Post Market Clinical Follow-up of medical devices is an important part of Post Market Surveillance. It is the process of monitoring devices in the real world environment.
Post Market Clinical Follow-up – Medical Devices Read More »
Post-market surveillance (PMS) is a pivotal aspect that governs the continued monitoring and assessment of medical devices after they have entered the market. Across the EU, UK, and USA, distinct regulatory frameworks shape PMS protocols, fostering safety, and innovation simultaneously.
Post Market Surveillance – Medical Devices Read More »
In today’s competitive marketplace, delivering high-quality products and services is essential for business success. A Quality Management System (QMS) is a structured framework that helps organizations ensure they meet customer requirements and enhance customer satisfaction. But what are the fundamental elements that constitute a robust QMS? In this blog, we will explore the basic components that form the backbone of effective quality management systems.
Understanding the core elements of Quality Management Systems Read More »
Medical device manufacturers face a daunting task: navigating complex regulatory landscapes to ensure their products meet safety and quality standards. In order to sell products in the US, manufacturers are required to comply with CFR 21 Part 820, whereas for global markets, the voluntary ISO 13485 is used. These two standards are not the same, and companies must understand the differences between them if they are to get their products to market across regions. However, with the FDA actively working to align CFR 21 Part 820 more closely with ISO 13485, the effort toward global harmonization is a promising sign for medical device manufacturers.
5 Differences Between ISO 13485 & FDAs Medical Device QSR Read More »
ISO 13485 is an international standard for mapping what is required from a medical device. The system ensures that medical devices are effective and consistent throughout their life cycle, from planning and production to disposal.
Ensuring consistency is extremely important for medical devices, as patient safety could be at risk. Implementing quality management systems can also provide protection for manufacturers and their reputations, as risks can be easily identified and rectified.
Medical device regulation varies based on the classification of the medical device being manufactured. All parties are required to demonstrate compliance, from the medical device manufacturing process to the disposal of the product.
What is ISO 13485? Read More »
EUDAMED stands for the European Database on Medical Devices. It is a secure, web-based platform established by the EU to collect, store, and disseminate information related to medical devices available in the European market. The primary objective of EUDAMED is to centralize and harmonize data on medical devices, manufacturers, and notified bodies throughout the EU member states.
EUDAMED: European Database on Medical Devices Read More »
Quality assurance (QA) and quality control (QC) are two important concepts in the medical device industry. Although they are related, there are distinct differences between the two. In this blog post, we will explore the difference between medical device quality assurance and quality control.
Quality Assurance & Quality Control Read More »
The ISO 13485 standard was built around the structure of ISO 9001 which is a standard for Quality Management Systems Requirements applied across all industry settings other than medical device companies.
ISO 13485 Standard – Quality Management System Read More »
Here we look at the top 3 medical device quality failures recorded in history. Do you agree with our list?
Top 3 Medical Device Quality Failures Read More »
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