Bannick Consulting Alliance, LLC
Getting it done right. Now. Since 1998.
Establish and maintain Quality Systems compliant with FDA QSR and ISO 13485:2016.
Create and implement Quality System procedures: documentation control, design control, CAPA, complaint handling, management review, purchasing, receiving, calibration, internal and external auditing, and inspection.
Quality Auditing: internal (FDA QSR and ISO 13485:2016), supplier, ISO 13485:2016 and MDSAP GAP assessment.
ISO 13485:2016 transition.
just north of Minneapolis, MN