As a maker of quality medical equipment who wishes to offer safe and effective products, having in place an ironclad quality management system (QMS) that adheres to approved regulatory standards is very necessary. Ever since its inception and approval by the global harmonization task force (GHTF), ISO 13485 has rapidly evolved into the gold standard in the healthcare equipment industry. Below are some of the most notable benefits of being ISO 13485 certified, you should know.
Benefits of being ISO 13485 certified
Unlimited access to lucrative global markets
The ISO 13485 standard is universally recognized by virtually all main medical equipment markets globally. This, of course, includes the US, Europe, Australia and Japan. As you may probably be aware, most governmental regulatory agencies in this industry have stringent regulations.
One of this is requiring private companies who make healthcare devices to possess a 3rd party audited and certified QMS set …