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, […]
What to Do if Your Medical Device Company Goes Bankrupt or Ceases Trading
In the unfortunate event that your medical device company ceases to trade or faces bankruptcy, it’s crucial to understand the implications, especially in terms of compliance with the EU Medical Device Regulation (MDR) 2017/745 and the EU In Vitro Diagnostic Regulation (IVDR) 2017/746. These regulations stipulate specific administrative requirements that businesses must adhere to, even […]
Is my Software Application a Medical Device & Do I Need to CE Mark It?
This blog will guide you through the steps for categorising your software application and identifying the relevant regulations under the EU Medical Device Regulation (MDR) 2017/745 and In Vitro Diagnostic Regulation (IVDR) 2017/746. Understanding Software as a Medical Device (SaMD) Software is inherently dynamic and flexible. Its features and functions can evolve rapidly, sometimes shifting […]