Biological evaluation of medical devices. Guidance on the conduct of biological evaluation within a risk management process

2015 ◽  
Keyword(s):  
Risk Management ◽  
Medical Devices ◽  
Biological Evaluation ◽  
Management Process ◽  
Risk Management Process

ANALYSIS OF THE RISK MANAGEMENT PROCESS IN THE QUALITY MANAGEMENT SYSTEM OF AN ENTERPRISE MANUFACTURING MEDICAL DEVICES

2020 ◽  
pp. 49-55
Author(s):  
T. A. Lartseva ◽  
O. V. Aleksashina ◽  
E. V. Pak ◽  
O. N. Grinyuk
Keyword(s):  
Risk Management ◽  
Quality Management ◽  
Medical Devices ◽  
Management System ◽  
Quality Management System ◽  
Management Systems ◽  
Management Process ◽  
Process Scheme ◽  
Market Conditions ◽  
Risk Management Process

In modern market conditions, any organization, including those engaged in the production of medical devices, must identify risks, carry out their analysis, and determine the degree of their influence on the achievement of goals. This forces enterprises, on the basis of standards for management systems, standards for risk management, including taking into account the specifics of organizations, to implement a risk-based approach, creating their own risk management mechanisms. The article presents and describes in detail the basis for the methodology of the risk management process scheme in the quality management system of an organization engaged in the field of medicine.

Customisable framework for project risk management

2017 ◽  
Vol 17 (1) ◽  
pp. 68-89 ◽  
Author(s):  
Jennifer Firmenich
Keyword(s):  
Risk Management ◽  
Management Practices ◽  
New Institutional Economics ◽  
Future Research ◽  
Project Risk Management ◽  
Management Process ◽  
Project Risk ◽  
Content Type ◽  
Risk Management Process ◽  
Management Concepts

Purpose The purpose of this paper is to emphasise on the need for efficient and effective project risk management practices and to support project managers in increasing the cost certainty of projects by proposing a new framework for project risk management. Design/methodology/approach The author adopts a “constructivist” methodology, drawing on practices common in construction management sciences and new institutional economics. Findings The author presents a holistic and customisable project risk management framework that is grounded in both practice and academia. The framework is holistic because, amongst others, all steps of the typical risk management process are addressed. The framework is customisable, because it allows for alternative ways of implementing the project risk management steps depending on the project-specific circumstances. Research limitations/implications The framework does not address the potential unwillingness of the project players to set up a project risk management process, at all. The proposed framework has not yet been tested empirically. Future research will seek to validate the framework. Originality/value The framework is designed to account for the difficult circumstances of a complex construction project. It is intended to support decision makers in customising a practical yet comprehensive project risk management concept to the characteristics of the unique project. Although many other project risk management concepts are designed based on the assumption that actors are perfectly rational and informed, this framework’s design is based on the opposite assumption. The framework is dynamic and should adapt over time.

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