Medical Device Apps: An Introduction to Regulatory Affairs for Developers

Journals

1. Ologeanu-Taddei R. Assessment of mHealth Interventions: Need for New Studies, Methods, and Guidelines for Study Designs. JMIR Medical Informatics 2020;8(11):e21874 View
2. Maassen O, Fritsch S, Gantner J, Deffge S, Kunze J, Marx G, Bickenbach J. Future Mobile Device Usage, Requirements, and Expectations of Physicians in German University Hospitals: Web-Based Survey. Journal of Medical Internet Research 2020;22(12):e23955 View
3. Salisbury J. Using Medical Device Standards for Design and Risk Management of Immersive Virtual Reality for At-Home Therapy and Remote Patient Monitoring. JMIR Biomedical Engineering 2021;6(2):e26942 View
4. Holfelder M, Mulansky L, Schlee W, Baumeister H, Schobel J, Greger H, Hoff A, Pryss R. Medical Device Regulation Efforts for mHealth Apps during the COVID-19 Pandemic—An Experience Report of Corona Check and Corona Health. J 2021;4(2):206 View
5. Sangers T, Wakkee M, Kramer‐Noels E, Nijsten T, Lugtenberg M. Views on mobile health apps for skin cancer screening in the general population: an in‐depth qualitative exploration of perceived barriers and facilitators*. British Journal of Dermatology 2021;185(5):961 View
6. Beardo P, Pinto R, Ayerra H, Agüera J, Armijos S, Álvarez-Ossorio J. Optimizing treatment for non muscle-invasive bladder cancer with an app. Actas Urológicas Españolas (English Edition) 2022;46(4):230 View
7. Aune A, Vartdal G, Jimenez Diaz G, Gierman L, Bergseng H, Darj E. Iterative Development, Validation, and Certification of a Smartphone System to Assess Neonatal Jaundice: Development and Usability Study. JMIR Pediatrics and Parenting 2023;6:e40463 View
8. Thiradilok S, Witayabusarakhum P, Jearnsujitwimon O, Manopatanakul S. Preferences and Satisfaction Toward an Orthodontic Clinical App. European Journal of Dentistry 2023;17(04):1283 View
9. Baines R, Hoogendoorn P, Stevens S, Chatterjee A, Ashall-Payne L, Andrews T, Leigh S. Navigating Medical Device Certification: A Qualitative Exploration of Barriers and Enablers Amongst Innovators, Notified Bodies and Other Stakeholders. Therapeutic Innovation & Regulatory Science 2023;57(2):238 View
10. Pleguezuelos-Beltrán P, Gálvez-Martín P, Nieto-García D, Marchal J, López-Ruiz E. Advances in spray products for skin regeneration. Bioactive Materials 2022;16:187 View
11. Tel A, Bordon A, Sortino M, Totis G, Fedrizzi L, Ocello E, Sembronio S, Robiony M. Current Trends in the Development and Use of Personalized Implants: Engineering Concepts and Regulation Perspectives for the Contemporary Oral and Maxillofacial Surgeon. Applied Sciences 2021;11(24):11694 View
12. Veletić M, Apu E, Simić M, Bergsland J, Balasingham I, Contag C, Ashammakhi N. Implants with Sensing Capabilities. Chemical Reviews 2022;122(21):16329 View
13. Patel B, Edwards T, Schrire T, Barnard K, Sen S. Is the Quality of Mobile Health Applications for Burns Being Adequately Assessed?. Journal of Burn Care & Research 2022;43(4):814 View
14. Praus F, Krzowski B, Walther T, Gratzke C, Balsam P, Miernik A, Pohlmann P. Smartphone Apps for Managing Antithrombotic Therapy: Scoping Literature Review. JMIR Cardio 2022;6(1):e29481 View
15. Woo J, Kim E, Kim S. The current status of breakthrough devices designation in the United States and innovative medical devices designation in Korea for digital health software. Expert Review of Medical Devices 2022;19(3):213 View
16. Aggarwal R, Visram S, Martin G, Sounderajah V, Gautama S, Jarrold K, Klaber R, Maxwell S, Neal J, Pegg J, Redhead J, King D, Ashrafian H, Darzi A. Defining the Enablers and Barriers to the Implementation of Large-scale, Health Care–Related Mobile Technology: Qualitative Case Study in a Tertiary Hospital Setting. JMIR mHealth and uHealth 2022;10(2):e31497 View
