Save Time and Avoid Costly Mistakes
Associated with Regulated Software Development Projects

As published in the December 2007 issue of BIOTECHNOLOGY HEALTHCARE, our article titled "Lower Cost and Faster Product Approval Through Proper Software Design Controls" provides useful information about common software engineering issues medical device manufacturers and emerging companies must deal with as they seek to achieve regulatory approvals and launch new products into the marketplace. In addition, it summarizes the software verification and validation (V&V) solutions we offer to help you navigate the sheer volume of regulations, guidance documents and standards associated with 510(k) submissions and medical device software engineering.

We offer start-ups and growing life science companies the following services to take control of their software development process and speed the time-to-market:

Project Management
Ensure your developers create great code and projects remain focused on end user requirements. Our PMP certified associates have the expertise and skill sets to speak intelligently to engineers and assist internal project managers with timelines, budgeting, requirements, delegation and risk mitigation.

Requirements Engineering
Fixing problems discovered during the requirements phase is much easier than fixing them after your code is written. Coding, testing and documentation become clearer when everyone understands the software's purpose. As a result, we make sure requirements are designed around three main principles:

• Requirements are written in the language of the user not the developer.
• Requirements are testable with simple and intuitive interfaces.
• Requirements are complete so any development team can implement then (even if they aren't familiar with your specific project).

Software Estimation
Based on project phase, we use multiple estimation techniques to give stakeholders confidence that goals will be met. This process of aligning resources, budgets and timelines is driven by two central themes:

• Software estimates should not be considered a single point in time but rather a range of time that all parties buy into.
• Developing honesty and trust between those generating the estimate and those performing the work.

Process Development
In addition to producing a great piece of software, we make sure all stakeholders are involved in mapping clear processes that produce the documentation required for 510(k) submissions and other regulatory approvals. When done properly, the benefits of process development far outweigh the time and energy used to create them.

Please contact us to learn more about our software engineering capabilities and how we can work together to accomplish your goals.