Regulations Posts

Be Aware! Security Training and Employee Engagement

Be Aware! Security Training and Employee Engagement

Tom Colgan, Director of Cyber Security, Pilgrim Quality Solutions

As agents of quality and compliance within the Life Sciences industry, we are all well aware of the importance of security awareness training in order to be compliant with various frameworks, laws, and regulations, including HIPAA. But in practice, does your organization’s awareness program simply “check the box,” or do you believe your efforts are having an impact?
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The Path to ISO 13485:2016 Compliance – What’s Your Next Step?

The Path to ISO 13485:2016 Compliance – What’s Your Next Step?

Justin L. Smith, Manager of Product Management, Pilgrim Quality Solutions

This industry continues to buzz about ISO 13485:2016. The February 28, 2019 deadline is now less than two years away, and many organizations need to take advantage of every minute between now and then to be compliance-ready. Plus, busy registrar schedules, combined with your company’s certificate expiration, mean that you may have less time to prepare than you think.

Pilgrim is here to help you along the path to compliance. Are you ready to move forward?
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New Guidance on Postmarket Surveillance from the FDA

Mark Crawford

The FDA continues to roll out new guidance documents for medical device regulations—this time presenting updated rules for postmarket surveillance.
The draft entitled “Postmarket Surveillance under Section 522 of the Federal Food, Drug and Cosmetic Act,” released by the FDA on August 16, provides a summary of the revised postmarket surveillance program, including new modifications. (more…)