CERTIFIED: ISO 9001 | ISO 13485 | ISO 27001
CERTIFIED: ISO 9001 | ISO 13485 | ISO 27001
MEDTECH PRODUCT DEVELOPMENT SERVICES

REQUIREMENTS ANALYSIS

A Solid Framework is Essential for Successful Software Product Development

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.

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:

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 and ISO 14971 international standards.