This article explores the significance of clinical investigations in assessing the safety and effectiveness of software as medical devices (SaMD) and how they contribute to advancing patient care and medical innovation.
How much does a clinical trial cost? Getting the budget right for a clinical investigation is both important and challenging. A well-prepared budget can help convince stakeholders, such as managers, sponsors, or potential investors, of the project’s feasibility. This
This article covers the responsibilities of the sponsor – one of the most important stakeholders in a clinical investigation. Some of the main responsibilities include The main sponsor responsibilities are: clinical quality management, communication with regulatory authorities, clinical investigation planning and conduct, and outsourcing duties and functions.
GCP is an international quality standard that governments can transpose into regulations that decide how clinical trials involving human subjects must be managed. Understanding the GCP principles allows for a successful setup and management of clinical studies and collecting data that can stand up to regulatory scrutiny.
The ISO 14155 standard has undergone some changes in its 2020 edition, mainly in order to ensure that the standard continues to keep its global acceptance by regulatory authorities. This article will present the main changes compared to the previous version of the standard.
Clinical research is necessary to develop new treatments for different diseases and conditions that occur in humans. To develop these new treatments, clinical trials have to be performed to get proof that the new treatment works and that it is safe.
Take a look at our online Risk Management course on ISO 14971:2019 and online Design Control for Medical Devices course.
These courses are taken by both competent authorities, notified bodies and medical device manufacturers and distributors.
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