by LindaMarie Beitler | Aug 3, 2022 | Uncategorized
FREE WEBINAR The Harmonization of Regulatory Guidance: QMSR and ISO 13485 The FDA finally released their much talked about proposed rule change for the Quality System Regulation to the Quality Management System Regulation in February of 2022. The rule aligns the FDA...
by LindaMarie Beitler | May 25, 2022 | Adult Learning, Uncategorized
Trending in Root Cause Analysis for Breakthrough Improvement All quality events are important. But they are not equally weighed. It is crucial to perform a risk analysis on events. This will allows resources to focus on the higher risk events, and forces us to trend...
by LindaMarie Beitler | May 4, 2022 | Uncategorized
The Perception of Quality Where quality is concerned, simply designing a device to accommodate variable quality is not enough. You must look beyond functionality, beyond how durable it is or how well the pieces fit together. You also need to consider attribute...
by LindaMarie Beitler | Mar 23, 2022 | Uncategorized
PROCEDURES AND DOCUMENTATION: GETTING IT RIGHT The Life Science industry is an ever-evolving industry which has seen amazing growth and innovation over the past two decades. One thing that has not changed within our industry is the need for quality procedures and...
by LindaMarie Beitler | Nov 1, 2021 | Uncategorized
Technical Writing Wrongs – Observations from the Field Several years ago, a quality manager explained to me that nothing is worthless. He said, “Herb, even your biggest mistakes can serve as good, bad examples”. This white-paper will point out some of those common...
by LindaMarie Beitler | Sep 20, 2021 | Uncategorized
Medical Devices Regulatory Convergence Through ISO 13485 Thirty or more years ago, each regulator used to set its own QMS rules. But, in the early 1990´s manufacturers and regulators realized that standardizing those rules would benefit stakeholders including...
