ISO 13485 Certified Agency

Medical device development produced to internationally recognised quality standards.

Blue Frontier is an ISO 13485 certified digital agency.

We work hard to maintain an internationally recognised standard to be a trusted partner for organisations looking to develop top quality medical devices for private and public health.

Easier to Outsource

Because we are an ISO 13485 certified agency, we’re already using the processes and systems that most organisations require to ensure the quality of their medical devices.

Efficient Delivery

The processes and procedures we use ensure that development time is maximised. This means that we deliver great products on time.

Greater Risk Management

Choosing an ISO 13485 certified agency ensures reliability. Products will be delivered to a high standard and efficiently, because we’ll be working to a quality standard that expects this.

Building What You Want

Products are developed to your requirements. We run each project in accordance with the Blue Frontier ‘Project Delivery’ standard operating procedure. This ensures that all work fulfils client expectations.

Our Experience

Our developers collaborated with Alere in the development of a web-based platform for screening and monitoring HIV in sub-Saharan Africa. They required a product that could collect, collate and analyse test data from diagnostics devices.

We continue to work with Alere to maintain and develop the product. The platform now supports more devices and is being implemented for point-of-care HIV detection across Africa, Asia and South America.

Why Us?

We have a dedicated team of in-house specialists who will work with you to build platforms and systems to improve workflows and better the processes that are being used by health centres across the globe. The benefits of working with an ISO certified agency is that we are working to an internationally recognised standard of quality management, so you can have confidence in the end product.

Current Projects

As an ISO 13485 certified agency, we are a reliable partner for many organisations looking to develop medical devices. Currently, we are working with organisations in the development of connected health platforms. Connected health uses technology to reduce lead times on patient diagnosis by getting medical data to clinicians faster. This speeds up treatment delivery to patients. Our work is positively changing lives by helping patients and clinicians make better decisions during treatment.

And there are benefits for manufacturers too. Manufacturers are better able to monitor devices and collate transmitted data for analysis. This means that they can ensure quality, precision and consistency in real time.

Tell us about your project

To find out more about our services and how we can help your business, please get in touch.