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.
Each organization has its own way of working together. However, when it comes to manufacturers specializing in the medical device industry, it is vitally important to have the quality team work closely with the engineering team. But why and what are the benefits?
The quality teams specifically work with the ISO 14971 standard while the Engineering teams work on the requirements in Third Edition 60601-1. It would seem natural that each team should be left to work on one’s own areas of expertise. However, it is more beneficial if both teams can work together from the start to ensure a seamless and more efficient form of certification since the Third Edition of 60601-1 has incorporated requirements for risk management that need to be addressed.
"In order to achieve a competitive advantage and gain success in today’s competitive environment for medical devices, organizations must evolve and change," said Todd Konieczny, North American North American Medical Technical Leader. "Manufacturing companies must have their quality and engineering teams work in tandem from the start, enabling them to achieve a timely certification process and (ultimately) take their product to market, faster."