510k submission CB Scheme ce check ce marking ce marking documentation ce marking process clever compliance compliance compliance management system compliance metrics compliance officers declaration of conformity electrical equipment electromagnetic compatibility issues emc directive en standards eu authorised representative expert consultation FCC FDA FDA certification GAP analysis iec standards iso standards IVDR market surveillance regulation MDR MDR requirements medical devices ppe 2016/425 product certification product certification mark product compliance hub product compliance management product design phase product markings product safety quality control Risk classification risk management rohs compliance scip scip notification scip requirements standards supplier compliance management technical file time management useful tools