It was a great pleasure to be working with the team at National University of Singapore, Medical Engineering Research & Commercialization Initiative (MERCI) for the setup and implementation of a Quality Management System (QMS) based on ISO 13485.
MERCI’s mission is to drive the development and commercialization of medical devices in Singapore. The team is involved in several product development projects every year and they understand that implementing a quality system is crucial to the commercialization of medical devices. A QMS based on ISO 13485 will not only allow the team to stay compliant to industrial standards; a well designed system further ensures the team members communicate well with each other, raise productivity and overall output quality. Mr Melvin Loh, Director of MERCI said: “This certification is important for us to capture value in the projects we undertake and to assure our industrial partners and licensees of the quality of our work.”
We kick-started the project with a training conducted on the overview of ISO 13485 and ISO 14971 (risk management to medical devices). The objective is to get the team to understand the purpose of implementing a QMS and how it will help the team design a better medical device.
In the subsequent weeks, we met up with the team members from the various functions/roles handling procurement, business development, quality and regulatory affairs, product development and management to setup and document the internal processes. Understanding the team dynamics is key – so that the processes implemented are kept lean and relevant to the team.
We rolled out the implementation one month later after discussing with all members from the different functions. During this phase, we observed for any unsuitable or new workflow that needs to be amended or added respectively. The only way to know if something works is to try it first and then change accordingly!
As we got nearer to the certification audit, we provided training to selected members to be internal auditors. Internal audit was performed to observe for non-compliance. This is a good time to make correction to any mistakes that were unintentional and definitely a good trial for members that haven’t gone through the grilling of an audit before!
Finally, the team went through the two-day audit and succeeded in achieving the ISO 13485 certification. Congratulations!
As planned, we took six months through the phases from training, setting up, implementation, internal audit and completion of 3rd party audit. Throughout the project, we also ensure sufficient training and guidance are provided to everyone so that the team can continue to maintain their own implemented system post-audit. That’s our objective.
Interested to setup and implement a QMS for your company? Contact us now for more information, including a 30-minute complementary demonstration on how an eQMS platform can help you achieve better compliance and get to market faster!