Consultant Resources

ISO 13485 outlines criteria for establishing a comprehensive quality management system for medical devices. It guides organizations in meeting regulatory requirements, ensuring product safety, and maintaining efficient processes across the device’s life cycle, from design and production to post-market activities.

MDR 2017/245 is an EU regulation setting forth stringent standards for the safety, performance, and quality of medical devices. It defines the regulatory framework, ensuring conformity and traceability throughout the supply chain, emphasizing patient safety and public health.

ISO 14971 provides a systematic approach to managing risks associated with medical devices. It guides manufacturers in identifying, evaluating, and mitigating potential hazards, ensuring a proactive risk management process throughout the device life cycle, fostering patient safety.

ISO 10993 establishes a framework for assessing the biological safety of medical devices. It outlines testing methods to evaluate potential adverse effects on living tissues, addressing concerns related to cytotoxicity, genotoxicity, and other biological risks to ensure device biocompatibility.

IEC 62304 outlines software life cycle processes specific to medical devices. It defines requirements for software development, validation, and maintenance, ensuring the safety and effectiveness of medical device software throughout its life cycle, from conception to retirement.

MEDDEV 2.7.1 provides guidance on conducting clinical evaluations of medical devices in accordance with EU directives. It assists manufacturers and notified bodies in planning, conducting, and documenting clinical evaluations, ensuring compliance with regulatory requirements and patient safety.