Medical Device Product and Project Risk Management

If, like me, you are a program or project manager in the medical device industry, you are responsible not only for ensuring that your new product development projects meet their objectives, but likely also for ensuring all applicable regulatory and quality requirements for developing and commercializing products are met.

For example, for the development of new medical device products, there are Quality Management Systems (QMS) regulations and standards that detail the requirements and guidance for designing, developing, verifying and validating the product prior to its transfer to manufacturing; controls for the production, testing, storage, shipment and service of the product; surveillance of the product and its use in the market; and risk management throughout the product's lifecycle.

It can be a tall order to keep up simultaneously with both QMS and project requirements (enough sometimes to make you want to pull your hair out!), especially now as regulations, standards and guidance are changing for increased vigilance and harmonization. Risk management is a topic gaining increased focus not only for medical devices, but also across all industries.

QMS standards are being updated to incorporate a more risk-based approach, most recently with the September 2015 revision of ISO 90011 and the February 2016 update of ISO 134852 (medical devices). New regulations …

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