53Biologics Awarded ISO 13485 Certification for Quality Management System

53Biologics, a leading biopharmaceutical contract development and manufacturing organization (CDMO), is proud to announce that it has been awarded ISO 13485 certification for its quality management system. This prestigious certification demonstrates the company’s commitment to quality and to meeting the highest international standards for medical devices.


ISO 13485 is an international standard that specifies requirements for a quality management system for organizations involved in the design, development, production, installation, and servicing of medical devices. This certification requires a comprehensive quality management system in place, which includes processes for risk management, design and development, production and service provision, and continuous improvement.


Obtaining ISO 13485 certification is a significant achievement for 53Biologics and demonstrates the company’s dedication to ensuring that its processes and procedures meet the highest standards of quality and reliability. By obtaining this certification, 53Biologics has demonstrated its commitment to providing high-quality products and services that meet the specific requirements of its customers.


We are thrilled to have been awarded ISO 13485 certification,” said Andrea García, the Quality Assurance director at 53Biologics. “This achievement is a testament to our commitment to quality and to our customers. We understand that the products and services we provide are critical to the healthcare industry, and we take this responsibility very seriously.


This certification also demonstrates 53Biologics’ commitment to regulatory compliance. The healthcare industry is highly regulated, and compliance is essential for ensuring patient safety and product efficacy. By obtaining ISO 13485 certification, 53Biologics has demonstrated that it has a quality management system that meets regulatory requirements.


53Biologics believes that quality is not just a goal; it is a way of life. The company is constantly looking for ways to improve its processes and procedures to provide better services to its customers. The ISO 13485 certification is just one example of 53Biologics commitment to quality, and the company will continue to strive for excellence in everything it does.


About 53Biologics:

53Biologics is a CDMO with extensive experience in biologics production. The company offers a range of services for the biopharma industry, including process development, clinical manufacturing and analytical testing, to support every step up to commercialization of biotherapeutics.


For more information on the company and its services, please visit 53Biologics.com.



Patricia De La Madrid

Marketing & Business Development Manager at 53Biologics



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