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Evaluating The Authority Of The Medical Devices Directive On Pharmaceutical Training

2nd March, 2011 - Posted by health news - No Comments

The medical devices directive was published by the European Commission in 1993 with the aim of setting out laws regulating the manufacture of medical devices in its member states. These laws ensure that medical devices that can be legally sold on the European market are safe and fit for purpose. So how exactly has the Medical Devices Directive effected the area of pharmaceutical training.?

Medical devices manufacture

It is imperative for manufacturers of medical devices to have an understanding of how they are used in real life to make sure that they are fit for purpose and comply with the Medical Devices Directive. In addition they must also be aware of the laws and standards that should be met when producing and testing medical devices. The best way for manufactures to ensure that they meet these aims is to secure pharmaceutical training for their staff.

Types of training

Such pharmaceutical training can be received from specialist providers and can be provided in several forms; however there are two that are most common. Firstly, there is the form of in-house training whereby a pharmaceutical consultant will visit the place of production. By having this face to face contact the consultant is able to show the correct techniques to management and staff that should be used to ensure compliance with the Medical Devices Directive.
In the second instance, offsite training can be provided by the consultants. Information and new techniques that are learnt can then be shared with colleagues when they return back to normal duties.

Counting the cost

It is usually cheaper to opt for offsite training as opposed to paying for consultants to train your staff onsite. However, this means that you are relying on those that attend to relay what they learn to other staff members in an accurate manner. If the level of training is in an especially complex area it makes best sense to have the training done onsite so that all members off staff receive their information fisthand, increasing the likelihood of achieving compliance with the Medical Devices Directive regulations.