A quality system is a regulatory requirement for medical device manufacturers. A company should interpret the requirements of the regulations and standards for itself and design a quality management system that satisfies the applicable requirements and which makes sense for their operations. 

QARA Consulting has extensive experience in developing, implementing and streamlining quality management systems. We can help you develop a quality management system that ensures regulatory requirements are met.

Person responsible for regulatory compliance

MDR requires that all Medical Device Responsible Manufacturers assign a Person Responsible for Regulatory Compliance.

If requested we can act as your company´s Person Responsible for Regulatory Compliance and take care of Post market Surveillance system, vigilance, post market clinical follow-up and update of the technical file.

Example of common tasks include:

• Strategic planning of designing a corporate quality management system to achieve compliance with QSR, ISO 13485, ISO 9001, MDD, IVDD, Health Canada MDR SOR/98-282
• Streamline the QMS to improve its efficiency 
• Internal audits