As manufacturers of microcurrent devices, we are also manufacturers of medical devices. Microcurrent devices used in therapy, rehabilitation and prevention are, by virtue of their intended use, ‘automatically’ classified as medical devices within the meaning of the MDR (Regulation (EU) 2017/745 on medical devices) and the German MPDG (Medical Devices Implementation Act).

If a company manufactures microcurrent devices in Europe, it requires a quality management system in accordance with DIN EN ISO 13485:2016 and a notified body – that is, a body that assesses and verifies the QMS and the technical documentation of the medical device.

A QM system presents most organisations with a seemingly insurmountable task, as it involves regulatory obligations that must be met. Let us take a look at the issue of staff training. The standard states:

“Personnel carrying out activities that affect product quality must be competent to perform these activities through appropriate education, training, skills and experience.

The organisation must document the procedure(s) used to ensure the competence, necessary training and quality awareness of the personnel.” (ISO 13485:2016, page 23)

Essentially, it is a matter of identifying which qualifications are required and which activities are quality-relevant and/or conformity-relevant. (a topic in its own right)

Given that, for example, field staff employed by a distributor are always ‘on the road’ because they are constantly travelling to the next customer, we have opted for a ‘blended learning’ system consisting of online and face-to-face courses.

We rely on the open-source system Moodle. Having gained recognition through various universities, Moodle enables us to set up training courses within our own regulatory framework, not only on-demand but also as live events.

To this end, we host a customised version of Moodle on our own company servers to ensure compliance with cybersecurity standards. We also run hourly incremental backups to meet further regulatory and compliance requirements.

This also allows us to offer staff a degree of flexibility, as a web seminar can be attended from anywhere. New staff members – whether in production, quality assurance or sales via external partners such as distributors – can thus access the latest information on microcurrent devices at any time, regardless of their location.

A (un)popular topic in staff training on microcurrent devices is always the demonstration of knowledge. In our blended-learning system, Moodle, however, this is no longer a problem. The web application offers a wide range of options. From cloze tests and multiple-choice questions to free-text summaries (and much more besides), the only limit for a trainer is their imagination.

DIN EN ISO 13485:2016. Medical devices – Quality management systems – Requirements for regulatory purposes, replacement for DIN EN ISO 13485:2012-11; German version of EN ISO 13485:2016. Berlin: Beuth Verlag.

Also of interest?

Medizinprodukteverordnung 2017/745