Our Services
Good Manufacturing Practice for Medical Devices (CPAKB)
About this service
Ensuring medical products meet safety, quality, and effectiveness standards according to applicable regulations. This service includes comprehensive audits and assessments of production processes and quality management systems, as well as training programs for employees on implementing CPAKB principles. We also assist in developing and maintaining essential documentation, implementing effective quality management systems, and preparing for certification to meet CPAKB requirements. With CPAKB services, companies can increase customer trust, minimize risks, and ensure that medical products produced comply with local and international standards. We are committed to supporting clients in creating a safe and high-quality production environment, aligned with the latest technological developments and regulations in the medical industry.
What you get
Assistance in preparing CPAKB documents according to Ministry of Health standards.
Technical guidance related to production facilities and process validation.
Internal audit simulation before the official inspection.
Monitoring of submission progress until the CPAKB certificate is issued.
Direct consultation with regulatory and QA expert teams.
Requirements
Download AttachmentAdministrative Data
Documents for facilities, infrastructure, and production equipment.
Production quality management system documents.
CPAKB self-assessment.
Data and qualifications of key personnel (especially production PIC).
Declaration and commitment letter for CPAKB compliance.
