MEDICAL SERVICES MANUFACTURING – ISO 13485

Certification to ISO 13485 provides assurance that the organization manufacturing medical devices fulfils the standard requirements for designing, production, installation, and servicing. Organizations use it to control the processes to meet the desired results for end products including applicable regulatory requirements.

ISO 13485 is the medical device industry’s most widely used international standard for quality management. Issued by the International Organization for Standardization (ISO), the ISO 13485 standard is an effective solution to meet the comprehensive requirements for a Quality Management System in the medical device industry.

Compliance to ISO 13485 validates a company’s commitment to produce safe and effective medical devices. Standard also helps companies meet regulatory requirements in many markets around the globe. ISO 13485 can help companies identifying  and mitigate risks associated with the design, development, and production of medical devices. Finally, it can help companies improve their processes and increase efficiency, leading to better products and higher customer satisfaction.

From design to installation, implementing a quality management system is crucial for medical device manufacturing organisations at every stage.  ISO 13485 enables manufacturers to continually meet customer expectations and prevent risks associated with poor-quality processes while continually improving product specifics.