Sample preparation in medical device design and testing serves as an investigative procedure to assess qualitative and quantitative measures and performances. Safety and quality are the preeminent factors in the medical device manufacturing industry. Stringent regulatory requirements are in place for every phase of a device’s life cycle, including design and testing. OEMs (Original Equipment Manufacturer) and companies that can design and then test medical devices or parts serve a vital role in the medical device industry. However, it’s imperative when looking for companies that can design and then test medical devices or parts demonstrate their quality management processes and practice in all facets of the product lifecycle.
All manufacturers of any class II and III medical devices, and a number of class I devices, must, by law, establish and maintain design control procedures for the device in order to ensure that specified design requirements are met. Manufacturers are required to establish and maintain such procedures to ensure those design requirements relating to a device are not only appropriate, but address the intended use of the device, that is, meeting the needs of user and patient each. The procedures must include mechanisms for resolving any issues that are incomplete, too ambiguous, or conflict with the regulatory requirements. The procedures must also allow for an adequate evaluation of conformance to the design and reference acceptance criteria essential for the proper functioning of the device. Design verification and validation procedures must also be met to ensure the device will perform as defined, and that the device conforms to user needs and its intended uses.
All medical devices should be tested in their final product form and condition before being introduced to the market. This is done not only to ensure the quality and safety of the product but to ensure the product’s success in a competitive the marketplace. This includes the evaluation and testing of parts or subcomponents of the device. To ensure safety, evaluation of medical devices must go beyond design by testing the constituent materials in manufacturing the device. Goals of testing should confirm the safety of individual device materials first, but then, in addition to that, confirm that the steps implemented in manufacturing the device did not compromise the biocompatibility of the device. Factors to consider are all the necessary agents and sterilizers that constitute the manufacturing process. There are a number of lubricants, additives, mold release agents, processing aids, cleaning agents and the like that may compromise the device or part upon contact with it. When looking for a company to manufacture your product be sure that the sample preparation design and testing protocols take these factors into account.
Sample preparation of your design should be evaluated in its final product form. In that way, the testing can be designed to incorporate everything involved in making the device. The materials must be safe for patients and the device must be biocompatible with the processes and materials used in the manufacturing process. In sample preparation for most devices, testing of materials should be prepared to mimic expected clinical conditions to determine the potential effects of chemical leachables. In sum, sample preparation for medical devices is one more important steps in the regulatory process to successfully bring your device to market. Device or part design and testing further establish functional parameters to ensure the product functions as designed and that the end result is the production of high-quality medical devices.
