Gap Assessment

Every year brings new requirements and changes or additions to existing requirements to the world of MedTech and Pharma, making it challenging to keep up with and interpret the consequences. A recent example could be the  MDR / IVDR Transition. Our regulatory affairs department can help your organization get on top of current regulatory requirements through gap assessment. We help make sense of the regulatory lingo and turn it into meaningful and actionable insights The RA specialists at Technolution are also experienced helping organizations quickly respond to unexpected regulatory changes. We’ll help craft the necessary responses to regulatory bodies while keeping your development project on track.