2026Paper
Lifecycle answerability for AI-enabled medical device software
Frontiers in Medicine
The closest paper to our problem statement.
Medtech
Library
Reading list.
The research, regulations and guidance we keep coming back to, each with one line on why it matters to the question of who signs.
- Sources
- 30
- Types
- 5
- Years
- 2000–2026
30 of 30 sources
2025Paper
Exploring automation bias in human-AI collaboration
Romeo, Conti · AI & Society
Review of 35 studies with modern AI.
Human factors2025Guidance
MDCG 2025-6: interplay between MDR/IVDR and the AI Act
MDCG · FAQ
How the two rulebooks stack for a device.
AI2025Report
The GenAI Divide: State of AI in Business 2025
MIT NANDA · Report
95% saw no measurable return.
Industry2024Regulation
Artificial Intelligence Act (EU) 2024/1689, amended by 2026/1744
European Union · OJ
High-risk duties for devices from 2 August 2028.
AI2024Paper
More than red tape: complexity in medical device regulatory affairs
Frontiers in Medicine
28 interviews with regulatory professionals.
Medtech2024Guidance
Predetermined Change Control Plans for AI-enabled devices
US FDA · Final guidance
Planned change for learning systems.
AI2024Regulation
Quality Management System Regulation, 21 CFR 820
US FDA · Federal Register
Incorporates ISO 13485; effective 2 February 2026.
Medtech2023Paper
Institutionalised distrust and human oversight of AI
Laux · AI & Society
Build distrust into the institution, not the individual.
Oversight2022Paper
Industry perspective on AI/ML in pharmacovigilance
Kassekert et al. · Drug Safety
Rule-based automation first, ML with caution.
Pharma2022Paper
The flaws of policies requiring human oversight of government algorithms
Green · Computer Law & Security Review
Human oversight often fails, and can launder responsibility.
Oversight2021Paper
Artificial intelligence and management: the automation-augmentation paradox
Raisch, Krakowski · Academy of Management Review
Augmentation drifts into automation and back.
Management2021Paper
Four responsibility gaps with AI
Santoni de Sio, Mecacci · Philosophy & Technology
Culpability, moral and public accountability, active responsibility.
Accountability2021Guidance
Good Machine Learning Practice guiding principles
FDA, Health Canada, MHRA · Guidance
Principle 7: human-AI team performance.
AI2020Paper
Closing the AI accountability gap
Raji et al. · FAT* 2020
An internal audit framework before deployment.
Accountability2020Paper
Essential ingredients for the implementation of Quality 4.0
TQM Journal
The quality profession's view of digital tools.
Quality2019Paper
Moral crumple zones
Elish · Engaging Science, Technology, and Society
Blame lands on the nearest human.
Accountability2019Paper
Organizational decision-making structures in the age of AI
Shrestha, Ben-Menahem, von Krogh · California Management Review
Full delegation, hybrid and aggregated structures.
Management2018Paper
AI in adverse event case processing
Schmider et al. · Clin. Pharmacol. Ther.
Nearest real analogue: AI preparing a regulated record for sign-off.
Pharma2018Paper
Meaningful human control over autonomous systems
Santoni de Sio, van den Hoven · Frontiers in Robotics and AI
Tracking and tracing conditions for control.
Oversight2017Paper
Automation bias and verification complexity
Lyell, Coiera · JAMIA
Bias rises when verification is hard, as with long records.
Human factors2017Regulation
Medical Device Regulation (EU) 2017/745
European Union · OJ L 117
Article 15: the person responsible for regulatory compliance.
Medtech2015Paper
Algorithm aversion
Dietvorst, Simmons, Massey · J. Exp. Psychol. Gen.
People abandon better algorithms after one error.
Human factors2015Guidance
EU GMP Annex 16: QP certification and batch release
European Commission · EudraLex Vol. 4
Personal signature, delegated checks, on-going assurance.
Pharma2014Regulation
Part-145, Regulation (EU) 1321/2014
EASA · OJ L 362
Certifying staff sign on behalf of the organisation.
Aviation2012Paper
Automation bias: a systematic review
Goddard, Roudsari, Wyatt · JAMIA
Wrong advice raised wrong decisions by 26%.
Human factors2011 / 2026Guidance
SR 11-7 and SR 26-2: model risk management
Federal Reserve · Supervisory guidance
Effective challenge; generative AI now out of scope.
Banking2010Paper
Complacency and bias in human use of automation
Parasuraman, Manzey · Human Factors
The classic integration of complacency and bias.
Human factors2003Book
Managing Maintenance Error
Reason, Hobbs · Ashgate
Human factors in maintenance sign-off.
Aviation2000Paper
A model for types and levels of human interaction with automation
Parasuraman, Sheridan, Wickens · IEEE Trans. SMC-A
Four stages and ten levels: automation is not yes or no.
Automation