Risk Assessment and Management

Proven Process follows a Risk Management Process modeled after ISO 14971The medical devices we design and develop for our customers at Proven Process will play a role in helping physicians and other medical staff safely deliver treatment, care, and therapies. In addition, our activities and the products we provide are subject to strict regulatory controls. Compliance with these regulations is primarily designed to ensure patient safety. However, compliance also helps mitigate financial risk for our customers by avoiding setbacks that could impact the on-time delivery of products.


Risk Management at Proven Process is continuous and shared across our entire organization.


With this in mind, we are committed to providing our customers with medical device innovations that are safe and reliable, and upholding the integrity of our contractual agreements. To fulfill this promise, Proven Process follows a Risk Management process that is modeled after ISO 14971 and involves a systematic approach to identifying, assessing, and managing risks that could compromise the safety and effectiveness of the products we develop. Risk Management at Proven Process is continuous and shared across our entire organization. From executive leadership to engineering and administrative staff, each employee is held accountable for risk mitigation in a way that is relative to their level of responsibility in our design and development operations.