of regulations and standards Such as MDD, MDSAP, MDR, NMPA and applicable US Code of Federal Regulations CFR 803, 806 and 820, ISO...
regulations), Canadian Medical Device Regulations, ISO 14971, ISO 13485, and MDD 93/42/EEC Ability to analyze and interpret...
regulations), Canadian Medical Device Regulations, ISO 14971, ISO 13485, and MDD 93/42/EEC Ability to analyze and interpret...
through regular communication, between company, investigators and experts in conjunction with Medical Dev. Director (MDD...
industries) Working knowledge of ISO 13485, ISO 14971, 21 CFR 820, IEC 62304, IEC 60601-1 and MDD/EU MDR. Ability to author...
and registrations (e.g., ISO, FDA, IVDD/IVDR, MDD/MDR), as well as product safety and regulatory compliance. Overseeing the regulatory...
, ensuring conformance to specifications and compliance with all regulatory requirements, including FDA, MDD, UL, CSA...
Requirement Document BRD Functional Requirement Document FRD Minor Development Document MDD Jira Epics etc. · Facilitate project...
Requirement Document BRD Functional Requirement Document FRD Minor Development Document MDD Jira Epics etc. · Facilitate project...
ISO 10993 Experience working with global regulations and requirements, especially the EU Medical Device Directives (MDD...