Our Blog

In this section of our website, we are sharing news, updates, relevant opinion articles and insights by our experts & other contributors. We will also share achievements and other related content from all of us at Kelmac Group®


Anna Miedzinska

Medical Devices Consultant

The Goal of effective Quality Systems based on ISO 13485

January 09, 2014

The Medical Device QMS standard ISO 13485 takes this very approach and shows us how the organization’s activities all interrelate and how they can be made to work in sync. In the Medical Devices world a key principle is the Risk connected with the use of the product. Risk evaluation should be the basis for most decisions in a medical device organization. It is also used by regulatory and statutory agencies to determine the extent of activities necessary at each medical devices organization and the oversight necessary from agency’s side. We need to keep in mind also the Eight Principles of Quality Management, which form the basis for the series of ISO quality management standards. These are: Customer Focus Lead…

Eoin Philip Kelly

President

Kelmac Group® delivers training in Colombia

September 09, 2011

The partnership has been enormously successful and attached is a picture from a training course delivered in September 2011 in association with ICONTEC in Colombia – IRCA Certified. We will post more pictures from around the globe of Kelmac Group® training events in association with our partners, including Quara Group.

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