Vigmed granted Quality System Certification


Vigmed, having completed the establishment of a Quality Management System, and
has now been granted Quality System Certificate for both EN ISO 13485:2012 and
EN ISO ISO9001:2008 (issued by Presafe A/S). The scope of the Certification
includes development & manufacturing of solutions to prevent needle stick
injuries.

The 13485:2012 standard includes Quality Management System requirements for
medical devices specifically for regulatory purposes. It is based on the ISO9001
standard and is also harmonized with FDA regulations. It provides a framework
for a manufacturer to meet the Quality System Requirements for the registration
of medical devices.

“The certification for the 13485 and 9001 standards supports Vigmed’s ambitions
to launch a new product every year, and will provide further assurance that
Vigmed management processes will constantly evolve and improve in regards to
both effectiveness and efficiency”, says CEO Finn Ketler.
For further information contact:

CEO, Finn Ketler 46 42 600 5311 or DIRECTOR, QA & RA, Ola Lindau +46 42 600 5315
Vigmed is a Swedish medical technology company whose mission is to eliminate
needlestick injuries by offering the market unique needle-protected products.
Vigmed is headquartered in Helsingborg, Sweden, and has approximately 15
employees. Vigmed’s share is traded on NASDAQ OMX First North in Stockholm
(ticker VIG) and has approximately 5 400 shareholders. Remium Nordic AB is the
Company’s Certified Advisor.

Additional information such as company description, a video presentation and
risk factors can be found on Vigmed’s website: www.vigmed.com/investor

Attachments

07164484.pdf