Quality Management System

Posts tagged with “Quality Management System”

Vesna Janic

When do you need a Quality Management System (QMS)?

“When do I need a Quality Management System (QMS)?” is the most common question that we get asked by new clients who are just entering into the medical device field. The answer depends on your target market and your exit strategy. To be frank, it is somewhat a chicken and egg thing.

Martine Janicki

How a Project Management Office (PMO) Helps Effective Medical Device Development

The term “PMO” (Project Management Office) appears ever more frequently in engineering firms, but is still not well understood. So what is a PMO, how do they impact medical device development, and what does the PMO look like at StarFish? In other words, why bother? For organizations that do not use a PMO, there are […]

Vesna Janic

FDA Recognition Standard List Number 30 for Medical Devices

On January 15, 2013 the Food and Drug Administration (FDA) published an updated list of standards the Agency recognizes for use in premarket reviews of medical devices. This publication, entitled “Modifications to the List of Recognized Standards, Recognition List Number: 030” will assist manufacturers who choose to declare conformity with consensus standards.

Vesna Janic

Date Format Quandary for FDA UDI for Medical Devices

In my last blog I wrote that the FDA proposed a rule that requires a unique device identifier (UDI)  to be placed on the label and packaging of a marketed and sold medical device. It turned out that internally at StarFish, the required date format caught the attention of our engineers more than any other […]

Vesna Janic

FDA Unique Device Identifier Rule

Companies that are selling medical devices in the US have to consider a new rule that was published by the FDA on July 2nd, 2012. The proposed rule requires a unique device identifier (UDI) in both plain text and machine readable format (i.e. bar code) placed on the label and packaging of marketed and sold […]

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