In Vitro Diagnostic (IVD) devices play a crucial role in healthcare by providing valuable information for disease diagnosis, patient monitoring, and treatment decisions.
- August 28, 2023 Medical Devices, Regulatory Affairs
- August 28, 2023 Medical Devices, Regulatory Affairs
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.
- August 28, 2023 Medical Devices, Regulatory Affairs
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…
- August 28, 2023 Pharmaceuticals, Regulatory Artwork Services
In the fast-paced and highly regulated pharmaceutical industry, maintaining brand integrity is a fundamental building block of success. As pharmaceutical companies strive to deliver safe and reliable products, packaging artwork emerges as a crucial element in ensuring brand identity and compliance with Regulatory standards.
- August 28, 2023 Medical Devices, Regulatory Affairs
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.
- August 28, 2023 Pharmaceuticals, Regulatory Artwork Services
In the ever-evolving pharmaceutical landscape, artwork lifecycle coordination has emerged as a dynamic and innovative approach to mitigating risks and ensuring timely approvals. The intricate process of managing artwork throughout its lifecycle, encompassing design, revisions, artwork approvals, and Regulatory Compliance, requires fresh perspectives and proactive strategies.
- August 28, 2023 Medical Devices, Regulatory Affairs
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.
- August 25, 2023 Food and Food Supplements
What is Cultivated Meat?
Cultivated meat, also known as cell-based or lab-grown meat, is produced by growing animal muscle tissue from cells in a bioreactor rather than from traditional animal agriculture. It aims at replicating the taste, texture, and nutritional composition of conventional meat while eliminating the need for raising and slaughtering animals.
- August 25, 2023 Medical Devices, Regulatory Affairs
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.
- August 25, 2023 Medical Devices, Regulatory Affairs
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.