Within any industry, combatting operational risk while balancing financial responsibilities are chief concerns. For medical device manufacturers, there is additional regulatory pressure to prove that assets are properly maintained and calibrated. In this post, we’ll identify three common asset management pitfalls experienced by medical device manufacturers and talk about how to build a strong …
The US Food and Drug Administration (FDA) consistently lists inadequate maintenance and calibration procedures as a top reason for issuing Form 483 observations to medical device manufacturers (hint: this is NOT a good thing). Within highly regulated industries, calibration program problems can leave you open to risks ranging from delays in time to market to increased liability and patient …
A recent meeting with a large medical device customer lead to an enlightening discussion on the differences between International Organization for Standardization (ISO) and US Food and Drug Administration (FDA) standards and regulations as they apply to medical device manufacturers. This is a short overview of a few of the key differences between ISO and FDA compliance and a quick guide to …
