Exatronic certifies its system for design and manufacture of medical devices

Exatronic has successfully concluded the certification process according to the standard ISO 13485:2003 – Medical Devices – Quality Management Systems.

This process already allowed us to already certify our first medical device under MDD 93/42/CEE and to be granted a CE0120 mark, meaning it can be distributed and used in the EU market.

Exatronic’s new medical device is built around the concept of a transcutaneous drug delivery system. Electrical pulses are applied through the human cutaneous surface in order to amplify the entrance movement of ionic charged drugs into the human body. This method presents several benefits concerning to the administration of drugs when benchmarking with traditional methods, such as topical, oral and invasive. For the patience, it is painless and non-invasive, so there is no risk of trauma or infection. Another known advantage is that the process by itself is perfectly manageable so it can accurately control the dosage and direction of the drug administration.

Both certifications were done by SGS-UK, an international official notified body.

Exatronic reaches this achievement after 2 years of R&D and great cooperation with Portuguese Universities. One of the outcomes from this R&D experience is the possibility to explore new business directions and develop medical devices for physical medicine and rehabilitation in the near future.

Exatronic is a vertical company that works with different markets, encompassing different skills during the development of new products based on electronics. From idea inception to product delivery and after sale support, Exatronic is present across the entire product lifecycle.

Exatronic works in the automotive sector, mobile telecomm infrastructure, and industrial machine interfaces (HMI). In 2008, Exatronic entered the healthcare sector through the development of the electronic medical devices.

(Exatronic, 4 May 2010)