ISO 13485 / 9001 accreditation

L2S2 passes major ISO audit

L2S2 was assessed by BSI on 29 April 2016 and found to be fully compliant.  We have been accredited as a critical supplier and manufacturer to:

Medical device standards, EN ISO 13485:2012, ISO 13485:2003, ISO 13485 and quality standard ISO 9001:2008.
Xenplate can also meet FDA 21 CFR Part 11 requirements.
L2S2’s ISO 13485 scope of registration includes:
Design and development, manufacture, installation and service of mobile data platform software and integrated apps, data collection and review software, audit software, automated image inspection software, PACS analysis software,document management system software, pharmaceutical drug registration submission system software, medical diagnosis tools utilizing medical models and computer algorithms, software interfaces to existing hospital systems, mobile medical devices, (Apps), to be used by medical staff and patients, interfaces to primary care systems, primary diagnosis aids based on computer and medical models.
Design and development, manufacture, installation and service of mobile data platform software and integrated apps,data collection and review software and audit software.