ISO 13485 Quality Management Implementation

Providing consultancy and training for establishing a compliant quality management system under ISO 13485, preparing for certification audits, and continuous regulatory compliance management.

A. Quality Management Systems (QMS)

Our quality and compliance specialists have extensive knowledge and experience in relevant regulations, guidances, and best practices related to quality system management throughout the regulated life science industries.

• GxP Audits

• QMS Process & Procedure Development

• Gap Assessments

• QMS Remediation

• Quality Unit Resourcing

B. Non-Conformance & CAPA Management

Our quality, manufacturing, CAPA, and supplier quality experts conduct comprehensive process reviews and analyses to ensure all compliance gaps are closed no matter where they may be.

• Non-Conformance/Deviation Investigation Management Support

• Process Analysis & Enhancement

• Investigation, Action Plan, & Effectiveness Check

C. Regulatory Compliance

Move your organization forward while maintaining a continuous and complete state of regulatory compliance. From regulatory observation responses to inspection readiness, our large staff of compliance specialists can tackle virtually any regulatory challenge.

• Regulatory Observation Responses & Remediation

• PAI & Inspection Readiness

• Internal Audit & Remediation Services