A primer on the regulation and development of M-Health products

Regulatory Rapporteur

Volumn 14, Issue 11, 2017, Pages 4-7

  Bilek, Anastacia M ^a   Muscionico, Daniel ^a   Amiel, Christophe ^a  

^a VOISIN CONSULTING LIFE SCIENCES   (France)

Author keywords

21st century cures act; Cybersecurity; Medical device; Medical device regulation (MDR); Mobile health technologies (M health); Mobile medical app (MMA); Performance effectiveness; Quality management system (QMS); Safety; Soft ware; US FDA

Indexed keywords

MEDICAL DEVICE REGULATION; TOTAL QUALITY MANAGEMENT;

EID: 85032879397     PISSN: 17428955     EISSN: None     Source Type: Trade Journal    
DOI: None     Document Type: Article

References (13)

1. FDA. Available at: www.fda.gov/MedicalDevices/DigitalHealth/MobileMedicalApplications/ucm255978.htm
2. FDA. Available at: www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM401996.pdf
3. FDA. Available at: www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM263366.pdf
4. Health Canada. Available at: www.hc-sc.gc.ca/dhp-mps/md-im/activit/announce-annonce/md_notice_so_ ware_im_avis_logicels-eng.php
5. TGA. Available at: www.tga.gov.au/regulation-medical-so_ ware-and-mobilemedical- apps
6. MHRA. Available at: www.gov.uk/government/uploads/system/uploads/attachment_data/_ le/564745/So_ ware_flow_chart_Ed_1-02.pdf
7. Reach, Singapore. Available at: www.google.com/url?sa=t&rct=j&q=&esrc =s&source=web&cd=8&ved=0ahUKEwibn8mRxobRAhVdcFAKHXguC7EQFg hYMAc&url=https%3A%2F%2Fwww.reach.gov.sg%2F~%2Fmedia%2F2016 %2Fpc%2Fhsa%2Fproposed-regulatory-guidelines-for-telehealth-devices. pdf&usg=AFQjCNE0HB39OheXs2uKAD_6zfnVVcvIog&bvm=bv.142059868,d.ZWM&cad=rja
8. IMDRF. Available at: www.imdrf.org/docs/imdrf/_ nal/technical/imdrf-tech-151002-samd-qms.pdf#search=%22SaMD%22
9. FDA: Available at: www.fda.gov/downloads/aboutfda/centerso_ces/o_ceofmedicalproductsandtobacco/cdrh/cdrhtransparency/ucm388442. pdf
10. FDA. Available at: www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm085371.pdf
11. FDA. Available at: www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm356190.pdf
12. FDA. Available at: www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm482022.pdf
13. IMDRF. Available at: www.imdrf.org/docs/imdrf/_nal/consultations/imdrfcons-samd-ce.pdf