ISO 13485

In the modern world, technology is pervasive. It impacts all areas of life from basic human interaction to how we shape and work with the world around us. From its inception in the 1980s, the internet has been a growing part of technology, encouraging increasing connectivity and the growth of the IoT (Internet of Things). The invention of the computer replaced many older-fashioned technologies (or was incorporated into them). For example, various versions of the cash register have been around for centuries. Modern versions include computers that talk to each other and the company’s network – some even helping to track inventory.

What is quality, and why does it matter? Quality is defined as the “measure of excellence or a state of being free from defects, deficiencies and significant variations,” (WebFinance Inc.). In today’s competitive industries, manufacturers need to keep a multifaceted approach with their products to be profitable – not only do the products need to be manufactured quickly, but they need to be high quality. Especially in the medical industry, it is no longer acceptable just to produce the cheapest, fastest product possible. Manufacturers are expected to reduce costs across the board while maintaining high quality standards – consumers want it all. This can leave upper management in a difficult position where they are pressured by stakeholders to choose between these two goals. It’s a delicate balance that must be maintained.

One audit for five markets – Australia, Brazil, Canada, Japan and USA General In the past, medical device manufacturers who wished to license their products in Australia, Brazil, Canada, Japan and USA had to demonstrate fulfilment of the national regulatory requirements of each country within different approval processes. This naturally involved a great deal of time and expense. Now, IMDRF (International Medical Devices Regulators Forum) has developed a new unified program – the MDSAP (Medical Device Single Audit Program) – which covers different regulatory requirements.