Step-by-Step Process: How to Conduct a Performance Evaluation for your In Vitro Diagnostic Device
What is Performance Evaluation and Why is it Important? Under the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR), all In Vitro Diagnostic (IVD) devices must undergo a Performance Evaluation before they are placed on the market. This process is a continuous one, conducted throughout the device’s lifecycle, ensuring that it remains safe, accurate, […]
Understanding Regulatory Intelligence in the Medical Device Industry
The Growing Importance of Regulatory Intelligence With regulatory requirements continuously evolving and the increasing stringency of medical device legislation, it’s no surprise that regulatory compliance can feel overwhelming, especially for manufacturers managing multiple markets. While Regulatory Intelligence (RI) may appear simple for low-risk devices such as Class I non-sterile products, the process becomes significantly more […]
ISO 13485 Quality Management System Implementation: A Guide to Creating a Quality Manual
ISO 13485 is an international standard that outlines the requirements for a quality management system (QMS) for organisations involved in the design, development, production, installation, servicing, sales, and distribution of medical devices (including in vitro diagnostics). Clause 4.2.2 of the standard requires the organisation to document a quality manual. What is a Quality Manual? A […]
The Most Common Problems in Creating Technical Documentation for your Medical Device
Navigating the intricacies of EU/UK medical device regulations in preparation for the creation of technical documentation that is necessary for market entry, can prove challenging; and it can also be incredibly difficult to understand the requirements to streamline the reviewal process. As if the requirements aren’t complex enough, we need to be prepared for the increased scrutiny […]
Main Phases of Medical Device Development: Key Requirements for Compliance & Market Success
Developing a medical device or an In Vitro Diagnostic (IVD) and bringing it to market can be a complex process filled with regulatory hurdles and quality management challenges. Understanding the main phases of medical device development and the regulatory requirements can streamline your efforts and ensure that your device meets all necessary standards for market […]
Top Medical Device Consultancy Companies – Consultant vs. Consultancy. What’s Right for Your Business?
When navigating the complexities of medical device development, one of the most critical decisions you’ll face is whether to hire an independent consultant or to engage with a consultancy firm. Both options come with their own sets of advantages and challenges, but what’s the right choice for your business? As a medical device consultancy company, […]