par Administrateur | Août 3, 2023 | Regulatory
In our commitment to providing safe and efficient medical devices, we align with internationally recognized standards. One such standard is Directive 93/42/EEC (also known as MDD), a European Union directive that sets the framework for marketing medical devices. To...
par Administrateur | Août 2, 2023 | Regulatory
We understand the value of transparent and clear communication with our clients, especially when it comes to compliance with regulatory standards. For all our partners who distribute our medical devices, we want to provide assurance of our commitment to meeting the...
par Administrateur | Juin 20, 2023 | Regulatory
Understanding Medical Devices, their Classes, Market Dynamics, and a Deep Dive into the Production of Class IIa Nasal and Throat Sprays Medical devices form an integral part of the healthcare industry, spanning from simple tools like bandages to complex...
par Administrateur | Juin 20, 2023 | Regulatory
Implications of the Extended Transition Period and How it Impacts Legacy Devices and Their Marketing Authorization The evolution of the regulatory landscape in the medical devices sector has witnessed a notable transition from the Medical Devices Directive...
par Administrateur | Juin 19, 2023 | Regulatory
Exploring the Origins, Implications, and Future Impact of the MDR for Stakeholders in the Healthcare Sector The healthcare landscape is ever-evolving, with regulatory frameworks often adapting to ensure safety and efficacy of medical devices. One such...
