Integrated diabetes healthcare Frank Westermann CEO mySugr GmbH

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Presentation transcript:

Integrated diabetes healthcare Frank Westermann CEO mySugr GmbH

Founded ,000 users 20 Employees (8 with Type1 Diabetes) Offices in Vienna & San Francisco CE marked & FDA registered TÜV certified processes (ISO 13485) Company

mySugr Apps as examples for medical devices

Diabetes logbook Therapy data tracking Auto-syncing with blood glucose meters Software lifecycle management must comply to ISO62304 Risk management must comply to ISO14971 Quality management according to ISO13485 recommended Low Risk - Class 1 Company prerequisites to develop a Medical Device (MDD 93/42/EEC) Defined medical intended use Therapy monitoring Compliance improvement

Bolus Calculator Insulin Dosage Calculation Influences the performance of insulin pens and pumps Inherits risk class of pens and pumps Referenced in MEDDEV documents Medium Risk class - 2b Developed according to EU Medical Device Directive 93/42/EEC Software lifecycle management must comply to ISO62304 Risk management must comply to ISO14971 Quality management according to ISO13485 required Annex certification (audit) by notified body (TÜV Süd) Company prerequisites to develop a Risk Class 2B Medical Device Defined medical intended use