17. Alffenaar J, de Steenwinkel J, Diacon A, Simonsson U, Srivastava S, Wicha S. Pharmacokinetics and pharmacodynamics of anti-tuberculosis drugs: An evaluation of in vitro, in vivo methodologies and human studies. Frontiers in Pharmacology 2022;13 View
18. Beardo P, Pinto R, Ayerra H, Agüera J, Armijos S, Álvarez-Ossorio J. Optimización del tratamiento del cáncer de vejiga no músculo invasivo mediante una app. Actas Urológicas Españolas 2022;46(4):230 View
19. Huusko J, Kinnunen U, Saranto K. Medical device regulation (MDR) in health technology enterprises – perspectives of managers and regulatory professionals. BMC Health Services Research 2023;23(1) View
20. McIntyre R, Greenleaf W, Bulaj G, Taylor S, Mitsi G, Saliu D, Czysz A, Silvesti G, Garcia M, Jain R. Digital health technologies and major depressive disorder. CNS Spectrums 2023;28(6):662 View
21. Bini F, Franzò M, Maccaro A, Piaggio D, Pecchia L, Marinozzi F. Is medical device regulatory compliance growing as fast as extended reality to avoid misunderstandings in the future?. Health and Technology 2023;13(5):831 View
22. Talyshinskii A, Bakhman G, Hameed B, Pietropaolo A, Naik N, Somani B. Current state of mobile health apps in endourology: a review of mobile platforms in marketplaces and literature. Therapeutic Advances in Urology 2023;15 View
23. Tettey F, Parupelli S, Desai S. A Review of Biomedical Devices: Classification, Regulatory Guidelines, Human Factors, Software as a Medical Device, and Cybersecurity. Biomedical Materials & Devices 2024;2(1):316 View
24. Baik J, Famularo J. Contextual integrity of loyalty programs, compromised? Interrogating consumer health data practices and networked actors in the U.S. retail sector. Telecommunications Policy 2024;48(7):102780 View
25. Hall C, Gómez Bergin A, Rennick-Egglestone S. Research Into Digital Health Intervention for Mental Health: 25-Year Retrospective on the Ethical and Legal Challenges. Journal of Medical Internet Research 2024;26:e58939 View
26. Joala K, Kerikmäe T, Hamuľák O, Kocharyan H. Legal Framework for digital therapeutics (DTx) in the European Union. European Studies 2023;10(2):98 View
27. Han Y, Ceross A, Bergmann J. More than red tape: exploring complexity in medical device regulatory affairs. Frontiers in Medicine 2024;11 View
28. Goeldner M, Gehder S. Digital Health Applications (DiGAs) on a Fast Track: Insights From a Data-Driven Analysis of Prescribable Digital Therapeutics in Germany From 2020 to Mid-2024. Journal of Medical Internet Research 2024;26:e59013 View
29. Freyer O, Wrona K, de Snoeck Q, Hofmann M, Melvin T, Stratton-Powell A, Wicks P, Parks A, Gilbert S. The regulatory status of health apps that employ gamification. Scientific Reports 2024;14(1) View
30. Constantinou A, Hoole A, Wong D, Sagoo G, Alvarez-Valle J, Takeda K, Griffiths T, Edwards A, Robinson A, Stubbington L, Bolger N, Rimmer Y, Elumalai T, Jayaprakash K, Benson R, Gleeson I, Sen R, Stockton L, Wang T, Brown S, Gatfield E, Sanghera C, Mourounas A, Evans B, Anthony A, Hou R, Toomey M, Wildschut K, Grisby A, Barnett G, McMullen R, Jena R. OSAIRIS: Lessons Learned From the Hospital-Based Implementation and Evaluation of an Open-Source Deep-Learning Model for Radiotherapy Image Segmentation. Clinical Oncology 2025;37:103660 View
31. Kosenkov O, Elahidoost P, Gorschek T, Fischbach J, Mendez D, Unterkalmsteiner M, Fucci D, Mohanani R. Systematic mapping study on requirements engineering for regulatory compliance of software systems. Information and Software Technology 2025;178:107622 View

Books/Policy Documents

1. Agyei E, Pohjolainen S, Oinas-Kukkonen H. Persuasive Technology. View
2. Corzani M. Internet of Things for Human-Centered Design. View
3. Patel R. Pharmaceutical Care in Digital Revolution. View
4. Kumar A, Gajjar P, Gudadur K, Kumar A, Gupta A, Choudhari A, Chowdhury N, Kumar A. Applications of Biotribology in Biomedical Systems. View
5. Frestedt J. Planning, Writing and Reviewing Medical Device Clinical and Performance Evaluation Reports (CERs/ PERs). View