Assistance with 510(k) Submission Process

Syncro Medical brings years of regulatory experience to provide a full software documentation package for your Design History File

Virtually all of the products we develop for our clients are submitted by them for regulatory approval, whether it be FDA 510(k), PMA, or EU. Syncro Medical will work with you to provide a full software documentation package for your Design History File.

Having developed the software for hundreds of medical products, Syncro Medical thoroughly understands the nuances of the 510(k) submission process and compliance with ISO 13485 and other standards.  We’ll apply our wealth of experience to the content creation for FDA-required software development documents, such as the SW Architecture Document, SW Design Specifications, and the SW Verification Plan and Test Results. For certain docs such as SW Requirements Specifications and Risk Analysis that require a joint effort, we’ll work side-by-side with you on the analysis and content.

If you wish, we can be available to review certain regulatory documents not created by Syncro Medical.  For example, many of our clients ask us to review system-level documents such as product requirements or hardware/software interfaces, whereby we can check for completeness and correctness from the software perspective.

For early-stage companies, Syncro Medical can be a critical resource when navigating the complex medical device approval process.  If you don’t yet have a quality process in place for the software component of development, Syncro Medical will make its own QMS available to you. Using our QMS, you can jump-start the regulatory documentation process by using our docs and templates.

Documentation is a critical component of the medical device development process. Rely on Syncro Medical’s decades of experience to help you create submission-ready documents for your design history file.

Explore Our Other Software Development Services

Requirements Analysis

Architecture & Design

Prototyping

Software Implementation

Testing & QA

Project Management