The primary goal in the design and manufacture of a medical device is to produce a quality product that meets the applicable requirements and specifications for its intended use. Such a product provides assurance that the medical device can be consistently manufactured and will perform as planned, safely and effectively. This can be achieved through the implementation of a quality system.1
Medical device manufacturers who plan to take their product to the global marketplace should carefully review the ISO 13485 Medical Devices Quality management systems requirements for regulatory purposes and the US Code of Federal Regulations (CFR) Title 21, Part 820 Quality System Regulations(QSR).2,3 These requirements define the quality system standards for medical device design and manufacturing―good manufacturing practices for medical devices.
These quality system requirements (as per QSR) cover a wide range of topics1,2 such as:
Due to the broad variety of current and conceivable medical devices, the ISO 13485 standard and the US QSR do not stipulate how a manufacturer must produce a specific device. Rather, they ensure product quality by providing a framework that requires manufacturers to develop and follow written procedures specific to their medical devices.4 In other words, the manufacturer should establish methods and procedures to address the applicable quality system requirements related to the design, manufacture and distribution of their devices. Depending on the type of medical device or your organization, these requirements and standards may represent only a minimum baseline for designing and producing your medical device. Manufacturers may implement additional requirements or more sophisticated quality programs to meet the needs of their operations and the needs of their customers.
It is critical to understand that the ultimate responsibility for meeting these requirements resides with the manufacturer, even if some of the activities are delegated to a third party (for example, a contract manufacturing organization).4
The specific quality system requirements for Canada, the US and the EU are summarized in Table 1.
Table 1: Quality system requirements for Canada, the US and the EU
*Standards are updated periodically. It is important to ensure that the version followed is recognized by corresponding markets.
**A Notified Body is certification organization that the national authority of an EU Member State designates to carry out one or more of the conformity assessment procedures described in the annex(es) of the EU Directives. It must be qualified to perform all the functions set out in any annex for which it is designated.7
There are many way in which a manufacturer can provide greater assurance that their medical device is of the highest quality. These include:1
The information presented in these articles is intended to outline the general processes, principles and concepts of the healthcare product development lifecycle. Since regulatory requirements are ever-changing, it is current only as of the date of publication and not intended to provide detailed instructions for product development. Every healthcare product is unique and therefore so is its associated product development lifecycle. Specific advice should be sought from a qualified healthcare or other appropriate professional.
Published: October 17, 2012