Certifications
Euromedix Healthcare (Revelex Medtech Pvt Ltd) is an ISO 13485 & GMP certified company for the design, development, production, installation, and servicing of medical devices. We are also a licensed manufacturer of Class A & B medical devices from the CDSCO (Central Drugs Standard Control Organization)
Key aspects of ISO 13485 include:
- Focus on Quality Management: Emphasizes the establishment, implementation, and maintenance of a quality management system to ensure the consistent design, development, production, and delivery of safe and effective medical devices.
- Compliance with Regulatory Requirements: ISO 13485 aligns with regulatory requirements in the medical device industry, helping organizations ensure conformity to relevant laws and regulations.
- Risk Management: It requires organizations to identify and manage risks throughout the product lifecycle, from design and development to post-market surveillance and improvement processes.
- Traceability and Documentation: Emphasizes the importance of maintaining comprehensive documentation, including records of processes, procedures, and actions taken to ensure traceability and accountability.
- Continual Improvement: Continuous improvement is a fundamental aspect of ISO 13485. Organizations are expected to regularly monitor and evaluate their processes, aiming for ongoing enhancement of their quality management system.
Key functions of CDSCO include:
- Regulatory Approval: CDSCO is responsible for the approval and regulation of pharmaceuticals, medical devices, biologicals, and clinical trials in India.
- Setting Standards: The organization establishes and revises standards for drugs, medical devices, cosmetics, and clinical trials to ensure compliance with global quality benchmarks.
- Monitoring and Surveillance: Conducts post-market surveillance, inspections, and monitoring activities to ensure compliance with regulatory standards, addressing issues related to quality, safety, and efficacy of regulated products.
- Regulatory Framework Development: It develops and updates regulatory policies, guidelines, and procedures to align with international best practices and ensure the continuous improvement.
- Collaboration: collaborates with national and international organizations, regulatory bodies, and stakeholders to promote harmonization, exchange of information, and capacity building.
- Quality: plays a pivotal role in safeguarding public health by regulating and overseeing the quality, safety, and efficacy of pharmaceuticals, medical devices, and related products in India.
