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.
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.
Literature reviews play a crucial role in the clinical evaluation of medical devices and In Vitro Diagnostics (IVDs) throughout their entire lifecycle. These reviews enable researchers to examine previous studies, build upon existing knowledge, and contribute meaningfully to their respective fields. However, adhering to traditional approaches in a literature review can be time-consuming and arduous, particularly considering the evolving needs and demands of the medical field. This can lead to missed opportunities and incomplete analysis.
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 today's world, businesses in regulated industries like healthcare and life sciences need to follow compliance with industry-specific regulations. Regulatory documents serve as vital communication tools with governing authorities, demonstrating adherence to guidelines, ensuring public safety, and supporting critical business decisions. However, managing these documents efficiently and accurately can be an overwhelming task. Regulatory Document Management Software (RDMS) offers numerous benefits that can significantly improve an organization's Regulatory document processes.