Consulting Services
for the Biomedical Industry
PROVIDING SERVICES TO MEDICAL, BIOMEDICAL, AND PHARMACEUTICAL COMPANIES
Founded in 2020 with years of experience, NewMed Consulting provides consulting services focused on the medical and pharmaceutical industry, including Quality Management Systems to CE marking, and the drafting of technical product documentation.
NewMed Consulting provides competent and professional support to medical and biomedical companies in achieving their corporate objectives of certification and adaptation of their processes and products to the regulatory requirements in force in Italy, Europe and international target markets.
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Discover our Company
COMPETENCE
Extensive and profound technical expertise in the sector and its certification complexities.
EXPERIENCE
With over 20 years of experience in the sector, we have honed our ability to tackle and solve even the most complex problems.
RELIABILITY AND ETHICS
We care about our customers’ certification goals within sustainable times and costs. We believe in strict compliance with regulatory and legislative requirements.
OVER THE YEARS
NewMed Consulting has supported numerous companies in achieving their goals. Since the company was founded in 2020, we have helped over 30 companies achieve certification results.
Client companies
Certified devices
System certificates
Managed audits (internal and external)
Consulting services for the Biomedical Industry
NewMed Consulting’s advisory service supports you in all phases that lead to the marketing of a medical product. We start with the design process and see it through to production, always monitoring for potential risks and ensuring that the final product is safe for both the patient and the user, as well as environmentally friendly.
To make this happen, we actively support you in obtaining the required certifications and preparing the necessary technical/regulatory documentation.
Quality Management Systems
We ensure that business processes are aligned with ISO requirements to guarantee the provision of medical devices and services that meet customer expectations and applicable regulatory standards.
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European Medical Device Certification
We support our clients in demonstrating compliance with European regulations to obtain the CE marking.
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Regulatory and normative requirements
We offer Regulatory Affairs and Gap Analysis services to ensure that all your devices meet the required standards.
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Product technical documentation
We implement the Technical Documentation in accordance with Annex II of Regulation (EU) 2017/745.
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Explore all the NEWS
We are constantly updated on the latest developments in the industry to be able to provide you with advice that takes into account the changes that occur in the regulatory and technological fields.
Check out our articles for the latest news!
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