InsightsPressBond meets strict international medical device standards

Bond meets strict international medical device standards

Bond Digital Health is proud to announce that its quality management system officially complies with strict international standards for medical devices.

Independent auditors this week confirmed that Bond has gained ISO 13485:2016 certification.

Issued by the International Organization for Standardisation (ISO), ISO 13485 is the medical device industry’s most widely used international standard for quality management.

Certification means that the quality management system Bond has put in place for the design, development, manufacture, and maintenance of Transform®, its data capture and reporting platform for lateral flow tests, meets internationally recognised requirements.

For Bond’s clients and partners, many of whom work in highly regulated environments, it reduces their own risk and gives them additional confidence.

It will allow Bond’s customers to focus on their work, safe in the knowledge that they are working with a company that understands the regulatory requirements.

Certification also differentiates Transform® from other products on the market, especially new and non-certified systems that have been developed quickly to capitalise on the Covid-19 demand.

Ian Smith, Bond’s CEO, said: “This is a huge achievement for the business, as it proves we comply with the requirements for a comprehensive quality management system for the design and manufacture of medical devices and specifically in our case, supporting software.

“This independent, external recognition of our hard work demonstrates to our clients that we are aware of the regulations that relate to them and reassures them we take quality, safety and regulatory compliance seriously. 

Viktoriya Agova, Bond’s Marketing Manager, said: “This certification exemplifies all the great things about our culture – from our commitment to quality and development best practice to the knowledge and expertise of our people.”

Phil Cooley, Bond’s Quality Manager, has overseen the work to gain the accreditation over the last two years.

He said: “Reaching this significant milestone should be seen as a company achievement, as we wouldn’t have gained the accreditation without the hard work and commitment of the entire team.

“But that doesn’t end now we have the certification – we have to keep working hard to maintain the standard.”

Bond will undergo a full re-audit in three years’ time.