Ch 1 Managing Medical Devices within a Regulatory Framework

What is it about?

The medical device product life cycle (PLC) is linked to the regulatory processes in industry leaders in the United States, European Union and other countries who emulate their policies. Still, the link between PLC and regulation is not always clear to many. Product management through its life cycle is critical to end users and the companies that produce and market them.

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Why is it important?

Understanding the inseparable link between regulation, markets, and the medical device industry is critical to the production of safe and effective devices, industry sustainable, clinical improvements, and the long-standing medical ethical position of ‘do no harm’.