Quality Management System
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Implementation and/or maintenance of a QMS meeting the requirements of EN ISO 13485:2016, ISO 9001:2015, 21 CFR Part 820 or MDSAP.
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Validation covering devices and equipment.
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Complaints and Recalls.
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Support during QMS regulatory authority audits from preparation to execution to audit response.
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Supplier audits.
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Internal audits.
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Mock inspections.
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Remediation programs.
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Root Cause Analysis and CAPA.