Quality Compliance

Current and upcoming health and environmental regulatory requirements mandate compliance by manufacturers, suppliers, retailers, and distributors across the globe. We assist in the design and implementation of Quality Management Systems that comply with FDA QSR, ISO standards, European Medical Device Directives, and other medical device authorities’ requirements. We make sure through administrative and procedural activities implemented in a quality system that your medical device meets the specifications and requirements.

We offer an ISO 13485 (2016) lead-auditor to audit your QMS and the following services:

• Quality System development (Manual and SOPs)

• Writing technical files, design history files, and product submissions incl. design dossiers.

• Establish- CAPA, Training, Labeling, Document Control and Internal Audit systems

• Gap Analysis - assessment of your existing compliance with the current applicable requirements

• Providing product safety and efficacy evaluations