From new regulation transition to gap assessment and remediation activities

PLG can support all leading economic operators (manufacturers, distributors, authorized representatives, etc.), ensuring patient safety and regulatory compliance throughout the medical device lifecycle. From a product’s initial development design stage to ongoing post-market surveillance, we will assist you in managing the transition to the new MDR and IVDR regulations. Our services span from gap assessments to remediation, including quality management system (QMS) technical and software documentation according to regulatory requirements, referring to the harmonized standard list (ref. to applicable IEC and ISO standards). We possess in-depth knowledge of evolving regulations supporting you in updating MDR/IVDR compliant files across various device categories. 

Strong expertise and meticulous industry knowledge

– Our experts have successfully managed multiple projects, collaborating with different notified bodies and ensuring the transition from MDD to MDR and from IVDD to IVDR. 

– Thanks to our coordination efforts, we offer a comprehensive remediation plan, a complete overview of remediation, and related supporting activities to ensure compliance. 

– We have in-depth knowledge of IEC and ISO standards such as IEC 62304/IEC 82304 for software, ISO 13485 for quality systems, ISO 10993-1 for biocompatibility, IEC 62366 for usability,  and ISO 14155 for clinical investigations. 

KEY FIGURES

60+

Migrated devices from MDD to MDR