References

“Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and de Novo Classifications.” 2016. U.S. Food; Drug Administration. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/factors-consider-when-making-benefit-risk-determinations-medical-device-premarket-approval-and-de.

Guyatt, Gordon H., Andrew D. Oxman, Gunn E. Vist, Regina Kunz, Yngve Falck-Ytter, Pablo Alonso-Coello, and Holger J. Schünemann. 2008. “GRADE: An Emerging Consensus on Rating Quality of Evidence and Strength of Recommendations.” BMJ 336 (7650): 924–26. https://doi.org/10.1136/bmj.39489.470347.AD.

Hernán, Miguel A., and James M. Robins. 2020. Causal Inference: What If. Chapman & Hall/CRC. https://www.hsph.harvard.edu/miguel-hernan/causal-inference-book/.

“MEDDEV 2.7/1 Rev. 4: Clinical Evaluation: A Guide for Manufacturers and Notified Bodies.” 2016. European Commission. https://ec.europa.eu/docsroom/documents/17522/attachments/1/translations/en/renditions/native.

“Regulation (EU) 2017/745 on Medical Devices.” 2017. European Parliament; Council of the European Union. https://eur-lex.europa.eu/eli/reg/2017/745/oj.