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Regulatory Files
- Medical devices EC mark
- In vitro diagnostic EC mark
- EC mark file update
- 510k file (USA)
- Heath Canada registration
Personalized Vigilance Bulletin
(annual subscription - quarter actualization)
- Regulatory Vigilance (Europe, USA, Canada,
international regulations)
- Normative vigilance (NF, EN, ISO, ASTM)
- Market
and technology vigilances (patents, 510k release, selection of website…)
- Scientific vigilance (selection of
international papers)
- Adverse side effects vigilance
If you want to receive a demonstration
specimen feel free to send an e-mail
idee-consulting@nordnet.fr (please precise your domain of interest)
Clinical data
- Literature review (French / English)
- Clinical data update
- Clinical Investigation plan
- Investigation
trial (results analysis & report)
Regulatory Assistance
- International regulatory expertise
- Device classification
- Validation protocol
- Biocompatibility assays
- Update
of Design Master File
Personalized training (theory & practice)
- Directive 93/42/EC
- NF EN ISO 13485 (2004)
- 21CFR part 820 – QSR – cGMP
- Quality audits
- Risk analysis ISO 14971
- Design control
- Software validation
Audits
- Conformity to Directive 93/42/EC
- Conformity
to NF EN ISO 13485
- Conformity
to NF EN ISO 14971
- Conformity
to 21CFR part 820 – QSR – cGMP
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