Processing of health care products. Information to be provided by the medical device manufacturer for the processing of medical devices

INTRODUCTION:National Health Technology Assessments (HTAs) for medical devices are crucial to regulate the quality and costs of healthcare systems. However, there is diversity in several aspects among European countries. Consequently, controversial results might arise, generating contrary reimbursement decisions. The European Network for Health Technology Assessment (EUnetHTA) is an interface platform for the harmonization of HTA information across Europe. The European Commission expects national uptake of a European HTA. Thus, European HTAs might overcome the diversity of national HTA requirements.METHODS:We aimed to compare German and European HTAs for medical devices regarding processes, methods, timelines, and involvement of medical device companies. Therefore we analyzed guidelines, requirements, and output of EUnetHTA and compared those aspects with the German G-BA (Federal Joint Committee, Gemeinsamer Bundesausschuss) standard and IQWiG (Institute for Quality and Efficiency in Health Care, Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen) methods.RESULTS:We found differences between the European and German HTAs for medical devices regarding timelines, involvement of medical device companies, body of evidence, use of surrogate endpoints, and methodology. European HTAs for medical devices reflect the clinical reality by integrating the existing evidence (including real world data) and by using comprehensive statistical methods for medical devices. In contrast, German HTAs for medical device-based technologies are long lasting and are often restricted to a small body of evidence.CONCLUSIONS:As a conclusion, similar to pharmaceuticals, the European HTA framework might also become a worldwide platform for HTAs of medical device-based technologies with the potential to harmonize reimbursement decisions and patients health care across countries on the basis of clinical reality.

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Trends in software as a medical device (Preprint)

10.2196/preprints.20652 ◽

2020 ◽

Author(s):

Aaron Ceross ◽

Jeroen Bergmann

Keyword(s):

Health Care ◽

Data Analysis ◽

High Risk ◽

Adverse Events ◽

Medical Device ◽

Empirical Analysis ◽

Medical Devices ◽

Digital Revolution ◽

The Us ◽

Software Registration

UNSTRUCTURED Software-as-a-medical-device (SaMD) has gained popularity as a type of medical device. However, to date, empirical analysis of SaMD trends have been lacking. Using databases managed by the US medical device regulator (the Food and Drug Administration), we map the path SaMD takes towards classification and recorded adverse events. The findings show that while SaMD has been identified in literature as an area of development, the data analysis suggests that this growth has been modest. These devices are overwhelming classified as moderate to high risk and they take a very particular path to that classification. The digital revolution in health care is less pronounced when evidence is considered of SaMD. In general, the trend for software registration mimics that of medical devices.

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Handling of Medical Devices: Reforms and Regulations

Journal of Pharmaceutical Research International ◽

10.9734/jpri/2021/v33i60a34520 ◽

2021 ◽

pp. 565-572

Author(s):

M. Charmila ◽

M. P. Venkatesh ◽

G. Ramya Shree

Keyword(s):

Patient Care ◽

Medical Device ◽

Medical Devices ◽

Human Factor ◽

Family Members ◽

Medical Community ◽

Human Factor Engineering ◽

Regulatory Authorities ◽

Device Manufacturer ◽

At Home

With the evolving technology and changing regulations, the medical device sector is set to grow quickly soon. Even though they are an integral part of patient care they present several unique problems which are not sufficiently addressed by the device manufacturer or the medical community in general. Medical device is widely used by professionals in a clinical setup, by patients, family members at home. As step towards better understanding the rules, regulations, and the required reforms for the safe use of medical devices various measures taken by different regulatory authorities to ensure the minimization of use error are discussed. Human factor engineering and ergonomics are considered while designing a medical device. It is evident that all the stakeholders involved contribute to the safety of the medical device keeping in mind the welfare of the patient but is that enough and what can be done is discussed in this review work.

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Quality Assurance in Medical Devices

Handbook of Research on Technology Applications for Effective Customer Engagement - Advances in Marketing, Customer Relationship Management, and E-Services ◽

10.4018/978-1-7998-4772-4.ch019 ◽

2021 ◽

pp. 302-314

Author(s):

Juliana Shaibun

Keyword(s):

Quality Assurance ◽

Medical Device ◽

Medical Devices ◽

High Performance ◽

Quality Management System ◽

Business Environment ◽

Future Research ◽

Medical Device Manufacturers ◽

Device Manufacturer ◽

Assurance Process

Quality management system (QMS) is acknowledged as the primary method for any manufacturer, especially medical device manufacturers, in order to sustain the product quality in the competitive advantage in business environment. QMS is an essential requirement for regulatory control in high risk medical devices. Globally, the number of medical device manufacturers certified by ISO 13485 is escalating. Ownership of this certification symbolizes the medical device manufacturer acquired high performance in their QMS. This bibliometric provides a brief review of the quality assurance and how safety plays an important role in medical devices. Bibliometric analysis guided user to summarize the essential part of quality assurance process in medical device. The insights presented in this research assist in building a firm theoretical base and direction for future research.

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Medical devices biomaterials – A review

Proceedings of the Institution of Mechanical Engineers Part L Journal of Materials Design and Applications ◽

10.1177/1464420719882458 ◽

2019 ◽

Vol 234 (1) ◽

pp. 218-228 ◽

Cited By ~ 1

Author(s):

AJ Festas ◽

A Ramos ◽

JP Davim

Keyword(s):

Health Care ◽

Life Expectancy ◽

Medical Device ◽

Population Health ◽

Medical Devices ◽

Methods And Techniques ◽

Manufacturing Methods ◽

Proper Material ◽

Care Demands ◽

Metal Polymer

Due to the increase in the life expectancy of world’s population, health care demands in terms of quality and accessibility are higher than ever before. Concerning the manufacturing of medical devices, the development of new biomaterials, new manufacturing methods and techniques have always been on researchers focus. In the development of a medical device, the choice of the proper material to be used is of the most importance, since its ability and capacity to fulfil the expected function will determine the success of the medical device itself. This work aims to do a review of those that are the most commonly used biomaterials. After an explanation on what are biomaterials and what defines them, a more in-depth approach is presented to each of the four major types of biomaterials: metal, polymer, ceramic, and composites, where their main characteristics and preferred applications in the area of medical devices are described.

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