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Compliance & Regulations

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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Compliance & Regulations

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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Compliance & Regulations

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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Compliance & Regulations

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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Compliance & Regulations

Revolutionizing the diagnosis and care of cancer – Case NeoDynamics

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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Compliance & Regulations

Using Fault Tree Analysis to analyse software architecture in automotive design

Fault Tree Analysis can help keep your vehicle working, whether it is on Mars or in your neighbourhood.

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Compliance & Regulations

Standardization of production test systems – 3 benefits to production testing ownership

Manufacturing costs are under continuous pressure. One can claim, that manufacturing costs have risen year after year. The increase in cost is due to many things such as the price of component costs, labor costs and quality costs. Quality is affected by many factors one of them being production testing. However, testing does not have to be a mandatory evil but can be translated into efficiency and benefits for the company. Many companies have seen that the similarity in test equipment and test methods on production lines can improve overall efficiency. Standardization of testing is one essential part of achieving efficiency. Standardization requires ownership of testing and continuous work which then minimizes the total cost of ownership.

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Compliance & Regulations

Towards less vulnerable embedded electronics – New regulation for cybersecurity

Electronics manufacturers will soon be under new regulation that demands cybersecurity from their products, and even from their development process. Why is this happening, where does it apply, and what must be done?

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Compliance & Regulations

3 tips towards developing cybersecure products

New regulations will soon set cybersecurity requirements to almost all electronical products. For manufacturers this will mean that security should be integrated into the product development process. What does it take to ensure that end products are going to fulfill the rules?

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