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...
by LindaMarie Beitler | Aug 11, 2021 | Uncategorized
Frequently Asked Questions for Complaint Handling Patient safety is paramount within the medical device industry. Managing customer complaints is an inevitable, and essential part of quality improvement. Your product is not perfect! And it is a regulatory requirement....
by LindaMarie Beitler | Aug 2, 2021 | Uncategorized
Better Methods for Setting Meaningful Metrics Metrics have, in recent years, been examined and reexamined for their influence on everything from our management engagement to employee performance. Metrics have ridden the high of being a sure focus of how we show our...
