Comparison of the international regulations for medical devices–USA versus Europe
Matthias Fink, Bassil Akra
Topics & Concepts
Food and drug administrationMedical deviceBusinessRegulatory authorityMember statesRegulatory scienceEuropean unionQuality (philosophy)Risk analysis (engineering)MedicineInternational tradePublic administrationPolitical sciencePhilosophyBiomedical engineeringEpistemologyPathologyOrthopaedic implants and arthroplastyCardiac, Anesthesia and Surgical OutcomesHealth Systems, Economic Evaluations, Quality of Life