Fission University is reinventing the way that training is provided in the Medical Device Industry. We are going beyond basic content delivery and the rote training provided today to provide a set of courses and coaching activities that can help you to build domain expertise in this industry.
Our courses are accessible and our one-on-one coaching allows for you to build the expertise needed to excel and become a leader in the industry.
Try one of our introductory courses today to see for yourself the Fission University difference.
"Include a testimonial sharing why your students love your content."
- Jane Doe
At Fission University
We believe that a well designed Quality Management System can create value for an organization, that Quality is an Investment into the business, and auditing can be a useful and value added activity and can contribute to a robust quality culture within an organization.
We see compliance requirements as good business practices that when properly implemented can result in improved customer experiences and improve the bottom line.
Highly experienced in Quality Management Systems and Regulatory Compliance: We have developed or performed significant QMS remediation work for a broad range of Medical Product Companies, developed robust regulatory strategies, and led many successful regulator interactions including US FDA, EU Notified Bodies, ANVISA, Health Canada, and more.
Extensive Auditing Experience: Nearly a decade of lead auditor experience and have performed full Quality Management System audits covering ISO 9001, ISO 13485, 21 CFR 820, Part 11, EU MDR, and MDSAP.
Design Control and Submission Experience: We are leaders of product development teams, including both Medical Devices and Combination Products having accomplished many successful FDA, Health Canada, and EU Submissions.
We are leaders in Software as a Medical Device
Our industry leading software as a medical device course package includes everything you need to get started in the fasted growing segment of the Health Technology Industry.
