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...
, MDR/MDD and other applicable global regulatory requirements and standards. Apply balance of risk, regulatory intent... of experience in design quality. Expert knowledge and experience in applying MDSAP, FDA, MDD/MDR and ISO Quality standards...
Council Directive: 93/42/EEC Medical Devices Directive (MDD) EU Regulation: 2017/745 Medical Devices Regulation (MDR) MDSAP...
(including QSR, ISO, OSHA, IVDD, MDD) are met and the inspection schedule is satisfactorily attained. Analyzes work processes... - Strong leadership and organizational skills - Knowledge of current QSR, ISO, OSHA, IVDD, MDD regulations desirable...
and 804 (MDR regulations), ISO 13485, ISO 14971, and MDD 93/42/EE. 4. Ability to execute established procedures and protocols... such as FDA QSR, ISO 13485, and the MDD required. Experience in a start-up environment preferred. Experience with catheter-based...
with appropriate strategies that supports the OPDC objectives and aligns with the business and OPCJ/OPDC/MDD development programs...: Support and implement appropriate filing strategies working with OPCJ, OPDC, MDD and OAPI departments to support registration...
, EU MDD/MDR and/or Canada including writing, compilation, submission, interaction with health authority(s), and continuing...
, and/or efficiencies. Requires background and familiarity with U.S. FDA QSR, requirements including ISO 9001, MDD 93/42, and ISO 13485...
, and/or efficiencies. Requires background and familiarity with U.S. FDA QSR, requirements including ISO 9001, MDD 93/42, and ISO 13485...