The hidden costs of medical device software that teams discover too late
Exclusive knowledge-sharing webinar for Medical Device Manufacturers.
Every medical device company budgets for software development. Very few budget for everything that comes with it.
Over the last years, we've built 10 Software as a Medical Devices and wanted to share our unique experience.
Challenge companies run across are quite similar:
"The software works... but now we need to prove it."
"We underestimated how much documentation and traceability would be needed. Developers complain about doing it."
"Every software update is much bigger than we expected."
If any of that sounds familiar, this webinar is for you.
During this session we'll discuss:
Where medical device companies typically underestimate software costs
Poor or incomplete requirements
Missing traceability
Incorrect software classification
No clinical strategy
Regulatory involvement and documentation that starts too late
No Quality Management System in place
Legacy software and technical debt
We'll also share practical examples of how these decisions affect project timelines, certification effort and long-term maintenance costs. How early technical and regulatory decisions influence the total cost of ownership throughout the product lifecycle.
The meeting will be recorded. Register whether you can join on Wednesday or not. We will share the recording with all attendees.
Agenda
1. Why Software as a Medical Device costs more than expected
Przemek Grzywa CEO, Revolve Healthcare.
Medical device software engineering & compliance agency with over 10 MDR projects completed (20 minutes)
2. Q&A Session (10 minutes)
3. Challenges of achieving QMS compliance for SaMD developers Samantha Shelley ( 20 minutes)
Samantha is an independent Quality & Regulatory consultant with 28 years' experience helping build compliant Quality Management Systems. Specialises in ISO 13485 implementation, audit readiness, FDA and Notified Body inspections, and supporting companies through CE marking and 510(k) submissions.
4. Q&A Session (10 minutes)
5. Closing remarks (5 minutes)
You'll leave with a better understanding of where software projects become expensive, and how to recognize those risks before they affect your own product.
Hosted by
Revolve Healthcare, a Software as a medical device development partner delivering multiple MDR software projects every year, combining software engineering with regulatory expertise.