Integrated diabetes healthcare Frank Westermann CEO my Sugr

Integrated diabetes healthcare Frank Westermann CEO my. Sugr Gmb. H frank. westermann@mysugr. com

COMPANY Founded 2012 120, 000 users 20 Employees (8 with Type 1 Diabetes) Offices in Vienna & San Francisco CE marked & FDA registered TÜV certified processes (ISO 13485)

MYSUGR APPS AS EXAMPLES FOR MEDICAL DEVICES

DIABETES LOGBOOK herapy data tracking • Auto-syncing with blood glucose meter Company prerequisites to develop a Medical Device (MDD 93/42/EEC) • Software lifecycle management must comply to ISO 62304 • Risk management must comply to ISO 14971 • Quality management according to ISO 13485 recommended Defined medical intended use • Therapy monitoring • Compliance improvement LOW RISK - CLASS 1

BOLUS CALCULATOR Insulin Dosage Calculation Company prerequisites to develop a Risk Class 2 B Medical Device • • • Developed according to EU Medical Device Directive 93/42/EEC Software lifecycle management must comply to ISO 62304 Risk management must comply to ISO 14971 Quality management according to ISO 13485 required Annex certification (audit) by notified body (TÜV Süd) Defined medical intended use • Influences the performance of insulin pens and pumps • Inherits risk class of pens and pumps • Referenced in MEDDEV documents MEDIUM RISK CLASS -