What Are the Main Phases of Medical Device Development: Do you Understand the Requirements?
Do you have a Medical Device or In Vitro Diagnostic (IVD) that you are in the process of developing and would like to bring to the market? Are you feeling lost in the world of quality and regulatory, and unsure about what steps to take during the design and development stages? Well, you’re not alone…In this blog, […]
Top Medical Device Consultancy Companies – Consultant vs. Consultancy. What is Right for Your Business?
When you are looking to bring external regulatory or quality resources into your business, there is so much to consider. Will you feel more confident working with established consultancies, or are you looking to work with independent contractors? It is a challenge finding the right consultants who not only have the required expertise but also […]
Would You Know What to Do if Your Medical Device Company Went Bankrupt or Ceased Trading?
You may wonder what you would do if your company was in the unfortunate position of ceasing to trade or even bankruptcy, what it means for the business and whether it applies to your organisation. If your company aims to or already complies with the EU Medical Device Regulation (MDR) 2017/745 or EU In Vitro Diagnostic […]
Is my Software Application a Medical Device & if so, do I need to CE mark it?
This blog will show you the steps for categorising your software application & identifying the relevant regulations … The world of software is ‘fluid’ and ‘dynamic’, partly due to its virtual nature. Features can be added and removed, and this can impact the intended use and performance of software. As such, general use software (aka, […]
Medical Device Integration for Software: What Errors Really Cost You
In September 1999, NASA’s Mars Climate Orbiter missed its intended orbit and disintegrated due to atmospheric stresses. An investigation indicated that the Orbiter’s Device failure resulted from two pieces of software (one on earth and one on the orbiter) miscommunicating with different interface setups. One software was set to interpret data as imperial measurements (inches, […]
Benefits of Using ISO 13485 Quality Management System (QMS)
ISO 13485 is a quality management standard specifically designed for the medical device industry. It provides a set of requirements for a quality management system (QMS) that organisations can use to demonstrate their ability to design and manufacture medical devices that meet customer and regulatory requirements. Medical device manufacturers that want to distribute their products […]
