EU to FDA Approval
Many companies face issues when trying to bring their existing medical device to the US market. According to a Stat News article, getting FDA Approval is often a longer and more expensive process than getting approved by the EU. This makes it extremely important to make sure your device meets all FDA regulations before you submit.
The RND Group recently partnered with a leading medical device company who filled a portfolio gap by purchasing a niche software company in Europe. Their acquisition of this company included a large laboratory management software package.
The RND Group performed a GAP Analysis on their software development documentation to identify where their software was at, where it needed to be, and determine compliance with FDA regulations.
Using the results of the analysis as guidance, over 80 user needs and 1000 product requirements were added to the Design History File.
A risk assessment was also performed as part of the analysis and used to further define the remediation work. A large portion of the remediation was presented through a verification package with the following features:
- Verification testing plan
- Verification test cases
- Execution of the verification artifacts
The Risk Assessment was leveraged to assure the testing methods were effective as well as efficient.
The RND Group leveraged the client’s quality management system allowing for a seamless handover at the end of the project. All user needs, requirements and verification test cases were written and managed in JAMA allowing for efficient collaboration with a distributed team (Chicago, Indianapolis, Dallas and Milan Italy).
The project demonstrated that an existing product can be brought into line with the FDA documentation requirements. The RND Group’s extensive knowledge of medical device standards allowed us to assess the gaps, develop a plan to address the deficiencies and execute the plan to bring the product into compliance.
With over 20 years of experience in regulated software engineering, we’ve built a heritage and reputation for building specialized software with precision and care. The RND Group can point with pride to products that have been successfully introduced into the medical device marketplace.
Your project deserves a specialist.
Contact us to see how we can assist with your project here.
FDA Part 820, Part 11
Requirements development and management
ISO 13485, HIPAA, IEC 62304
Software risk analysis and management
Software life cycle processes
Microsoft Windows 2012 Server – Target OS
JAMA – Requirement, Test Case & Test Execution
Oracle 11.2 – Target Database
LIS2-A2 / ASTM 1394 – Laboratory Communications
Oracle Virtual Box – Test Environments