Compliance & Regulations

Technical documentation is essential for product success, as it connects the product to all stakeholders. However, creating effective documentation that meets user needs is challenging. It requires following regulations, avoiding too much or irrelevant information, and understanding the purpose of the documentation. The key is striking the right balance to provide clear, useful information to users.

In today’s rapidly evolving digital landscape, cybersecurity is a critical aspect of product development. Ensuring that products are secure and protected from anticipated threats is paramount to the success and reputation of any organization. That’s where SPDL (Secure Product Development Lifecycle) comes into play. SPDL is a comprehensive framework that provides guidance and structure for developing and maintaining secure products. According to the widely adopted IEC 62443-4-1 standard, it consists of eight essential practices that cover every stage of the product lifecycle.

PSK Standardisointi has published the world’s first basic occupational safety training standard targeted at industrial environments. While many occupational safety standards provide guidance on, among other things, occupational safety management systems (e.g., ISO 45001), the new PSK 6803 -standard focuses specifically on the content and organization of basic occupational safety training.

The world of cybersecurity is constantly evolving, with regulations rapidly adapting to keep up with emerging threats and technological advancements. As sophisticated and approachable experts in the field, we understand the importance of legal compliance in safeguarding businesses and individuals from cyber risks. In this article, we will provide valuable insights on implementing compliance to new cybersecurity regulations affecting products and entities, empowering you to navigate the regulatory landscape effectively.

The combination of machine vision and machine learning offers great opportunities for healthcare. Utilizing data-driven technology requires new skills and understanding of data.

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.

Czy testowanie produktu spędza Ci sen z powiek? Ekspert w tej dziedzinie może Ci pomóc! Przekształcenie innowacji, jako pomysłu, w rzeczywisty produkt lub urządzenie jest ekscytujące, ale wiąże się również z dużą ilością pracy. Budowanie pierwszego prototypu, uruchamianie linii produkcyjnych, opracowanie najlepszego planu wprowadzenia na rynek… i testowanie. Ten ostatni często jest zapominany, co niesie ze sobą wiele konsekwencji. Aby zadbać o przeprowadzenie odpowiednich testów, warto skorzystać z pomocy mengera testów. To pomoże skrócić drogę wdrożenia produktu na rynek.

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.