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When a medical device is ready to be sold in Europe, manufacturers must acquire a CE Mark, which represents the minimum safety and quality standards set forth by the European Union. Additionally, before a product can obtain its CE Mark, the manufacturer will need to complete a clinical evaluation using a number of clinical trials to assess performance and safety of the device. Ultimately, the question of how many patients you should include in your clinical trial, for your device to achieve CE Mark, is an important one; however, there is no "one-size-fits-all" answer as how large of a patient population will be required varies by medical device type and use, as well as medical device classification, risk classification and clinical evaluation strategy. In this guide, we provide an overview of how regulators determine sample size requirements along with how other factors, such as device classification, regulatory requirements and clinical evaluation plan, will factor into how ...

As industries are changing faster than ever before, companies around the world are focusing efforts on making sure their workplaces are safe for all employees. Companies are expected not only to be compliant with regulations but also to take proactive steps to protect their employees from injury or illness while simultaneously minimizing their environmental footprint. One of the most widely accepted international management system standards that help companies achieve this balance is the ISO 45001:2018 Occupational Health & Safety Management System. The ISO 45001:2018 standard offers an organized approach to the management of the risk and opportunity of occupational health and safety for businesses. By acquiring an ISO 45001:2018 Certificate, a business is demonstrating its commitment to providing a safe and healthy environment for employees, and improving the physical and emotional welfare of workers as well as promoting sustainable business practices. This article discusses some ...