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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
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