ISO 13485 Certification Medical Devices Quality Management
Why ISO 13485 Certification Medical Devices Quality Management is important?
In the medical devices industry, safety and quality are non-negotiable. Regulatory requirements are increasing at every step of a product’s life cycle and public scrutiny is intensifying.
ISO 13485 is the internationally recognized industry-specific standard for quality management systems. It is designed and intended for organizations involved in related to design and development, production, installation, servicing and sales of medical devices. A certified organization proves its ability to provide medical devices and that related services consistently meet customer and applicable regulatory requirements.
ISO 13485 provides a practical foundation for manufacturers to address regulations and responsibilities as well as demonstrating their commitment to safety and quality. As a quality management system standard, it is not product specific, but covers processes relevant to the production of medical devices and related services.
Legal market access for products is essential for medical device manufacturers. National regulations often require ISO 13485 as part of the approval process for medical devices.
Demonstrating proficiency in delivering quality products or services that meet customer and regulatory requirements is crucial for success. Consistency builds reputation and gives a competitive edge. Meeting customer expectations and industry regulations is necessary to gain customer trust and loyalty, resulting in increased revenue. Prioritizing customer and regulatory requirements and ensuring team alignment is key to building a successful and sustainable business and earning a trusted professional reputation.
Benefits of ISO 13485 Certification Medical Devices Quality Management Certification
While beneficial for any manufacturer, ISO 13485 implementation and certification is a very good starting point for companies seeking to enter the medical device industry.
Some of the specific benefits include:
Step by step ISO 13485 Certification Process
STEP 1
APPLICATION AND CONTRACT
STEP 2
OPTIONAL PRE-ASSESSMENT
STEP 3
STAGE 1 AUDIT
STEP 4
CERTIFICATION AUDIT
STEP 5
YEARS 2 & 3: CERTIFICATION MAINTENANCE
STEP 6
RE-CERTIFICATION
