- April 1, 2019
- Posted by: AXSource
Client Type: Medical Device, Software & Computer System Validation
Jurisdiction(s): EU & USA
Services Provided: Europe and US consultation and development of strategy document. Prepared procedures for compliance to ISO13485:2016 & EU Medical device Directive Essential Requirements. Provided guidance to client engineers in preparing device software validation documentation. Developed QMS procedures and reviewed technical and clinical documents.