The European Union (EU) Network and Information Security Directive 2022/2555 (NIS2) went into effect on January 16, 2023, triggering a 21-month countdown for Member States to transpose the measures into national law. Although NIS2 is an enhancement to its predecessor NIS1, the overall objective remains consistent: improve cybersecurity across the…
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As the landscape of the medical devices industry continues to evolve, it is increasingly essential to be able to recognize and understand the nuances of regulatory standards and management systems going forward. Both the European Union Medical Device Regulation (EU MDR) and ISO 13485 play crucial roles in ensuring the…
As Artificial Intelligence (AI) is transforming many sectors and it is impacting the way people live, work, and interact, its influence in society is only growing stronger. However, this rapid widespread and development of AI raises many concerns including various aspects such as bias, privacy protection, and other potential risks.…