In the rapidly evolving world of MedTech, staying compliant with the latest regulations is more critical than ever. The updated Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) have introduced more detailed and stringent requirements, pushing many product classifications into higher-risk categories. Consequently, MedTech companies may find themselves in need of specialised knowledge […]
The medical device industry is undergoing significant regulatory changes with the transition from the Medical Device Directive (MDD) to the Medical Device Regulation (MDR). These new regulations aim to enhance the safety, performance, and traceability of medical devices within the European Union. In this blog post, we will compare MDD and MDR, highlight the key […]
In the dynamic and highly regulated world of pharmaceuticals, ensuring GxP (Good Practice) compliance is essential for maintaining the highest standards of product quality, safety, and efficacy. GxP compliance encompasses a comprehensive range of regulatory requirements that govern every aspect of pharmaceutical production and distribution. Join us as we explore the importance of GxP compliance […]