Participate in development of the most efficient way to use QMS to meet regulatory expectations. Create a system that can meet audit ready standards. Simplify design controls so they provide the least amount of friction to the developers and development pathways. Reimagine how QMS can be achieved using to meet the compliance requirement. Participate in experimenting approaches for capturing software changes, design controls to comply with regulatory requirements. Show the defensibility and reliability of QMS data to internal stakeholders and external health authorities and auditors.
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