Documentation for the Medical Process
From a regulatory agency perspective, the medical industry requires the most rigorous set of requirements, certifications and controls of any design category in the world. Insight has extensive experience with virtually all of them.
Design Controls
Design Control Documentation is a requirement in producing most medical devices. Insight has adopted a formal design controls process that is modeled after those in the ISO 13485 standard, and can support our client's internal design control procedures or manage an entire design history file (DHF). These procedures include documented design inputs, design outputs, risk management and verification procedures. As needed, Insight manages projects to meet quality and regulatory standards, while maintaining creativity throughout the development process.
Requirements Tracing to the Source
In concert with a proven design control system, Insight can provide requirements tracing functions within each program. With multiple applications including web systems, all critical development decisions are traced back to their core user and market requirement.
The Human Factors Requirements Made Easy
Insight provides extensive task flow maps and research analysis, recommendations reports and detailed interaction design specification, which completely satisfy all GMP requirements for effective human factors inputs and applications.
Certifications Support - Documenting the Plan
At the beginning of each program, the Insight and client team establishes the requirements necessary to receive desired certifications. Insight keeps detailed reports for test plans and results that provide complete information for inclusion in applications for certifications including UL, CE, TUV and 510K submissions.