Necessity and Confidence Building
Due to increased requirements from MDR and IVDR, especially due to changes in classification, the need to establish and maintain a Quality Management System (QMS) has become essential for manufacturers and distributors of medical devices and in-vitro diagnostic medical devices.
The manufacturer and distributors of medical devices are obliged to have their QMS audited and certified by a Notified Body before placing them on the market (exceptions made).
A quality management system enables the verification of the quality requirements throughout the life cycle. Originally, quality management systems were based on the ISO 9001 („Quality Management Systems. Requirements“) standard. However, medical devices are subject to their own sector-specific harmonized standard EN ISO 13485 („Medical devices. Quality management systems. Requirements for regulatory purposes“). By demonstrating that the quality management system is compliant with the EN ISO 13485 also proves that the medical device meets the basic requirements of quality assurance and is thus, a prerequisite for conformity assessment.
A quality management system unique to medical laboratories with specific requirements for the medical environment and the importance of the medical laboratory for patient care is covered in the international standard ISO 15189 Medical laboratories — Requirements for quality and competence.
Kalms Regulatory team supports you in setting up your appropriate QMS, including a comprehensive standards research, review of your documents, conducting a comprehensive gap analysis due to revisions of standards, as well as step-by-step guidance within the certification process. Kalms Consulting will guide you in a flexible and agile way to establish, implement and maintain your QMS with the corresponding compliant documentation.