Training

Medical Devices

Framework of modern medical software development lifecycle

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Medical Devices

GDPR for Medical Devices

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Standardi

ISO 13485 -standardi tutuksi

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Standardi

ISO 13485 -standardin mukainen sisäinen auditointi

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Standardi

ISO 14001 -standardi tutuksi

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Standardi

ISO 14001 -standardin mukainen sisäinen auditointi

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Standardi

ISO 14971:2019 Riskienhallinta

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Standardi

ISO 22870 standardi tutuksi

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Standardi

ISO 9001 –standardin sisäisen auditoinnin syventävä koulutus

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Standardi

ISO 9001 -standardin mukainen sisäinen auditointi

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Standardi

ISO 9001 -standardi tutuksi

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Medical Devices

Product safety: Electrical, mechanical, radiation, usability, software

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Medical Devices

Product safety: Electromagnetic Compatibility of electrically operated products

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Medical Devices

Perusteet lääkinnällisten ohjelmistojen kehittämiselle

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Medical Devices

Regulatory Essentials in Health Tech - Full Training Series

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Regulatory Essentials

Regulatory Essentials in Health Tech: Compliance as a Business Advantage

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Regulatory Essentials

Regulatory Essentials in Health Tech: Early Development and Management

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Regulatory Essentials

Regulatory Essentials in Health Tech: The Core of the Regulatory Requirements

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Regulatory Essentials

Regulatory Essentials in Health Tech: Design Control and the Regulatory Environment

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Regulatory Essentials

Regulatory Essentials in Health Tech: Regulatory Essentials of In Vitro Diagnostics

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Regulatory Essentials

Regulatory Essentials in Health Tech: Medical Device Software

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Regulatory Essentials

Regulatory Essentials in Health Tech: Risk Management in Practice

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Regulatory Essentials

Regulatory Essentials in Health Tech: FDA

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Regulatory Essentials

Regulatory Essentials in Health Tech: Usability and Labelling

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Regulatory Essentials

Regulatory Essentials in Health Tech: Biological and Electrical Safety

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Regulatory Essentials

Regulatory Essentials in Health Tech: Clinical Evaluation in Practice

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Regulatory Essentials

Regulatory Essentials in Health Tech: Clinical Investigations in Practice

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Regulatory Essentials

Regulatory Essentials in Health Tech: Post-Market Surveillance and Clinical Follow-up

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Regulatory Essentials

Regulatory Essentials in Health Tech: Person Responsible for Regulatory Compliance

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Standardi

SFS-EN 15224 -standardi tutuksi

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Standardi

SFS-EN 15224 -standardin mukainen sisäinen auditointi

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Standardi

Uudistettu SHQS (Social and Health Quality Standard) -standardi 2.0 tutuksi

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Standardi

SHQS:n mukainen sisäisten auditoijien täydennyskoulutus

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Medical Devices

Online training on the basics of the IVDR (EU) 2017/746 requirements

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Standardi

SHQS:n mukainen sisäisten auditoijien koulutus

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Standardi

Säteilynkäytön sisäinen kliininen auditointi -koulutus

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Standardi

ISO 15189 -standardin mukainen sisäinen auditointi

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Standardi

ISO 15189:2022 -standardi tutuksi

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Standardi

ISO/TS 20658 standardi tutuksi

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Laboratorio

EKG ja Holter -tutkimukset

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Laboratorio

Ulostenäytteenotto

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Laboratorio

Histologisten näytteiden ottaminen ja käsittely

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Laboratorio

Laskimonäytteenotto

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Laboratorio

Lasten näytteenotto

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Laboratorio

Mikrobiologiset näytteet

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Laboratorio

Spirometria ja bronkodilataatio sekä diffuusiokapasiteetin mittaus

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Laboratorio

Virtsanäytteenotto

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Laboratorio

Laiteverifiointi ja -validointi– Mitä tulee ottaa huomioon?

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Laboratorio

Näkökulmia laiteverifiointeihin – asiantuntijan työkalupakki

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Laboratorio

Kvantitatiivisen laitteen verifiointi

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Laboratorio

Laiteverifiointien tilastomatematiikka

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Laboratorio

Mikrobiologisen laitteen verifiointi

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Laboratorio

Mittausepävarmuuden huomioiminen laiteverifioinnissa

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Vieritestaus

Vieritestauksen sisäinen ja ulkoinen laadunarviointi

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Medical Devices

Clinical evaluation of medical devices according to MDR & MEDDEV 2.7/1 Rev. 4

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Medical Devices

Clinical Research under MDR and ISO 14155:2020

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Medical Devices

PMCF in accordance with MDR and MDCG

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Medical Devices

Publication of clinical study data

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Laboratorio

Verenkuvatulosten tulkinta – mitä analysoijan tulee tietää?

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Vieritestaus

Vieritutkimuspassi: COVID-19

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Vieritestaus

Vieritutkimuspassi: CRP

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Vieritestaus

Vieritutkimuspassi: Glukoosi

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Vieritestaus

Vieritutkimuspassi: INR

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Vieritestaus

Vieritutkimuspassi: Spiro

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Vieritestaus

Vieritutkimuspassi: EKG

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Vieritestaus

Vieritutkimuspassi: HbA1c

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Vieritestaus

Vieritutkimuspassi: Strep A

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Vieritestaus

Vieritutkimuspassi: Virtsan liuskakokeet

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Laboratorio

EKG-löydösten tunnistaminen

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Laboratorio

Gynekologinen näytteenotto

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Clinical Investigations

ICH GCP E6 (R2)

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Medical Devices

Klinische Bewertung von Medizinprodukten (gemäß MDR & MEDDEV 2.7/1 Rev. 4)

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Clinical Investigations

Curricular training for investigators and members of clinical investigation teams/groups

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Clinical Investigations

Curriculare Fortbildungen für Prüfer und Mitglieder eines Prüfungsteams/einer Prüfergruppe

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Medical Devices

Klinische Forschung unter der MDR und ISO 14155

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Medical Devices

PMCF gemäß MDR und MDCG

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Medical Devices

Publikation von Studiendaten

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Standardi

Poikkeamat muutosvoimaksi

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Lääkinnälliset laitteet

Lääkinnällisten laitteiden kliininen arviointi ja kliiniset laitetutkimukset

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Medical Devices

Health Tech Regulations, Quality Management and Commercialization

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Tehokas muutoksen hallinta

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Vaikuttavan laatukulttuurin rakentaminen

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Lääkinnälliset laitteet

PRRC Connection

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Clinical Investigations

Clinical Investigations 101

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Standardi

ISO 9001 täydentäminen ISO 14001 standardilla

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