When it comes to selling medical devices in Europe, most people assume that CE marking is the manufacturer’s responsibility alone. While it’s true that the manufacturer plays the lead role, distributors are not off the hook.
CE Marking and Supply Chain Responsibilities Read More »
Expanding into the European Union (EU) or the United Kingdom (UK) is a big step for any medical device manufacturer. The markets are highly regulated — and for good reason. Patient safety, product quality, and regulatory compliance are at the core of the EU Medical Device Regulation (MDR), In Vitro Diagnostic Regulation (IVDR), and the UK Medical Device Regulations (UK MDR).
Authorised Representative / Importer for Your Medical Device Read More »
Under the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), compliance isn’t just the manufacturer’s responsibility. Importers, distributors, and suppliers are now considered economic operators — and that means you are legally liable for specific obligations. From verifying CE marking and language requirements to registering devices in EUDAMED and maintaining long-term traceability, your role in the supply chain is critical.
Understanding Your Obligations Under MDR/IVDR Read More »
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 »
Learn how post-market surveillance (PMS) helps medical device manufacturers monitor safety, collect real-world evidence, maintain MDR compliance and improve devices throughout their lifecycle.
Post-Market Surveillance (PMS) for 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 13485:2016 is the international standout standard that defines the precise requirements for a Quality Management System (QMS) specific to the medical device industry. Unlike general business quality frameworks, it prioritizes patient safety, clinical efficacy, and global regulatory compliance ahead of standard consumer satisfaction metrics.
Whether you are an active medical device manufacturer, a software-as-a-service (SaMD) developer, an importer, or an EU/UK distributor, demonstrating compliance with this standard is virtually mandatory to secure and retain critical market access.
What is ISO 13485? The Complete Guide to Medical Device QMS Read More »
EUDAMED (European Database on Medical Devices) is the European Commission’s central database for medical devices and in vitro diagnostic medical devices placed on the European market under the Medical Device Regulation (EU) 2017/745 (MDR) and In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR).
The database improves transparency, traceability, vigilance, and market surveillance throughout the device lifecycle. As EUDAMED becomes increasingly mandatory, manufacturers, authorised representatives, importers, and notified bodies must understand how the system works and what information must be submitted.
This guide explains the purpose of EUDAMED, its modules, implementation timelines, and key compliance obligations for economic operators.
What is EUDAMED? A Complete Guide for Medical Device Manufacturers Read More »
Thank you! The checklist is now ready to download.
