Quality

Quality Management System (QMS):

Establishment & preparation for certification of Quality Management System and Maintenance in accordance with ISO 13485:2016 (Quality Management for Medical Devices), ISO 9001:2015 (Quality Management System)
Implementing FDA Quality System requirements (QSR)
Implementing Canadian medical device requirments (MDSAP)

Audits:

Performing internal and supplier’s audits
Preparation and accompaniment for certification audits according to the standard (ISO 9001:2015 and ISO 13485:2016)
Preparation and accompaniment for certification audits according to MDSAP (Medical Device Single Audit Program)
Preparation and accompaniment for FDA inspection