Compliance & Regulations
Compliance & Regulations
Lengthen the life cycle of your connected device
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.
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End-to-end testing for a modern IoT device
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.
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Test first, test last – and in between
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?
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A smooth market entry with early phase testing
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.
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Only a small number of MedTech devices make it to the market – how to turn your invention into an actual health-promoting product
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.
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Quality assurance is a key factor in boosting a company’s competitive edge
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.
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Five missteps to avoid when starting to develop MedTech devices
A groundbreaking meter for biohackers? A handy gadget for surgeons? On the surface, the process of developing a MedTech device looks no different compared to other devices. However, due to heavy regulations and the high level of expertise required (specification, verification, and documentation) during the process, only a small number of MedTech products currently make it to the market. Setbacks can be avoided with better planning and assistance.
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What to do when your supply chain is out of components?
We are experiencing a major market disturbance that affects the supply of components and materials on a global scale. Currently, there exists more demand for components than supply on almost every sector. This has happened before in specific component categories but never on such a large scale. A unique situation in the history of global economy and electronics. There is an urgent shortage of almost every kind of electrical, metal and plastic component. The reasons for this are clear but what about the solution?
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MedTech devices and connectivity – Mission impossible?
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), and stricter cyber security requirements in health care.
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