Yes, I admit it: after a few trips to Shuzou , I have a Rolexx on my wrist and go for a walk in my NAIKE training shoes. And yet I would never take BAIYER painkillers and would not trust a defibrillator hanging on the wall of my gym manufactured by SIEMEMS. There are things you do not want to take risks with, and health is one of them.
Users demand that the medical and health products on the market are free from defects that may cause us problems. Therefore, there are few sectors where the regulatory requirements are as demanding as those applied in the medical sector. At IKOR we have been developing working practices to meet these requirements for a long time, and through this article we would like to share some of the basic concepts that we have learned.
The concern for health knows no borders. Whether we are in the European Community, the USA, South America or Japan, the health authorities of each country define and apply similar protection mechanisms, although in some countries these are stricter than in others. To do this, they establish a set of rules that must be complied with by anyone wishing to sell medical products in their country.
All these mechanisms share a number of fundamental characteristics. The first of these is Standardisation. When health is at stake, there is no room for uncertainty. Nomenclature, protocols for action, product classification rules … everything is standardised to avoid confusion or interpretations that may cause problems for the user. This level of standardisation is achieved by issuing regulations that establish the ground rules and provide uniform criteria among the countries that adopt them. Knowing these is essential to ensure that they are respected.
But words are not enough, and so another point of agreement is the requirement that each product is provided with a dossier which is known as a Technical file. This document must include all the detailed information regarding its design, risk analysis, verification, validation tests, definition of the manufacturing process, etc. The study and validation of this dossier by a specialised agency will be essential in order to obtain product certification.
One of the points to be included in the Technical file is the result of clinical validation tests to ensure that the product complies effectively with the purpose for which it has been put on the market. And it is not enough that the device is reliable and safe: that electrostimulator which generates electric shocks for muscle rehabilitation must demonstrate through these tests that it helps to overcome the injuries for which the manufacturer has prescribed the device.
Have you found the article interesting? If you are thinking about developing or manufacturing products for the medical sector, follow our blog, where we will soon be discussing other issues related to this activity, such as the classification criteria for different products, what is meant by assessment routes, and the role played by the notified bodies.