Compliance & Regulations

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.

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.

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?

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.

A Swedish MedTech company, NeoDynamics, is transforming the diagnosis and care of cancer with its newly-launched biopsy system, NeoNavia. For a company that started its journey as a small startup, a close collaboration with an experienced partner has paved the way for achieving significant milestones.

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