Heron Medical Device Compliance Support
medical devices
About
Created to consult, advise, assist, review, revise and input registration strategy in the medical device field from individual projects to global processes Areas include: -Notified Body expectations under MDR-MDCG and also FDA, MDSAP & NMPA guidelines -Innovation and clinical compliance -Registration of new products class 1 to III -Harmonising QMS-RA-CA for greater success -Platforms for data analysis & data management -Clinical compliance pre-registration & post-registration -Post Market Surveillance: PMS & PMCF requirements -Real World Evidence & other registries -SSCP & what is important to know -EUDAMED & patient understanding & consequences
Keywords
project management
peer review publication expertise
big picture analysis
notified body audit preparation
nmpa
rwe
mdr
critical review of tech files
single document review critique
medical devices
strategy for registration
mdcg guidances
qms regulatory clinical interactions
pmcf
mdsap
positive approach seeking success in a calm environment
innovation clinical strategy
marketing material compliance
qms mdr ra ca
fda
clinical compliance
classes i ii iii
medical equipment manufacturing
productivity
hospital & health care
Company Information
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Employees 3
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Founded 2022
Location
La Rochelle, Aquitaine-Limousin-Poitou-Charentes, France
