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The Transition to ISO 13485:2016 – Clearbridge BioMedics X Stendard

Clearbridge BioMedics

Clearbridge BioMedics Pte Ltd is a cancer diagnostics solutions company that develops and manufactures liquid biopsy systems. Clearbridge BioMedics has won numerous awards and garnered global recognition for its novel Circulating Tumour Cell (CTC) detection platform technology, the ClearCell® FX1 System. 

ClearCell® FX System

The ClearCell® FX System and its biochip are utilising state-of-the-art, non-invasive liquid biopsy to process blood samples for enrichment of CTCs. The device enables the real-time analysis of disease before, during, and after treatment, which has become increasingly critical in the new era of targeted cancer therapies. Clearbridge BioMedics has received ISO 13485 certification in 2011 and the ClearCell® FX1 System attained CE IVD in 2015.

We had the opportunity to speak to Mr Danny Tan, the Management Representative of Clearbridge BioMedics, about the obstacles they faced while doing the ISO 13485 transition to the new ISO 13485:2016 version and his personal experience with Stendard First™.

Transition to ISO 13485:2016

With the rollout of the new ISO 13485:2016, the ISO 13485:2003 certification is no longer acceptable by March 2019. Recognising this requirement as a potential obstacle to their operation, Danny and his team committed their full dedication towards updating their processes to meet the new ISO 13485:2016.

“A lot of new requirements have been added, so it is recommended to identify these gaps as early as possible”, CEO of Stendard, Mr Jason Lim mentioned.

Stendard First™

“With Stendard First™, it definitely makes it easier for us to realise the gaps we needed to bridge as we are unfamiliar with the ISO 13485:2016 requirements, and we managed to generate all the documents that we need within an hour of use.

— Mr Danny Tan, Management Representative of Clearbridge BioMedics

Regarding the speed of content generation, COO of Stendard, Mr Vincent Lim elaborated, “The way we designed the Stendard First™ platform is to generate an elaborate set of customised documents for each company, focusing on time and cost savings for our clients. These 70 over documents includes the Quality Manual, Procedures, Forms and Work Instructions, and without spending half a day of use.”

Smoothening the Transition Process

Having all the valuable feedback from Danny and his team, as well as other companies in the transition phase, the Stendard team is pleased to announce a new feature designed specially to help transition companies move from ISO 13485:2003 to ISO 13485:2016 with ease.

This new feature will include various checklists and highlighted contents in each document to focus on the newly added clauses spelt out in ISO 13485:2016. This feature will be launched in early-2018, in time to help medical device companies transit to the new ISO 13485:2016 by the deadline.

Moving Forward

Every year, among the 38,000 ISO 13485:2016 certifications issued worldwide, there are many just like Danny and his team, who needs the support and added assurance to their documentation before their transition audit. One word of advice, try out Stendard First™.

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