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The regulation, assessment, and management of medical devices in Mexico: How do they shape the quality of delivered healthcare? [PDF]
, 2017 Background: Policies for health technologies such as medical devices are essential and contribute to improved quality of healthcare. The regulation, assessment, and management represent important functions of medical devices.
Dreser Mansilla, Anahi +3 more
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Medical Device Apps: An Introduction to Regulatory Affairs for Developers
JMIR mHealth and uHealth, 2020 The Poly Implant Prothèse (PIP) scandal in France prompted a revision of the regulations regarding the marketing of medical devices. The new Medical Device Regulation (MDR [EU]) 2017/745 was developed and entered into force on May 25, 2017.
Keutzer, Lina, Simonsson, Ulrika SH
doaj +1 more source
BMC Pregnancy and Childbirth, 2023 Background Preimplantation genetic testing for aneuploidy (PGT-A) was demonstrated to be superior to conventional IVF in reducing the incidence of miscarriage and abnormal offspring after the first embryo transfer (ET).
Yan-Fei Cheng +19 more
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Frontiers in Bioengineering and Biotechnology, 2019 Medical devices are designed, tested, and placed on the market in a highly regulated environment. Wearable sensors are crucial components of various medical devices: design and validation of wearable sensors, if managed according to international ...
Alice Ravizza +5 more
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Relationship Between EU Membership & UK Medical Device Innovation [PDF]
, 2015 Thirty-eight million people contact a medical device every day in the UK. The UK has over 3000 companies employing 76 000 people in medical technology.
Browning, Paul, Rowell, T.
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3D bioprinting regulations: a UK/EU perspective [PDF]
, 2017 This section introduces the challenges 3D bioprinting poses to the existing legal regime across bioethics, safety, regenerative medicine, and tissue engineering.
Faulkner, Alex, Li, Phoebe
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Systems and processes for regulation of investigational medical devices in Uganda
Frontiers in Medical Technology, 2023 BackgroundIn many parts of the world, medical devices and the processes of their development are tightly regulated. However, the current regulatory landscape in Uganda like other developing countries is weak and poorly defined, which creates significant ...
Charles Norman Mpaata +10 more
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Outstanding questions concerning the regulation of enhancement devices [PDF]
, 2014 The authors (Maslen et al., 2014) propose to regulate cognitive enhancement devices (CEDs) as medical devices. Extending medical device regulations to CEDs raises some important questions that need to be adequately addressed before it makes sense to ...
De Ridder, Dirk +2 more
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Precaution, governance and the failure of medical implants: the ASR(TM) hip in the UK [PDF]
, 2014 Hip implants have provided life-changing treatment, reducing pain and improving the mobility and independence of patients. Success has encouraged manufacturers to innovate and amend designs, engendering patient hopes in these devices.
Joyce, Thomas +2 more
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China's Particle Therapy Equipment Market: Opportunities Outweigh Challenges
Frontiers in Public Health, 2020 Since 2019, China has been the second largest medical device market in the world. At present, high-end radiotherapy equipment such as particle therapy system has a huge market potential due to the grim situation of cancer prevention and control and the ...
Zhongying Dai, Yuanyuan Ma, Qiang Li
doaj +1 more source