Quality Management

Our quality management approach is solution-oriented. We ensure development initiatives can reach the finish line while holding a high standard of product quality and system compliance.

• Implementation of Quality Management Systems compliant with ISO 13485

• Audit preparation for FDA, ISO 13485 by Notified Body, CE marking, Medical Device Single Audit Program (MDSAP), and other region-specific authorities

• Establishing and maintaining standard operating procedures (SOPs)

• Product life cycle management, including post-market surveillance and reporting of adverse events

• CAPA support

• Change control