A Comprehensive Approach: Integrating QMS and Data Security for Robust Medical Device Quality Assurance
The advancement of medical devices has revolutionized patient care and treatment outcomes.
The advancement of medical devices has revolutionized patient care and treatment outcomes.
In Vitro Diagnostic (IVD) devices play a crucial role in healthcare by providing valuable information for disease diagnosis, patient monitoring, and treatment decisions. The European Union's In Vitro Diagnostic Regulation (IVDR) 2017/746 introduced a new classification system for IVDs.
Complaint handling is an integral part of medical device companies’ Quality Management System (QMS). It involves receiving, investigating, and resolving customer complaints related to medical device products and services provided by an organization. Such complaints are related to the safety, performance, or effectiveness of medical devices, as per ISO 13485. Companies must address complaints promptly and effectively to maintain customer satisfaction and uphold Regulatory compliance.
The previous blog on the Fast-break Scheme (Part 1) discussed Japan’s conditional early approval system for innovative medical devices, covering four (04) essential steps, the rationale and requirements for the application review process, the eligibility criteria, the application submission process, the MHLW and PMDA’s Regulatory guidelines, the review process, eligibility without pre-development consultation, and the key considerations for describing eligibility summaries.
The safety and effectiveness of medical devices are of utmost importance, and continuous monitoring is essential to ensure successful regulation. Techno-vigilance serves as a vital system for identifying and evaluating adverse events related to medical devices.
Renewing a medical device manufacturing license in South Korea is critical for ensuring the safety and efficacy of medical devices in the market. The renewal process can be complex and time-consuming. This guide provides tips to any company seeking to renew their medical device license, including criteria for renewal, how to fill in a medical device license application, common mistakes to avoid, and the consequences of non-renewal.
The General Data Protection Regulation (GDPR) is a comprehensive privacy law enacted in the European Union in 2018. It applies to all organizations that process the personal data of individuals located in the EU, regardless of where the organization is located.
The Health Sciences Authority (HSA) is Singapore's Regulatory agency in the sphere of healthcare products. Importers and wholesalers dealing with medical devices in Singapore should develop a medical device Quality Management System (QMS) that conforms to the requirements of the Good Distribution Practice for Medical Devices (GDPMDS). SS 620: 2016 is the Singapore Standard for Good Distribution Practice for Medical Devices (SS620 GDPMDS).
When it comes to gaining Regulatory approval for medical devices, manufacturers must navigate a complex and time-consuming pathway. However, there is a powerful method at their disposal – the pre-Request for Designation (pre-RFD) submission. The pre-RFD submission allows manufacturers to seek early feedback from the United States Food and Drug Administration (US FDA) prior to embarking on the official Regulatory process.
In the dynamic business world, maintaining compliance, mitigating risks, and optimizing processes are critical for ensuring sustainable growth. As your organization navigates the complexities of the modern marketplace, a powerful tool that can bolster your efforts is an audit management system. In this blog, we shall explore what an audit management system entails, why it is essential for your business, and how it can lead you toward excellence and prosperity.