Here is the English translation: How to Build a QMS System for Medical Devices? A QMS (Quality Management System) is an essential quality system for medical devices that ensures product safety and compliance with regulatory requirements. It includes documented processes, risk management, and continuous improvement methods. A functioning QMS is a prerequisite for CE marking […]
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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 audit situations. Notified body auditing is a systematic evaluation in which an authorized third-party organization examines a medical device manufacturer’s operational compliance with requirements. The primary purpose of auditing is to ensure that the company complies with the EU Medical Device Regulation (MDR 2017/745) and is capable of safely producing medical devices. Auditing is a central part of the CE marking approval process. Without successful auditing, a company cannot obtain the necessary certificate that authorizes the placing of products on the market in the European region. Health technology auditing focuses particularly on quality system functionality, risk management processes, and product documentation comprehensiveness. Meeting MDR requirements requires […]
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The key requirements of the ISO 13485 standard in healthcare technology focus on quality system development, documentation, risk management, and continuous improvement. The standard defines specific requirements for the design, manufacturing, and distribution of medical devices, emphasizing patient safety and regulatory compliance. Healthcare technology standards, such as ISO 13485, form the foundation for successful business operations in the industry. The ISO 13485 standard is an essential foundation for all companies manufacturing medical devices. The standard ensures that products meet international safety and effectiveness requirements before market entry. In the healthcare technology sector, patient safety is the primary priority. The ISO 13485 standard guarantees that every stage of the product development process is designed to minimize risks and maximize patient benefit. The standard integrates seamlessly with other healthcare technology standards, such as the IEC 62366 usability standard. Regulatory authority approval requires ISO 13485 certification in most countries. […]
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The landscape of medical device software regulation has evolved dramatically since the introduction of the Medical Device Regulation (MDR). With software increasingly becoming the backbone of modern healthcare technology, understanding how to properly classify and regulate these digital tools has become essential for manufacturers, developers, and regulatory professionals alike. The MDCG 2019-11 guidance document represents a crucial milestone in this journey, providing much-needed clarity on software classification requirements under the MDR framework. This comprehensive guidance addresses a fundamental question that has challenged the industry: how do we determine when software qualifies as a medical device and what regulatory obligations follow? […] […]
The frequency of audits in a health technology company is primarily determined by the requirements of the ISO 13485 standard and the MDR/IVDR regulations. Internal audits must be conducted in accordance with the audit plan defined in the quality management system. External audits performed by a notified body are carried out annually. The regularity of audits ensures the functionality and compliance of the quality management system. […]
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