Medical Device Software Consulting
Guiding your software journey from development to FDA compliance.
Software Consulting
Bold Type provides expert software consulting tailored to the unique challenges of medical device startups and OEMs.
Whether you’re building in-house or working with a development team, our consultants offer guidance on everything from regulatory strategy to cybersecurity requirements.
Our Approach
With expertise across app and embedded software development, we help you define the best practices and frameworks necessary for FDA approval and market success.
We can provide Standard Operating Procedures (SOPs) specifically written for software development teams that help meet requirements for ISO13485 (QMS), IEC62304 (Medical Software), ISO14971 (Risk Management), ISO62366 (Human Factors), and more.
Common Scenarios We Support
Clients with software teams lacking medical device experience.
Companies that need an independent review of software and documentation.
Early-stage startups transitioning software from the prototype phase to formal product development.
Benefits
