Summary lecture: To clear it out from the beginning – “Quality objectives are measurable goals relevant to enhancing customer satisfaction and are consistent with the quality policy. These objectives are initially established when planning your QMS and redefined in management reviews as needed.” – as…
When someone is talking about pre-market approval or notification known as 510(k), they have in mind the US market. In the EU, the concept to get to the EU market is done differently. What you need to know to apply for approval or notification will be explained here…
Lecture Summary: Why is so important to know how to manage and control changes? By effectively handling the changes, you will gain the ability to respond quickly to changes in various circumstances. Those circumstances can be perhaps: What does managing changes essentially mean? It represents…
Let’s try to clear out all the mystery that stands behind this statement. We’ll start with its definition from the previous article where we have defined basic terms in the medical device industry: Medical device manufacturers, as well as other companies involved in the distribution of devices, must…
Lecture summary: The cornerstones of the Quality management system are, in fact, resources, and that’s why you must define, manage, and control all the accompanying resource elements. You have to think of them as critical zones and scopes of the realization process. They should be…
The Medical Device life cycle is considered a development of the product, from the very beginning to the end. What is the beginning, what is involved in the middle, and what is considered the end will be explained in this article. Typically, the medical device life cycle starts with…
An offsite audit is the same as an on-site QMS audit, but the auditor engages with you via technology. The Initial Preparation Prior to starting the offsite audit, most likely you, a medical device company, would need to provide copies of your quality manual, procedures, complaints,…
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…
We can’t emphasize enough how important is to understand the language of medical devices. To meet the requirements and the Regulations it’s essential to understand what is meant by keywords and phrases. Standardized classification and nomenclature of medical devices will serve as a common language…
So, what documentation hierarchy should we adopt? It turns out that this question is a classic for a reason. People have been asking it for many years, and there is more than a little confusion on the answer. The Quality Manual requires many references to…
