The European Union Medical Device Regulation (EUMDR 2017/745) requires medical device manufacturers to implement a risk-based approach to quality management system (ISO13485) processes. This article provides an overview of the importance of QMS processes in the medical device ind...
Open access
Research Article10.9734/jpri/2023/v35i137365
Surface treatment is a crucial process in the medical device industry that plays a vital role in improving the performance, durability, and safety of medical devices. This article provides an overview of the importance of surface treatment in the medical device industry. The arti...
Open access
Research Article10.9734/jpri/2023/v35i117357
This review paper aims to highlight the crucial role of ISO 10993 standards in ensuring the biocompatibility of medical devices. The use of medical devices has increased rapidly over the years, and it is essential to ensure that these devices do not cause adverse reactions or har...
Open access
Research Article10.9734/jpri/2023/v35i87342
The medical device industry is highly regulated, with a focus on ensuring the safety and effectiveness of medical devices. Risk management is a critical aspect of the medical device industry, involving the identification, assessment, and control of potential risks associated with...
Open access
Research Article10.9734/jpri/2023/v35i67330
Regulatory Affairs experts are the important part of the Medical Device industry since it is concern about the orthopaedic Implant/Instruments lifecycle, it gives key, strategic and functional bearing and backing for working inside guidelines to speed up the turn of events and co...
Open access
Research Article10.9734/cjast/2022/v41i2931797
Medical devices designed for human use can be used to help patients overcome illness or disease and improve their quality of life. Researchers are working with more difficult tasks involved in making a medical device fit for human use. This means that the device should be safe, a...
Open access
Research Article10.9734/jpri/2021/v33i60B34958
In medical device industry the risk management plays a very vital role. There should be proper communication from each and every stakeholder related to risk management of each respective department, it can be Production, Design and Development or Quality Control and all other de...
Open access
Research Article10.9734/jpri/2021/v33i31A31662
In the healthcare industry, maintaining high-quality standards is crucial to ensure the safety and efficacy of medical products. Good Manufacturing Practices (GMP) provide a set of guidelines and regulations that help ensure the consistent production, control, and quality assuran...
Open access
Research Article10.9734/jpri/2023/v35i187394
Healthcare regulation plays a crucial role in ensuring the quality and accessibility of healthcare services in Canada. This article provides an overview of the healthcare regulatory landscape in Canada, focusing on federal and provincial/territorial regulations. The federal level...
Open access
Research Article10.9734/jpri/2023/v35i187391
This research paper aims to provide a comprehensive analysis of regulatory compliance in the United States, with a specific focus on the guidelines set forth by the United States Food and Drug Administration (USFDA). Regulatory compliance plays a crucial role in ensuring the safe...
Open access
Research Article10.9734/jpri/2023/v35i177389
Regulatory compliance plays a pivotal role in the healthcare industry by ensuring patient safety, maintaining quality standards, and fostering trust between healthcare providers and patients. This research article aims to highlight the significance of regulatory compliance in hea...
Open access
Research Article10.9734/jpri/2023/v35i187390
Microbiological testing is a critical aspect of the development and evaluation of medical devices, as it plays a vital role in ensuring their safety and efficacy. This article highlights the importance of microbiological testing in medical device development and the various types...
Open access
Research Article10.9734/jpri/2023/v35i127364
The medical device industry is a critical sector that plays a vital role in healthcare delivery. Due to the nature of the work, medical device facilities are at risk of contamination from harmful microorganisms. Fogging is an essential method of disinfection that is used to eradi...
Open access
Research Article10.9734/jpri/2023/v35i47319
Sterilization is a critical aspect of the medical device industry, as the use of improperly sterilized devices can have serious consequences for patients. This article provides an overview of the risks of inadequate sterilization, the methods of sterilization commonly used in the...
Open access
Research Article10.9734/jpri/2023/v35i117358