RegDesk News/Info Sometimes, managing medical device submissions can feel like dating in high school- lots of rejection. In an industry where regulatory compliance comes with the highest stakes, it’s surprising that failure to comply with submission requirements is so...
North America Previously in 2014, the FDA has published a final guidance discussing premarket expectations but the constant technology advancements and changes requires a new guidance. As a result, on October 18, 2018, the FDA published a draft guidance about cybersecurity and it...
EU MDR/IVDR European trade association, MedTech Europe, published a detailed plan. It aims to help the member states speed up and simplify the process of implementation of new MDR/IVDR regulations. The plan intends to assist states and national medical regulating authorities by...
North America Mobile phones have become such an influential factor of our daily lives that it is almost a necessity for us. It provides efficient solutions to many tasks such as banking, shopping, and much more. With its such prevalent use, manufacturers are seeking ways to use...
EU MDR/IVDR European Commission informed that as a result of implementation of medical device and in vitro diagnostic regulations, there could be an issue of availability of several types of devices. The root of the problem is due to some manufactureres deciding to suspend the...
