When working in the medical device industry, it is crucial to keep up on any changes in regulations. Products are constantly evolving, which means safety and quality management systems need to be a top priority. Make sure your company has the best management systems in place by earning an ISO 13485 certification in Utah.
What Is an ISO 13485 Certification?
The International Organization for Standardization (ISO) set regulatory requirements for quality management systems in the medical device industry. The ISO 13485 certification shows that your company has quality management systems that comply with these multi-national standards for medical device manufacturing. This also applies to subcontractors, specialized consulting firms, suppliers, and others that work in a capacity associated with medical device manufacturing.
Benefits of ISO 13485 in Utah
In addition to the comfort and satisfaction of knowing you are producing safe, high-quality devices for use in the medical field, there are multiple benefits to earning an ISO 13485 certification.
- Products and processes are always under review, which means faster production and better service.
- Areas of waste will be identified and eliminated. This includes overproduction, lag time, defects, and more.
- Communication is improved by a shared understanding of terminology and processes, making it easier to identify areas that need improvement and implement the appropriate changes to processes.
- Increased efficiency and decreased waste mean lower production costs.
- Better quality management systems mean higher quality products, which equals higher customer satisfaction.
- Your company will enjoy the prestige of achieving recognized excellence in compliance with ISO 13485 standards.
- You will be able to expand your sales market to include Australia, Japan, Brazil, Canada, and the US.