Manufacturers of medical products, devices, components, and service providers today find themselves in a tough spot in the wake of complex regulatory requirements and changing customer needs. The challenge for them boils down to bringing new and improved products to the market as quickly as possible while adhering to the highest quality standards and all relevant global regulations. An essential aspect of this extensive process involves independent certification of products, processes, and quality management systems. These certification procedures can open markets, and the right choice of certification can make all the difference to stay ahead of the competition.
The device labeling needs to cover all aspects of the products in question, while quality packaging is necessary to ensure that the device is delivered to the consumer or healthcare center in an efficient and untampered state. The increasing scrutiny of the FDA on the Information For Use (IFU) leads to the need for each medical device to be labeled and packaged carefully. New consumer-based products to be introduced in the market need to pass a series of certifications and testing to ensure that they are safe to use, and will function appropriately through the product lifecycle.
The potentially life-saving medical devices tread the fine line between the appropriate utilization of the latest technology to ensure user benefit and careful evaluation of the same to prevent the misuse of personally identifiable information. The ever-increasing adoption of wireless technology in medical devices causes concern—regulators demand new and additional testing to keep up with changing device requirements. For example, the proliferation of the Internet of Medical Things (IoMT) has benefited patients and their families by enabling continuous health monitoring through wearable or insertable devices, but the technology comes with new regulatory compliance requirements. The right testing and certification service providers remain updated continuously about these changing requirements, making it a cakewalk for device manufacturers to meet regulations and introduce new and beneficial products to the market.
