Case studies
Case studies
Selected engagements, described in the detail confidentiality allows.
European Class IIb imaging device manufacturer — recognition route
A CE-marked imaging system entered the Uzbek market via the recognition pathway.
Outcome- Class IIb
- recognition
- 7 months
Asian in-vitro diagnostics supplier — national pathway
An IVD product without a reference-regulator approval was registered through the full national route.
Outcome- IVD
- national
- 11 months
North American Class I device portfolio — multi-product filing
A portfolio of low-risk devices was registered in grouped filings under a single Authorized Representative.
Outcome- Class I
- recognition
- 5 months