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Quality &
Regulatory
We define excellence as the intersection of quality and innovation. We are fully committed to providing innovative medical devices and services that meet industry standards and regulatory requirements through effective QC processes and safe work environments.
Quality Comes Standard with Every Product
Quality is our priority! We are making healthcare better by providing timely and accurate medical devices and services that meet regulatory requirements through an effective quality system and a safe work environment.
All medical devices manufactured by Argon Medical Devices, Inc. have been designed, developed and manufactured using standards specified by ISO 13485:2016 and the U.S. Food and Drug Administration.
All medical devices manufactured by Argon Medical Devices, Inc. have been designed, developed and manufactured using standards specified by ISO 13485:2016 and the U.S. Food and Drug Administration.
Certificates
If you have questions on regulatory documentation, global registrations, quality agreements, certifications or other compliance questions, please let us know.
For concerns about product performance, contact our Customer Feedback group.
Summary of Safety & Clinical Performance Documents (SSCP)
- Argon Guidewires
- SUMMARY OF SAFETY AND CLINICAL PERFORMANCE (SSCP)
- РЕЗЮМЕ ОТНОСНО БЕЗОПАСНОСТТА И КЛИНИЧНАТА ЕФЕКТИВНОСТ (SSCP)
- SOUHRN ÚDAJŮ O BEZPEČNOSTI A FUNKČNÍ ZPŮSOBILOSTI (SSCP)
- SAMMENFATNINGEN AF SIKKERHED OG KLINISK YDEEVNE (SSCP)
- ZUSAMMENFASSUNG DER SICHERHEIT UND KLINISCHEN LEISTUNG (SSCP)
- ΣΥΝΟΨΗ ΑΣΦΑΛΕΙΑΣ ΚΑΙ ΚΛΙΝΙΚΗΣ ΑΠΟΔΟΣΗΣ (SSCP)
- RESUMEN SOBRE SEGURIDAD Y FUNCIONAMIENTO CLÍNICO (SSCP)
- OHUTUSE JA KLIINILISE TOIMIVUSE KOKKUVÕTE (SSCP)
- TIIVISTELMÄ TURVALLISUUDESTA JA KLIINISESTÄ SUORITUSKYVYSTÄ (SSCP)
- RÉSUMÉ DES CARACTÉRISTIQUES DE SÉCURITÉ ET DES PERFORMANCES CLINIQUES (RCSPC)
- SAŽETAK SIGURNOSNIH I KLINIČKIH PERFORMANSI (SSCP)
- BIZTONSÁGOSSÁG ÉS KLINIKAI TELJESÍTMÉNY ÖSSZEFOGLALÁSA (SSCP)
- SINTESI RELATIVA ALLA SICUREZZA E ALLA PRESTAZIONE CLINICA (SSCP)
- SAUGOS IR KLINIKINIO VEIKSMINGUMO DUOMENŲ SANTRAUKA (angl. SSCP)
- DROŠUMA UN KLĪNISKĀS VEIKTSPĒJAS KOPSAVILKUMS (SSCP)
- SAMENVATTING VAN VEILIGHEIDS- EN KLINISCHE PRESTATIES (SSCP)
- PODSUMOWANIE ZAGADNIEŃ DOTYCZĄCYCH BEZPIECZEŃSWA I DZIAŁANIA KLINICZNEGO (SSCP)
- RESUMO DE SEGURANÇA E DO DESEMPENHO CLÍNICO (RSDC)
- REZUMATUL CARACTERISTICILOR DE SIGURANȚÜ ȘI PERFORMANȚĂ CLINICĂ (SSCP)
- SÚHRN PARAMETROV BEZPEČNOSTI A KLINICKÉHO VÝKONU (SSCP)
- POVZETEK VARNOSTI IN KLINIČNE UČINKOVITOSTI (SSCP)
- SAMMANFATTNING AV SÄKERHET OCH KLINISK PRESTANDA (SSCP)
- Worker Guidewires
- SUMMARY OF SAFETY AND CLINICAL PERFORMANCE (SSCP)
- РЕЗЮМЕ ОТНОСНО БЕЗОПАСНОСТТА И КЛИНИЧНАТА ЕФЕКТИВНОСТ (SSCP)
- SOUHRN ÚDAJŮ O BEZPEČNOSTI A FUNKČNÍ ZPŮSOBILOSTI (SSCP)
- SAMMENFATNINGEN AF SIKKERHED OG KLINISK YDEEVNE (SSCP)
- ZUSAMMENFASSUNG DER SICHERHEIT UND KLINISCHEN LEISTUNG (SSCP)
- ΣΥΝΟΨΗ ΑΣΦΑΛΕΙΑΣ ΚΑΙ ΚΛΙΝΙΚΗΣ ΑΠΟΔΟΣΗΣ (SSCP)
- RESUMEN SOBRE SEGURIDAD Y FUNCIONAMIENTO CLÍNICO (SSCP)
- OHUTUSE JA KLIINILISE TOIMIVUSE KOKKUVÕTE (SSCP)
- TIIVISTELMÄ TURVALLISUUDESTA JA KLIINISESTÄ SUORITUSKYVYSTÄ (SSCP)
- RÉSUMÉ DES CARACTÉRISTIQUES DE SÉCURITÉ ET DES PERFORMANCES CLINIQUES (RCSPC)
- SAŽETAK SIGURNOSNIH I KLINIČKIH PERFORMANSI (SSCP)
- BIZTONSÁGOSSÁG ÉS KLINIKAI TELJESÍTMÉNY ÖSSZEFOGLALÁSA (SSCP)
- SINTESI RELATIVA ALLA SICUREZZA E ALLA PRESTAZIONE CLINICA (SSCP)
- SAUGOS IR KLINIKINIO VEIKSMINGUMO DUOMENŲ SANTRAUKA (angl. SSCP)
- DROŠUMA UN KLĪNISKĀS VEIKTSPĒJAS KOPSAVILKUMS (SSCP)
- SAMENVATTING VAN VEILIGHEIDS- EN KLINISCHE PRESTATIES (SSCP)
- PODSUMOWANIE ZAGADNIEŃ DOTYCZĄCYCH BEZPIECZEŃSWA I DZIAŁANIA KLINICZNEGO (SSCP)
- RESUMO DE SEGURANÇA E DO DESEMPENHO CLÍNICO (RSDC)
- REZUMATUL CARACTERISTICILOR DE SIGURANȚÜ ȘI PERFORMANȚĂ CLINICĂ (SSCP)
- SÚHRN PARAMETROV BEZPEČNOSTI A KLINICKÉHO VÝKONU (SSCP)
- POVZETEK VARNOSTI IN KLINIČNE UČINKOVITOSTI (SSCP)
- SAMMANFATTNING AV SÄKERHET OCH KLINISK PRESTANDA (SSCP)
We Define
Excellence
Excellence