Company
A STORY OF PASSION AND EXPERTISE IN THE BIOMEDICAL AND PHARMACEUTICAL FIELD
NewMed Consulting Sas di Marika Ortolani & C. was born in 2020 from the experience gained in over twenty years of specific activity in the field of consulting for biomedical and pharmaceutical companies.
NewMed Consulting’s primary objective is to provide consulting services to Italian and foreign companies that manufacture, market, export, import, or distribute medical devices, and more generally, provide services aimed at the biomedical industry. These services are offered thanks to the skills developed through many years of experience.
NewMed Consulting aims to achieve full customer satisfaction by achieving the objective within the required timeframes, supporting the development of safe medical devices, planning the Quality Management System and obtaining and maintaining the related certification results.
To achieve these results, NewMed Consulting adopts a policy and a set of values that differentiate us from all other consulting firms, in the full awareness that every medical device on the market must be a safe device for users and patients.
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01.
Continuous technical and professional training and updating
Compliance with current regulations and the drafting of technical documents in the biomedical field requires constant updating, which we implement through continuous training on the latest industry developments.
02.
Professional ethics, honesty, and transparency
We believe in strict compliance with the regulatory and legislative requirements in force in the national and international territory, operating with complete transparency and honesty towards our clients.
03.
Equal partnership
with the customer
We consider our clients as equals, actively and directly involving them in every phase of our consulting phase. In this way, understanding and unity are created in achieving the objectives.
04.
Education, availability and cooperation towards the customer and all the interlocutors of the supply chain: Notified Bodies, Certification Bodies and Competent Authorities
During our consultancy, we also liaise with the relevant bodies and the Competent Authorities to ensure a comprehensive service that accompanies the client in all phases of the certification process.
05.
Proactive communication with the client and with the actors involved in the project
Over the years we have developed the ability to meet the needs of the figures involved in the project, through effective communication, active listening and creating productive collaboration.
06.
Eco-sustainable service and respect for workplace safety
We firmly believe in environmental and workplace safety. In our vision, it is essential to adopt an approach that is also eco-sustainable and respectful of workplace safety, both internally and at our clients ‘ premises.
07.
Analysis of specific business needs and service customization
Our consultancy begins with your specific requests, taking into account your company’s unique characteristics and your product design specifications. We carefully study each case to customize our service and guarantee a tailored solution.
08.
Problem solving approach
We identify the problem, understand why it arose, and assess its potential impact. In our approach, we are oriented towards researching and analyzing the root cause of the problem and develop effective solutions.
09.
Strict compliance with applicable regulatory and legislative requirements
The regulations in force in the medical and healthcare field are precise and must be strictly respected. We ensure that your project follows the regulatory and normative requirements in a compliant and precise way.
10.
Respect for privacy and absolute confidentiality of information relating to products and the know-how of client companies.
Every project we undertake is characterized by complete and absolute confidentiality: we do not disclose any information about your product, or the processes employed to create it, in full respect of your privacy.
11.
Patient safety
We are aware that every medical device on the market must be a safe device for users and patients.
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