Healthcare industries are now beginning to require International Organisation for Standardisation (ISO) certification from their medical device manufacturers.
As a result, MinXray announced that it had been awarded ISO13485:2016 Certification on 2st April, 2022.
This certification ensures compliance with internationally recognised best practices and safety protocols.
MinXray supplies portable, compact digital imaging equipment to the cruise industry.
The company’s Director of Technical and Customer Support, Ed Dubbs, commented that MinXray was already doing well before the audit, adding: “We had the details and data required to document adherence to regulatory codes. The audit and subsequent certification gave us added insight into our company’s conformance.”
ISO 13485 is a quality management system for medical device/component manufacturers, the company explained.
This includes any organisation that designs, produces, installs, or services medical devices and components. As a globally recognised standard, ISO 13485:2016 makes product conformity possible amidst expanding international supply chains, the company said.
The company also stressed that due to the vital nature of these products, conformity is paramount for reducing risk and increasing customer satisfaction.
To earn the certificate, MinXray had to demonstrate to a third-party registrar via a certification audit that its quality assurance processes consistently provide devices that meet both customer requests and applicable regulatory requirements.
Dubbs added: “The challenge now is to keep MinXray focused on what we do well, while being mindful of our deeper understanding of who we are and how we can be better.”