The design changes that happen early in the design process are less expensive when compared to those that take place after it is introduced into full-scale production. This guidance document elaborates upon the definition of "significant change" in the Regulations, in order to assist manufacturers in determining whether a change proposed to a class III or IV medical device requires the submission to Health Canada of a licence amendment application, prior to introducing the device to the market. As the diagram below illustrates, the design control cycle requires a phased approach to medical device design and development, gathering documentation together for review and approval at critical stages, while feeding into a master Design History File (DHF) that can be accessed at the end of the process. Implementation of a requirements tracking solution requires attention to a variety of nuanced topics. These products fall under the medical devices legislation and must be CE marked. Design Change Considerations Ombu Enterprises, LLC 28 The Basic Concept • The label of a medical device uniquely identifies the version or model of a device by the device identifier (DI) • The DI allows user access to a database (GUDID) that contains specific information and attributes about the device A medical device may contain an ancillary medicinal substance to support the proper functioning of the device. This planning will result in a time and money budget, which could be relevant for the decision whether to execute the change. The term Medical Devices, as defined in the Food and Drugs Act, covers a wide range of health or medical instruments used in the treatment, mitigation, diagnosis or prevention of a disease or abnormal physical condition.. Additional information on how medical devices are approved and authorized in Canada is available on the fact sheet "Safe Medical Devices in Canada". Jon Speer: Well, first of all, I felt like I should have done the intro for the global medical device part. Our popular EU MDR auditor training class is also an excellent deep dive into all facets of 2017/745. An improper design is not merely a flawed design in a medical device product lifecycle; instead, it means the product can be dangerous and hazardous to patients and, subsequently, the product can be rejected by the regulatory body due to its (flawed) design, damaging the image of the medical device supplier. The Medical Device Business Journal. In the past, changes to tech documents have bee implemented through the general change control system used for revisions to SOPs and etc. There is a design change request but only for changes to design including changes to various components in the devices. Figure: Waterfall Design Process. Lincoln and Associates . There is no single text that addresses the plethora of design issues a medical devices designer meets when developing new products or improving older ones; this book fills that need. For example, a component might have to be redesigned to facilitate the design change but redesigning this component might also necessitate the redesigning of other components. Speed to market is critical. Automating your design history file (DHF) and document management processes gives you an advantage. It can happen at any stage in the product development process. For Medical Device. When collected together in a V&V Report, the combination of verification and validation test results, along with traceability back to user needs, product requirements, and design specifications, provides part of the evidence the FDA requires when submitting a medical device for clearance. The application process of design controls is illustrated in the below figure. 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