in-person or virtual). Each Learner is required to successfully complete interactive eLearning modules in advance of the live workshops that form the second phase of the training.

When do I get access to the eLearning modules?

The standard license is for 90 days (3 months). Access is available 24/7 for the full 90-days even if you complete the course, you can still go back in and view the course content, but you cannot retake the assessments.

Can I transfer to different workshop dates?

Yes, we permit transfers to a future date (s) provided the request is made at least 30 days in advance of the live workshops you registered for. No refund is possible if less than 30 days’ notice is given. On a case-by-case basis, if we can accommodate a transfer at less than 30-days notice, we will but this cannot be guaranteed.

What technology/application is used for this training?

For the live workshops, we use Zoom and Microsoft Teams. Full details will be shared with Learners upon registering for the training. In our experience, Workplace IT environments’ internal configurations and available software can vary (new or old), and there may be various limitations or other restrictions in place, and as such, the functionality of any Learning Management System (LMS) may be impacted, restricted and may not perform well. Read the full technology requirements here.

What if I fail the final CQI & IRCA examination, what happens?

Each Learner is entitled to resit the examination once if unsuccessful in their first attempt. There is a small fee applicable for resit examinations. If unsuccessful after a 2nd attempt, you will need to re-register for the full program.

What if I fail the eLearning assessment, what happens?

Each Learner is provided with 3 attempts at each final assessment. We strongly encourage all Learners to review the course content again before each attempt (if unsuccessful on an attempt). If unsuccessful after a 3rd attempt, you will not be eligible to continue to the live workshops.

What is the maximum number of learners in the live workshops?

We keep our classes to 10 or 12 maximum depending on the blended course, to ensure you can enjoy breakout rooms, activities and Q&As with the Instructor and other participants.

Do we offer in-house / private training?

Yes, we offer in-house training and if you have 5 or more learners that can be trained together, we strongly recommend arranging for in-house training. With this option, there is the possibility of customizing some elements of the training to your organization. Please request a quote and a member of our team will be in touch to discuss this further with you.

Will I receive a course certificate?

Once you have completed the full program, including examination (if applicable), your certificate will be available within 30 business days via your Dashboard once all examination grading has been completed & verified. To access your certificate, you must first submit a short course survey and then the certificate will be available for download/print.

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