Quality Management System (QMS) & Global Regulatory Services

Quality Management System (QMS)

What is MDQMS/ISO 13485 certification?

ISO 13485 is an internationally recognised standard which demonstrate the requirements for Medical Device Quality Management System (MDQMS) for the organizations who are involved in design and development, manufacturing, distribution, installation and servicing of medical device.

ISO 13485 specifies requirements for good management practices in order to have a high probability to achieve quality, but without referencing any particular type of product.

Medical Device Quality Management System (MDQMS), is a documented set of interrelated processes which establish, implement and maintain the customer and applicable regulatory requirement for Medical device Organizations. These processes and their interactions are subject for improvement to achieve quality objectives.

Implementation of a QMS should not result in excessive bureaucracy, paperwork, or lack of flexibility nor should your QMS be an unreasonable financial burden. Expenditures relating to implementing and maintaining a QMS should be considered an investment with a return in the form of benefits and improvements.

Benefits of ISO 13485 Certification For Medical Devices and IVDs

• Improve organization performance: Establishes a systematic approach for managing interrelated processes to achieve quality objectives and provide a basis for sustainable business development initiatives.
• Enhance customer confidence: Consistently delivering safe, reliable, and high-quality medical devices which helps manufacturers to strengthen trust, build lasting relationships, and enhance credibility with healthcare professionals and healthcare organizations.
• Support for stronger regulatory compliance: Helps medical device organizations to establish processes that support applicable regulatory requirements and consistently meet customer requirements.
• Maintain continuous product quality: ISO 13485 certification supports the medical device consistently meets regulatory, safety and performance requirements throughout the product lifecycle, from design and development to manufacturing, distribution, and post-market surveillance.
• Risk-Based Quality Control: Strengthens supplier management and risk control processes to minimize potential quality issues, regulatory noncompliance, nonconformities, customer complaints, and product recalls.
• Strengthened Market Opportunities: Demonstrates the conformity with an internationally recognized medical device QMS standard, helping organizations to meet continuous customer requirements in global markets.
• Compliance with global regulatory requirements: Establishes a robust Quality Management System that supports the alignment of regulatory requirements across international markets, including MDSAP, EU MDR, EU IVDR, QMSR.