Webinar: How To Prepare For FDA Migration To ISO 13485 And MDSAP

[fa icon="calendar'] Mon, May 06, 2019 / by David Bolton

 

Media theorist Marshall McLuhan may not have had quality management for medical devices in mind when he coined the phrase “global village” in the 1960’s, but the fundamental interconnectedness of modern society has brought his concept to life. And while technology is at its core, the need for international harmony in the regulatory sphere is arguably a key QMS issue.

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Medical Devices ISO Standards Life Sciences Regulatory Compliance iso 13485

Should Life Science Companies Comply with ISO 9001 or ISO 13485…or Both?

[fa icon="calendar'] Tue, Sep 05, 2017 / by Alexa Sussman

Many Life Science organizations are asking that question as new ISO deadlines approach.

Medical device manufacturing companies need regulatory compliance software to maintain compliance and be sure that products are safe and effective. But there are multiple options that complicate the process of deciding which standard to comply with. Some make the decision to comply with more than one for the sake of covering all bases.

Here’s a breakdown of what Life Science organizations should consider about the two most common standards for medical device companies: ISO 9001:2015 and ISO 13485: 2016.

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ISO 9000 Life Sciences iso 13485

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