Biovotec has been awarded certification to the international quality standard ISO13485 by BSI
Following inspections at its facilities in Oslo and Dublin, Biovotec has been awarded certification to the international quality standard ISO13485: Medical devices – Quality management systems – Requirements for regulatory purposes. With the certification to ISO13485, Biovotec has successfully achieved one of the pre-requisites for marketing.
Our certification was achieved through The British Standards Institution (BSI) which was formed in 1901 and is the oldest standards organization in the world.
The certification of Biovotec to ISO13485 by BSI is a significant external endorsement of the quality goals, technical expertise and management expertise of the company.
We look forward to the next stages of the process in bringing our first product to market.