Risk Management
Today Medical Device businesses inevitably face ongoing risks to finances, products, data, equipment, property, and personnel.
CHALLANGE
With each passing year, the knowledge needed to handle risk management is expanding, and successfully having avoided business and compliance risks in the past doesn’t necessarily mean that an organization can consider itself safe from current or future threats. As if that weren’t enough, Medical Device businesses are also expected to be compliant with ISO14971, and ISO13485, the latest risk management standards.
SOLUTION
QRT provides proven strategies that allow organizations to manage risks in a practical, effective, and proactive manner. Our overarching goal is to help you become risk-adept and agile.
QRT uses a comprehensive and collaborative approach that enables risk management strategies to be implemented as an inherent, vital part of product life cycles, supply-chain operations, and quality management systems all designed to deliver patient safety. Recognizing, planning and implementing risk management strategies across the product lifecycle will ensure that risk controls are in place throughout a process to verify that specific activities operate according to plan and are proven to be effective.
Our team will develop risk plans and devise a customized strategy through evaluation of your current process and procedures to identify areas of risk, determine an effective strategy, implement the plan and continuous monitoring. Risk management, compliance, and quality monitoring are deeply interconnected within the Medical Device industry.
BENEFIT
Partnering with QRT will support your risk management requirements
- meet their risk management regulatory requirements,
- monitor ongoing potential risks, and make data-driven decisions to improve risk avoidance and mitigation
- while achieving business strategies and preparing for future growth.