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Showing posts tagged with: audit requirements

Extraordinary circumstances require extraordinary measures-Offsite auditing

Extraordinary circumstances require extraordinary measures-Offsite auditing

Certain audits of medical devices and processes are essential for MedDev companies if they want to place their product on the European market. However, audits are not used only for those reasons. There are used for a variety of reasons, including assessing compliance with standards and regulations, adherence to requirements and specifications, evaluating process and system...
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8 things to know about CE approval process for Medical Devices

8 things to know about CE approval process for Medical Devices

As a medical device manufacturer which wants to place its product on the European market, you must be aware of all requirements to do so. Of course, one of the first things, you need to comply with Europe’s Medical Device Regulation (MDR). There are few ways to do so, and it’s known as conformity assessment routes. We...
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Cup of Joe 42# - Dealing with CAPA

Cup of Joe 42# - Dealing with CAPA

CAPA is a system that consists of improvements taken to eliminate the causes of non-conformities or any other undesirable situation within an organization’s process. CAPA importance Every company should develop a strategy for CAPA as part of its overall quality system. To manage the suitable CAPA activity, it is important to track, manage and evaluate all different quality...
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