Custom Software Development Services
Medical Device Software Requirements
Developing software for a medical device isn’t just about writing code—it starts with getting the requirements right. Gaps, ambiguities, or misalignment in your software requirements can lead to costly delays, compliance issues, and rework down the line. Whether you’re navigating IEC 62304, FDA, or MDR requirements, ensuring interoperability with existing systems, or defining risk controls, this phase is critical to getting your software to market efficiently.
We specialize in helping Medtech companies translate clinical, regulatory, and technical needs into clear, actionable medical device software requirements.
Struggling with defining your medical device software requirements?
Let's talk through your technical needs and assess alignment with our team’s expertise.
In many cases, the requirements phase is the most difficult stage of new product development. Progress is stymied as companies struggle to define the requirements for an innovative new product.
To ensure high adoption of your product, we must first prioritize our understanding of the user by engaging in a discovery phase with our clients and other stakeholders.
By gathering insights from user and market research, we’re able to define your product’s must-have features in order to begin the software development process.
HOW WE CAN HELP
We help Medtech companies translate clinical, regulatory, and technical needs into clear, actionable medical device software requirements
Syncro Medical applies decades of product development experience to help you power through defining your requirements. With an understanding of your needs, we explore various options and analyze the specific requirements relevant to your project, including:
Software Architecture & Design
Clinical & Technical Requirements
Workflow Optimization
Usability Research & Support
Our Approach
— WORKING WITH SYNCRO MEDICAL —
If you haven’t yet completed your software requirements, we can get started with whatever you have available, such as a concept drawing, or high-level product requirements. With your input, our business analysts and software engineers will help you create an FDA-compliant Software Requirements Specification.
Because Syncro Medical specializes in developing software for Medtech innovators, our Quality Management System (QMS) is ISO 13485, ISO 9001, and ISO 27001 certified, and we are compliant with IEC 62304, IEC 62366, and ISO 14971 international standards.
DEVELOPMENT EXPERTISE
We support our clients at every stage of the medical device software design and development process
Learn more about how we help our clients accelerate software R&D for their market-leading devices.