Design Controls
During our long history of helping medical device companies improve their product development processes, we have learned that success is driven by a strong commitment to process improvement, a solid understanding of process and information flow requirements, and a focused implementation team dedicated to prompt delivery of the targeted improvements.
Product Development Lifecycle
It is critical to anticipate and address the many regulatory requirements essential to a successful product introduction. Regardless of where you are in the process, Engisystems' experts can help ease your Regulatory and Quality Assurance burden, allowing you to focus internal time and resources on achieving business-critical goals.
Policies & Procedures
We can help develop a complete process vision, map FDA process and regulatory requirements, and leverage structured methodologies to bring better products to market faster. All while consuming less of your organization's valuable resources.
Design Reviews
Design reviews are a key design control element in quality system regulation 21CFR820.30(e). These reviews are intended to ensure that designs meet the appropriate requirements definition, and also act as a mechanism for the identification of potential weakness associated with safety, reliability, efficacy, manufacturability, service, implementation and customer misuse of the device. As experts in FDA Regulation, Software Development and Medical Devices, Engisystems provides insightful, cost-effective design review assistance.
Design Verification & Validation
Validation is an integral part of continuous improvement. That is why Engisystems assigns only Senior Software Validation Engineers (not technical writers) who understand your equipment and processes to verification & validation service engagements.
Software Development Lifecycle
As experts in medical device software, we are well versed on a broad range of development lifecycles and frameworks. Our solutions are customized to your existing model. One of the more common lifecycle models is the waterfall approach illustrated below. Engisystems is versed in supporting processes as well as the full development lifecycle.
Each model offers innate strengths and weaknesses. When discussing structured processes and process improvements, we tailor our recommendations to work with and maximize your current solutions.
Medical Device Software Validation
Software validation comprises an integral part of the device design validation process. Engisystems works with medical device manufacturers to cost effectively validate software that is part of, or classified as a medical device. In practice, software validation activities may occur both during, and at the end of software development lifecycles. Our extensive knowledge of best practices and applicable medical device regulations help streamline the validation process.