QUALITY MANAGEMENT AND RISK MANAGEMENT SYSTEMS
A QUALITY PRODUCT IS ALSO A SAFE PRODUCT
One of our goals is to support you in the design phase of your medical device, ensuring its compliance with all applicable standards and regulations, and assessed on the basis of all possible risks
NewMed Consulting has over twenty years of experience in quality management consulting. This term refers to compliance with the ISO 13485 and ISO 9001 standards, which are internationally recognized reference standards for quality management systems.
Risk management is essential in the design of a medical device. It is necessary to ensure that the device is produced only after careful assessment of the risks associated with its use, the potential harm it could cause, its severity and the probability that they may occur. We will assist you in the preparation of the Risk Management File, which concerns the processes implemented for risk management
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European Commission
EU Regulation 2017/745 MDR
Italian Ministry of Health
Implementation and optimization of Quality Management Systems according to ISO 13485 and ISO 9001 based on the specific needs of the customer
Implementation and optimization of Quality Management Systems according to ISO 13485 and ISO 9001 based on the specific needs of the customer
Manufacturing process planning and control of medical devices
Implementation of quality management systems for Extra EU Regulations adhering to the MDSAP program and customer support for MDSAP audit management
Internal and external audits to verify the quality management system in compliance with ISO 13485 and ISO 9001 standards
Client support during audits by Notified Bodies, Certification Bodies and Competent Authorities
Training activities
Management of medical device sterilization processes
YOUR JOURNEY WITH US
Designing and certifying a medical device requires knowledge and expertise, essential qualities that you can find in NewMed Consulting. Starting from your specific needs, we support you in the project through in-depth consultancy. After the implementation of the service, it is our duty to help you achieve the certification results required by law. We act in the certainty of satisfying your experience with us.
To achieve all this, we are committed to continuous training that allows us to stay updated on new directives and ensure a professional and well-prepared service.
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