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ISO Certifications

ISO Certifications

Each site follows strict Quality Control and product release protocols, which coupled with effective Quality Assurance processes ensure our products meet stringent product quality, safety and customer requirements.

Our business success, is proof of our commitment to compliance and customer service and further demonstrated by our certified Quality Management Systems.

You will find links to our ISO certifications in the table below:




Quality Policy

Cape Town SA

ISO 13485:2016 certificate


ISO 13485:2016 certificate

Porton Down ISO 13485:2016 certificate


ISO 13485:2016 certificate


ISO 13485:2016 certificate

Portland, Maine

ISO 13485:2016 certificate


ISO_9001:2015 certificate

ISO_13485:2016 certificate

If you have a query regarding BBI Solutions’ compliance status, please contact our Quality Assurance Team

BBI Solutions Brands


The acquisition of DIARECT in June 2020 and their world leading recombinant autoimmune antigen capability immediately enhances BBI’s portfolio and position as a ‘complete’ immunoassay reagent supplier. This further enhances BBI’s position as the world’s largest diagnostics components company with a market leading antigen portfolio.


Maine Biotechnology Services brings 27 years of knowledge, experience, process development, and project management to our customers to ensure the best possible antibodies for any application. As antibody development goals in the biotechnology and pharmaceutical industry have evolved the acquisition of MBS will help BBI further meet and exceed our customers needs.


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