Compliance & Regulations

The requirements placed on MedTech products with connectivity are increasing. This is due to regulations such as the European Union’s Medical Device Regulation (MDR), the new Data Act, and stricter cyber security requirements in health care.

Does product testing keep you up at night? An expert in this field can help! Transforming an innovation, as an idea, into a tangible product or device is thrilling, but it involves a significant amount of work. Building the first prototype, launching production lines, developing the best go-to-market plan… and testing. The latter often gets overlooked, leading to many consequences. Ensuring proper testing is crucial, and that’s where a test manager’s assistance comes in handy. It can streamline the product’s market launch.

The security of your connected devices has never been more important. With the advancement of technology there is an increase in benefits and added value, and overall positive impacts. Because your device is connected it becomes more easily accessible to yourself, it also becomes more easily accessible to others. This means that hackers (malicious third parties, criminals) and other government agencies (military, critical infrastructure attacks) can also access your data more easily. That is why EU and USA are regulating the cyber security of devices, software and digital services.

There are many examples of devices having a shortened life cycle due to a power consumption issue, which leads to the battery of the device behaving unexpectedly. The frustration of users and claims of liability are a bad look and can cause damage to a company’s reputation. Fortunately, there is an answer for this problem many device manufacturers are facing: including automated power consumption measurements to your continuous integration of the software development cycle.

Etteplan’s internal research project for a centimeter-level navigation and positioning device offers a real-world example for planning your next IoT testing project. For IoT projects, we provide comprehensive HW, SW and compliance testing services – a one-stop-shop for all your testing needs.

Improve product quality with testing throughout the product development process. Especially end-to-end testing of embedded devices pays off. What should your future product be able to do? What should its features be like? What is required of it?

The earlier and more comprehensively a product is tested, the quicker it can be launched to the market. By planning testing and compliance, manufacturers can ensure rapid market access. Quick detection also maximizes operational capability. All this requires steps towards total quality control of product lifecycle.

There is an urgent demand for new MedTech devices that help meet the ageing population’s needs. Still, according to MedTech experts at Etteplan, it is estimated that only a handful of the MedTech ideas ever make it and become actual products.

Rising expectations of quality in the B2C context are changing the playing field for B2B customer expectations. The quality assurance service is a way to iron out the kinks in the process. Started early enough in the product’s life cycle, quality assurance plays an essential part in the product’s commercial success, cost-cutting, and making business sense.