“WHEN I’M USING A VASCULAR INTERVENTION DEVICE CONTAINING SOFTWARE BUILT BY SYNCRO, I’M 100% CONFIDENT IN THE QUALITY OF THE DEVICE AND WHAT THAT QUALITY MEANS FOR MY PATIENT”
– George Heyrich, MD, FACC
Top Medical Software Quality
In the world of medical device software development, quality stands above all. At Syncro Medical we have spent decades refining our process and practices to ensure that your medical device software meets the commitment that you make to your marketplace.
What does it mean for your customers and their providers and patients when your product has “Syncro Inside™”? It means that your medical device software was developed with an uncompromising commitment to quality, health, and safety – a commitment that extends to your customers and to their patients. How do we know? Because Syncro Inside™ reflects 30+ years of successful partnerships and the highest levels of client satisfaction.
Medical device development is changing, and medical device software is no exception. Today, software development outsourcing makes sense, and choosing the right software development outsourcing partner is a critical business decision – one that can have far-reaching consequences.
Stand ahead of your competitor. Trust Syncro Inside™ to assure the quality that sets you apart.
Quality Throughout the Development Cycle
A WELL DEFINED DEVELOPMENT PROCESS
Syncro Medical closely adheres to the development process defined in the Quality System that applies for your project. No exceptions. Our engineers understand the critical importance of documenting design, coding to a standard, and thorough unit testing, as well as design-and-code-reviews. Syncro Medical’s separate QA engineers are an integral part of the development team assigned to your project. If independent verification of your software is required, count on us. Our QA team will create the verification test plan as early as possible in the development cycle so that testing against the plan can start right away. As a result, defects at verification are minimized or eliminated. In addition, Syncro Medical can provide software Risk and Hazard Analysis and Requirements Traceability appropriate to your product’s Level of Concern.
We’ll involve our Quality Director to work with you from requirements through to test, ensuring that functionality is clearly specified, that the code meets specifications, and that the entire project is documented properly for regulatory submission.
Our Quality Systems
Syncro Medical uses a comprehensive Quality System specifically focused on the software component of medical products. If you prefer, we’ll use your Quality System. The choice is yours. Many clients prefer a hybrid approach, including elements of both Quality Systems. We’re very flexible, and will adapt as needed to suit your specific needs.
ARCHITECTURE BEST PRACTICES
At the early stages of the project, Syncro Medical takes a deep dive into the architecture of your new product to maximize maintainability, scalability, flexibility, reusability, and testability. For example, we may suggest an N-Tier architecture to decouple and abstract out functionality so if something changes, we minimize the breadth and depth of the change, and thereby the cost impact. We also incorporate design patterns (such as MVVM) to further separate the presentation from the domain logic. This model allows us to unit test more of the presentation layer, reducing development complexity and improving quality. A thorough architectural design at the beginning ensures that we can be totally flexible and thereby handle change requests quickly and cost effectively.