Audit and Compliance

We support full audit readiness and QMS compliance under ISO 13485, FDA QMSR, MDSAP and the Geography specific QMS and/or GMP. We perform gap assessments for the existing documents of the organization for Quality Management System, provide remediation, update the documents and make it for audit readiness.  

We committed for the QMS establishment, implementation and continuous improvement by considering "patient safety is utmost priority" by providing below services. 

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Services; 

• Guidance on QMS Establishment and Implementation.

• Quality Procedures and Instructions Creation. 

• QMSR, QMS, MDSAP Audit Readiness & Mock Audits

• Supplier & Contract Manufacturer Audits

• EU MDR Compliance 

• Documents & Records Creation

• CAPA, Nonconformity, Risk Management and Change Management.  

• Non Conformance Remediation Support