The special focus is in patient safety in the design of medical devices
Medical devices and software are more laboriously placed on the market than normal consumer products. Many aspects of risk management, design process, usability and quality of production must be taken into account. While bureaucracy may seem awkward, things are in the light of the current regulation quite sensible as long as you know what to do and in what order.
In medical and in-vitro equipment design and marketing, the special focus is in patient safety. This introduces special requirements for product life cycle management from design to production and monitoring of use. The authorities monitor that the development work has been done in a way thatensures the safety and the quality of the product.
Regulations guide the design
The design and management of medical devices in the European Union is governed by regulation MDR 2017/745. The regulation of medical in vitro equipment is IVDR 2017/746. These set the requirements to the manufacturer for the design, placing on the market and monitoring of the device or software. (In this case, the manufacturer means the product owner or representative responsible for the product, its quality and monitoring).
For medical devices and software, separate approvals are required for each market area where the product is to be sold. Basics are all very similar but the required documentation, as well as standards, and especially their versions, may have significant differences. There are several key areas for approval, each of which must also have documentation. Approval is always sought by the manufacturer of the product (ie the company that sells product to the end customers and is responsible for it).
With careful design you will ensure that your product is accessed on the market
There are many regulations and standards in medical device and software development. Ignoring them can be costly and time-consuming for the company. If you are not careful in the initial phase you may have difficulties coming forward later. Consequences may be fatal to the product and it may be impossible to get the product to the market. The money is spent when the product development steps are repeated.
We have made a quick guide that tells the most important issues that should be taken into account in the product development of a medical device or software. You can download the guide HERE.
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