Tailored QMS framework for innovative consumable reagent kit to comply with cell and gene therapy companies

Important results from the project

Countagen develops, patents and commercializes reagent kits and consumables for the cell and gene editing market. With the goal to scale up and address the needs of biotech and pharma companies we have set up a tailored QMS by identifying our processes, producing Standard Operating Procedures (SOPs) and implementing a selection of them.

Expected long term effects

The implementation of the ISO 13485:2016 Quality Management System for Medical Devices is expected to get Countagen access to the gene and cell therapy markets as a whole. Our current products are research use only, focussing on the early research and development phase of CGT. In the near future we want to address the whole CGT development pipeline spanning preclinical and clinical phases.

Approach and implementation

The project consisted of seven phases and they were carried out in collaboration with Plantvision. The first two steps consisted in the needs analysis and the scope identification after which a project was defined. On the next step, the consultants at Planvision drafted Standard Operating Procedures (SOPs) and Countagen personnel completed the documents. Follow up meetings were scheduled for iterations and a final hand over meeting was held.