WELDON BIOTECH (INDIA) PRIVATE LIMITED completed the initial audit for IOAS-accredited ISO 13485:2016 Certification for Medical Devices – Quality Management System (MD–QMS).
The scope of the management system includes the Trading, Supply, Installation and After Sales Service of 3 Part Hematology Analyzer, Clinical Chemistry Analyzer, Electrolyte Analyzer and Fully Automatic Chemistry Analyzer.
WELDON BIOTECH (INDIA) PRIVATE LIMITED can apply for ISO 14001:2015 Certification for Environmental Management System (EMS) to adopt eco-friendly practices for sustainable growth. The organization can apply for Good Manufacturing Practices (GMP) compliance and ISO 45001:2018 Certification for Occupational Health and Safety Management System (OHSMS).
What is ISO 13485:2016 Certification?
ISO 13485 is an internationally recognized standard for quality management system (QMS) designed specifically for medical devices. The standard applies to organizations that are involved in the design, production, installation, servicing, and manufacturing of medical devices.
ISO 13485 standard provides a robust framework for risk management and enables them to identify and eliminate potential threats. It also ensures companies can maintain thorough documentation and traceability across the entire product lifecycle.
Benefits of ISO 13485:2016 standard for WELDON BIOTECH (INDIA) PRIVATE LIMITED
ISO 13485:2016 certification offers the following benefits for WELDON BIOTECH (INDIA) PRIVATE LIMITED. These are:
- ISO 13485 aligns with global regulatory requirements and supports WELDON BIOTECH (INDIA) PRIVATE LIMITED to meet the strict medical device standards required in global markets.
- ISO 13485 standard ensures WELDON BIOTECH (INDIA) PRIVATE LIMITED’s compliance with legal and quality guidelines to reduce legal issues and risks. It enables the organization to minimize product defects and ensure that medical devices are safe and effective for patients.
- ISO 13485 helps WELDON BIOTECH (INDIA) PRIVATE LIMITED optimize quality management processes by enhancing documentation and strengthening risk management to achieve greater operational consistency.
Conclusion
WELDON BIOTECH (INDIA) PRIVATE LIMITED received ISO 13485:2016 certification to demonstrate its dedication to regulatory compliance in the medical device industry. The standard improves the organization’s standing in the global market by ensuring the safety and effectiveness of its products.
 PRIVATE LIMITED for successfully completing the initial audit for IOAS-accredited ISO 13485:2016 Certification.){kind=link}