Quality, safety, and compliance form the backbone of all operations at KVMG MEDISAFE Pvt. Ltd.
Our manufacturing and quality systems are aligned with applicable Indian and international regulatory requirements to ensure product safety, performance, and traceability.

Key Compliance Areas

• CDSCO Compliance as per Medical Device Rules (MDR), India
• ISO 13485–based Quality Management System
• Batch-wise traceability and documentation
• In-process and final product inspection
• Controlled manufacturing environment (where applicable)
• Validation of critical manufacturing processes
• Supplier qualification and raw material testing

Quality Assurance Commitment

• Zero-tolerance approach to critical quality defects
• Continuous monitoring of process parameters
• Periodic internal audits and management reviews
• Ongoing training of production and quality personnel

Our objective is to ensure that every product leaving our facility is safe, reliable, and compliant, meeting the expectations of healthcare professionals and regulatory authorities alike.