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Recent episodes
Südkorea MFDS Medizingerätegesetz 2026: Änderungen bei QMS und Lieferkettenüberwachung
Jul 20, 2026
5m 51s
SFDA Risikokommunikationsleitfaden (MDS-G-029): Was Hersteller in Saudi-Arabien wissen müssen
Jul 19, 2026
5m 33s
Health Canada Ministerial Reliance Order: Beschleunigte Zulassung für Medizinprodukte in Kanada
Jul 18, 2026
6m 07s
UK MHRA Medizinprodukteverordnung 2026: Was der Abschluss der WTO-Kommentarfrist bedeutet
Jul 17, 2026
5m 16s
EU REP Symbol-Übergang: Was Hersteller zur neuen EN ISO 15223-1 wissen müssen
Jul 16, 2026
5m 25s
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| Date | Episode | Topics | Guests | Brands | Places | Keywords | Sponsor | Length | |
|---|---|---|---|---|---|---|---|---|---|
| 7/20/26 | MedizingerätegesetzQualitätsmanagementsysteme+3 | — | Ministerium für Lebensmittel- und Arzneimittelsicherheit | Südkorea | MedizingerätegesetzSüdkorea+3 | — | 5m 51s | ||
| 7/19/26 | RisikokommunikationMedizinprodukte+3 | — | saudische Lebensmittel- und ArzneimittelbehördeMDS-G-029 | Saudi-Arabien | SFDARisikokommunikation+5 | — | 5m 33s | ||
| 7/18/26 | MedizinprodukteZulassung+3 | — | Health CanadaPure Global | — | Ministerial Reliance OrderHealth Canada+3 | — | 6m 07s | ||
| 7/17/26 | MedizinprodukteverordnungWTO-Kommentarfrist+4 | — | Medizinprodukteverordnung 2026International Reliance Pathway+3 | Vereinigtes KönigreichGroßbritannien | MHRAMedizinprodukte+6 | — | 5m 16s | ||
| 7/16/26 | EU REP SymbolMedizinprodukte+3 | — | Europäische KommissionEN ISO 15223-1:2021/A1:2025 | — | EU REPEC REP+5 | — | 5m 25s | ||
| 7/15/26 | MedizinprodukteRegulierung+3 | — | MedizinprodukteMDMA+3 | Saudi-Arabien | SFDAMDS-G-028+7 | — | 5m 53s | ||
| 7/14/26 | UDI-AnforderungenMedizinprodukte+4 | — | MedizinprodukteHochrisikogeräte+6 | Australien | UDITGA+5 | — | 5m 32s | ||
| 7/13/26 | EU-MDRetablierte Technologien+3 | — | KatheterKnochenfüllmaterialien+2 | — | EU-MDRWET+7 | — | 5m 03s | ||
| 7/12/26 | Regulatory GuidelinesNeurotechnology+3 | — | BCI-Technologiennicht-invasives EEG-Headset+3 | China | NMPABCI+5 | — | 6m 12s | ||
| 7/11/26 | Medical Device User Fee AmendmentsFDA regulations+4 | — | FDAPure Global+1 | — | MDUFA VIFDA+6 | — | 6m 13s | ||
| 6/12/26 | MedizinprodukteRegulierung+3 | — | nicht klassifizierte MedizinprodukteFDA | USA | FDA510(k)+5 | — | 5m 32s | ||
| 6/11/26 | EU KI-GesetzHochrisiko-Medizinprodukte+4 | — | Europäische UnionMDR+3 | EU | EU KI-GesetzHochrisiko-Medizinprodukte+6 | — | 5m 14s | ||
| 6/10/26 | MedizinprodukteFDA+3 | — | unklassifizierte MedizinprodukteFDA | — | FDAMedizinprodukte+5 | — | 5m 09s | ||
| 6/9/26 | MedizinprodukteNMPA+4 | — | NMPAPure Global | — | dynamisches AnpassungsverfahrenKlassifizierungskatalog+5 | — | 6m 05s | ||
| 6/8/26 | EU regulationsmedical device compliance+5 | — | MDRIVDR+2 | — | EU regulationMDR compliance+6 | — | 5m 53s | ||
| 6/7/26 | MedizinprodukteverordnungInternational Reliance+4 | — | Software als Medizinprodukteinmalige Produktkennung (UDI)+4 | Vereinigtes Königreich | MHRAMedizinprodukte+6 | — | 5m 33s | ||
| 6/6/26 | MedizinprodukteKennzeichnung+4 | — | MexikoNOM-137-SSA1-2025+2 | — | MedizinprodukteKennzeichnung+7 | — | 5m 06s | ||
| 6/5/26 | Human Factors EngineeringFDA guidelines+5 | — | FDAPure Global | — | FDAHuman Factors Engineering+7 | — | 4m 41s | ||
| 6/4/26 | MedizintechnikEUDAMED+3 | — | EUDAMEDPure Global | — | EUDAMEDMedizinprodukte+5 | — | 4m 57s | ||
| 4/10/26 | Medizintechnikstrukturelle Herzerkrankungen+3 | — | Edwards LifesciencesMedtronic+1 | 2026 | Medizintechnikstrukturelle Herzerkrankungen+5 | — | 3m 04s |
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