Regulatory Affairs (RA) professionals play an important role in the medtech industry yet they are not so often heard of. The role of the...

There are times when life teaches us what is truly valuable. Like coming out intact on the other side of a pandemic where phrases such as...

Imagine the predicament of a hairstylist in Africa who found the only tools available were those developed for styling hair in Europe. Or...

A bit of History We’ve all heard of food as medicine, thanks to the famous quote attributed to Hippocrates, the founder of Western...

If necessity is the mother of invention, then crisis is perhaps its father, for some of the greatest human innovations have been sired in...

In recent years, the medical device quality, regulatory, and clinical environment has evolved tremendously. Continuous training has...

After entering into force on 26 May, the EU MDR still presents areas of ambiguity. Such is the case for requirements concerning the...

Device classification is one of the initial activities in the lifecycle of your product. This step informs the extent to which a specific...

For the past four years, the medtech world has been on its toes, sometimes nervously, in anticipation of the European Medical Device...

Getting medical devices on the South African market has become a hot topic lately. This article is the first of a series of articles on...

The evaluation of technical documentation (TD) by a notified body is the central element of the conformity assessment procedure towards...

We have all come to love the idea of innovation. Whether we're hearing about it in the healthcare industry or fintech, innovation has...

The Food and Drug Association, more commonly known as the FDA, is the oldest consumer protection agency and is part of the U.S Department...

The Medical Device Regulation (Regulation EU 2017/745), or MDR if you like abbreviations, is still planned to come into application on 26...

I love the start of a new year for two reasons. Firstly, it always feels like a clean slate, in some way or another (given the obstacles...

As the year comes to an end, I thought it would be fitting to give a breakdown of the European Medical Device Regulation (MDR) and what...

We've certainly come a long way. This statement means something different to all of us, but we can all agree that almost every area in...

We can all recognize that COVID-19 has given us a clear reminder of the increasing cost of healthcare, both locally and globally. With...

Product and service development are at the heart of customer satisfaction. In an ideal world it all begins with someone (say, person A)...

We are living in a world where uncertainty has become the new normal, where Zoom calls have taken the place of the board room, and where...