Category: Quality and regulation

The ISO 13485 standard specifies requirements for a quality management system (QMS) in organizations involved in the design, development, production, installation, and servicing of medical devices. It focuses on developing a robust QMS, comprehensive documentation, risk-based thinking, and continuous improvement. The standard addresses the full product lifecycle, emphasizing patient safety and regulatory compliance. Standards like […]

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Internal auditing in accordance with ISO 13485 is a systematic and objective evaluation of how well an organization’s quality management system is functioning. It ensures compliance, identifies areas for improvement, and supports continuous improvement within a health technology company. The audit process consists of planning, execution, and follow-up phases. What does internal auditing mean in […]

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Excluding risk class I devices, notified body auditing is an essential process in the health technology field, where a third party evaluates a company’s quality system and documentation for compliance with MDR requirements. The most common challenges relate to documentation management, deficiencies in risk management, and inadequate staff preparation for the auditing situation. What does notified body […]

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A Quality Management System (QMS) is an essential framework for medical devices that ensures product safety and compliance with regulatory requirements. It encompasses documented processes, risk management, and continuous improvement methods. A functioning QMS is a prerequisite for CE marking and market access in Europe. What is a QMS and why is it essential for […]

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When is CE marking mandatory for medical devices? CE marking is mandatory for all medical devices placed on the EU market that fall within the scope of the Medical Device Regulation (MDR). The marking demonstrates that the device meets safety and performance requirements. The only exceptions are custom-made devices and devices used in clinical investigations. […]

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