ReAgent Has Been Accredited to ISO 13485

14th August 2019

Company News

ReAgent has been accredited to ISO 13485 - making in vitro diagnostic reagents for medical devices

We are very proud to announce that on 8th August 2019, ReAgent achieved ISO 13485 accreditation. This international ISO standard demonstrates that we meet the stringent requirements of a quality management system specific to the medical devices industry.

What is ISO 13485?

ISO 13485 is a practical solution for companies that deal with in vitro diagnostics (IVDs) to comply with Medical Device Directives, regulations, and responsibilities. Companies accredited to this standard demonstrate that they are committed to the safety and quality of medical devices, and are able to provide medical devices, products related to medical devices, and associated services that constantly and consistently meet customer and relevant regulatory requirements. For ReAgent, this means we are accredited to supply bespoke in vitro diagnostic (IVD) reagents.

ReAgent meets the quality standard and is accredited to supply in vitro diagnostic reagents for medical devices

ReAgent is accredited to supply in vitro diagnostic reagents for medical devices

It is first and foremost a risk-based standard, with regulations around mitigating and controlling risk. For example, it’s important to think about the different operations and processes that take place, how they are managed, and potential outcomes.

The Path to Achieving ISO 13485

When we received an enquiry about a chemical formulation we knew we could make but which required us to hold the ISO 13485 standard as it was a product for use with medical devices, the ReAgent board gave the go-ahead to progress with attaining the standard.

We worked with an external ISO consultant to compile a gap analysis that identified the changes and updates ReAgent would need to make in order to comply with the ISO 13485 standard. We already held ISO 9001, which at the time was closely aligned with ISO 13485, so we were in a strong position.

During the accreditation process we moved into a new factory, and we passed the first phase of our ISO 13485 audit in March 2019 to the new ISO 13485:2016 standard. 

Between passing the first documentation phase and gaining full accreditation, we worked to align a diverse range of tasks across the business, including the implementation of policies and procedures, reviewing our manufacturing processes, record-keeping, and how we deal with an IVD-related customer enquiry.

ReAgent receives ISO 13485 accreditation for manufacturing IVD reagents for medical devices

Achieving ISO 13485 Accreditation

On receiving full accreditation, our CEO Richard Hudson said,

“Gaining ISO 13485 accreditation is a great achievement for ReAgent. It shows our high quality standards, provides credibility to our customers, and adds another string to our bow. I’m very proud of the team, who are committed to making ReAgent the best it can be for our customers.”

Our auditors were equally impressed especially with our new product realisation and implementation process. They were complimentary about our bespoke business management database system, our cleanroom packing area, and the way our whole team has a very clear understanding of what they do and why.

While we now hold this international standard, which for a first audit on a new system, process, and product is an achievement we can certainly be proud of, we will always keep working on improving what we do.  

What this accreditation means for ReAgent

Holding the ISO 13485 accreditation means that ReAgent’s customers requiring in vitro diagnostic reagents will have the peace of mind that the manufacturing processes and controls we have in place are suitable for chemical products used in medical devices. They will also have the assurance of quality and compliance, and be confident that ReAgent is a credible, trustworthy manufacturer of bespoke IVD reagents.

Contact our team for your in vitro diagnostic reagent requirements.