Certifications


Certifications

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:

 

  1. 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.
  2. Compliance with Regulatory Requirements: ISO 13485 aligns with regulatory requirements in the medical device industry, helping organizations ensure conformity to relevant laws and regulations.
  3. 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.
  4. Traceability and Documentation: Emphasizes the importance of maintaining comprehensive documentation, including records of processes, procedures, and actions taken to ensure traceability and accountability.
  5. 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:

 

  1. Regulatory Approval: CDSCO is responsible for the approval and regulation of pharmaceuticals, medical devices, biologicals, and clinical trials in India.
  2. Setting Standards: The organization establishes and revises standards for drugs, medical devices, cosmetics, and clinical trials to ensure compliance with global quality benchmarks.
  3. 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.
  4. Regulatory Framework Development: It develops and updates regulatory policies, guidelines, and procedures to align with international best practices and ensure the continuous improvement.
  5. Collaboration: collaborates with national and international organizations, regulatory bodies, and stakeholders to promote harmonization, exchange of information, and capacity building.
  6. 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.

Certificate

Certificate

Contact Us

Euromedix Healthcare

y No. 42/4, Ward No 12 Hosur Main Road, Chandapura, Bangalore, Karnataka - 560099, India

Mobile : +91-8436108108, +91-9119118430

Call Us : 08048778582

E-mail : info@euromedix.in



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