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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.
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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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