Our Services CDSCO Regulatory Consultancy End-to-end support for medical device registration, import license, and manufacturing license as per CDSCO guidelines. ISO 13485 Certification Complete implementation and certification support for medical device quality management systems. ISO 9001 Certification Establish efficient quality management systems to improve performance and customer satisfaction. ISO 14971 Risk Management Risk analysis, evaluation, and control for medical devices as per international standards. CE Marking Consultancy Guidance for European compliance including technical documentation and MDR requirements. BIS Certification Support for BIS approval including product testing, documentation, and certification process. ZED Certification (MSME) Enhance manufacturing quality and sustainability through ZED certification. Technical Documentation & DMF Preparation Preparation of Device Master File, STED, and regulatory documentation. Internal Audit & Training We conduct professional audits and training programs to ensure compliance and readiness for certification. Regulatory Strategy & Compliance Support We provide strategic consulting to help businesses plan regulatory pathways and market entry.
