Promepla is certified ISO 13485 for medical devices and ISO 9001 for its quality management system (QMS). Our Quality department has developped a documented quality system that allows us to control every process of design, production and quality control. We can deliver products :

• CE marked (MDR compliance)
• and/or in compliance with FDA requirements
• and/or under Canadian License.

Our experts constantly monitor the changing national and international regulatory environments. We can provide expertise in the overall planning and execution of regulatory compliance through all phases of the product life cycle.

Learn more about our quality assurance & regulatory affairs services.