Tag: Software medical device EU


Meeting Medical Software Regulatory Requirements

The development of a sound regulatory strategy is an essential starting point for medical device and in-vitro diagnostics (IVD) manufacturers. Regulatory strategy planning is critical to ensure compliance with all legislation and standards, particularly because the regulatory environment can vary from country to country. When developing a strategy, there are several factors that must be considered including customer needs and the nature of a particular target market. What changes software into a medical device? The definition of a medical ‘device’ also tends to vary by country so a good starting point is......

Continue Reading