Benefits & Importance Of Having Design Control System In The Field Of Medical Device

According to the statistics, it is reported that a significant percentage of all the medical device recalls are occurred due to design problems. A medical device recall can result in lost revenue for the manufacturer, unplanned development costs and can also significantly affect the end user or consumer. As an organisation owner in the field of medical device, you need to know that the safety, quality and effectiveness of a device are known to be established during the design phase itself. Established in 1996, design control has been a quality system requirement for many medical device organisations who are struggling to understand these requirements as well as for those who don’t have knowledge about when to start the process and how to maximize the benefits of the system.

Most of the medical device manufacturers were often mistaken that a design control must be a complex process to meet the regulatory requirement standards and to ensure delivery of high quality and safe product that meets customer demands and standards. Additionally, another common mistake made by most of the medical device manufacturers is initiating the Design control system process later in the overall and complete design process of the product. Understanding the elements of the design control system will not only help your organisation focus on the important aspects of the product that you have designed or invented, but it also helps in reducing the risk to the patient and getting the device to the market efficiently and more faster.

What Is the Design Control System?

The design control system is defined as an integrated set of management practices which includes the policies, processes and procedures that are applied to control design activities while correcting errors and accessing quality through an initial process or development of a product. Having an efficient design control system for your organisation means, as the device manufacturer you will be benefited from a successful return on investment and also the end user benefits from an effective and safe product. Orcanos is the reputable and one of the leading providers of the best design control system that are made up of several elements with documented procedures to all types of Enterprises.

Orcanos is the one-stop solution for all your compliance management needs and you can streamline your design control, quality management system and regulatory compliance in a single integrated system. Orcanos provides an integrated application lifecycle management ALM or Design control for requirements management, Test Management, Defect Tracking, FMEA Risk Management. And the design Input and design output of requirements management help in simplifying tracking of your requirements and they are flexible enough to serve SMBs and powerful for Enterprises. For more details and other information to know about Orcanos please visit our website here:


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Orcanos provides an cloud ALM system that combines quality (QMS) and regulations into the R&D process, thus assuring better FDA, ISO, CE compliance.

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