Enabling you to identify and mitigate the intrinsic risk in your operations, supply chains and business processes.
Evaluating how your products and services meet and exceed quality, safety, sustainability and performance standards.
Validating the specifications, value and safety of your raw materials, products and assets.
Interactive Risk Management Solutions for Medical Devices
Risk Management is a major requirement of the third edition of IEC 60601-1. Our consultants work hand-in-hand with you and your team to develop strategic solutions that will address your specific needs. We provide support throughout your entire product development cycle to help you navigate the complexities of building a Risk Management File to incorporate risk analysis, hazard analysis, production/post-production device monitoring, and more.
At Intertek, we know medical devices, we know risk management, and we know how to help you identify the simplest, most effective approach to constructing your Risk Management File. Ask us about our “3-Step Kick-Off" for ISO 14971 Risk Management Consulting:
Intertek does not provide consulting services for management systems certification. Any consulting activities provided by Intertek are separate and independent from certification activities.
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