Nexo Corporation is by your side, offering expertise, experience and reliability to support the development and execution of projects in the biomedical sector.
Our expert teams help you identify the most effective solutions to achieve your goals, exploring every possibility and crafting strategies tailored specifically to meet your needs.
What sets us apart:
🔹 Extensive know-how, enhanced by academic backgrounds and medical-scientific specialisations;
🔹 Hands-on experience, gained through close collaboration with companies in the field;
🔹 Ongoing cooperation, ensuring open, constructive dialogue and shared goals;
🔹 Continuous learning, keeping our skills current and aligned with the latest market trends.
Researching, evolving, and innovating are part of our DNA. That’s why our mission is to provide you with a solid foundation, train your team, and equip you with the tools needed to operate independently — knowing you can always count on us — discreetly, yet dependably.
Your success is our success.
What sets us apart:
🔹 Extensive know-how, enhanced by academic backgrounds and medical-scientific specialisations;
🔹 Hands-on experience, gained through close collaboration with companies in the field;
🔹 Ongoing cooperation, ensuring open, constructive dialogue and shared goals;
🔹 Continuous learning, keeping our skills current and aligned with the latest market trends.
Researching, evolving, and innovating are part of our DNA. That’s why our mission is to provide you with a solid foundation, train your team, and equip you with the tools needed to operate independently — knowing you can always count on us — discreetly, yet dependably.
Your success is our success.
Regulatory Department – Nexo Medical Devices Consulting
The regulatory landscape is constantly shifting and evolving. New regulations, directives, standards and guidelines are constantly being revised or introduced.
As a result, Businesses are becoming increasingly overwhelmed by documentation demands.
We support you throughout each stage of the regulatory process:
🔹 Classification of devices and management of borderline products, in accordance with the current regulations
🔹 Feasibility studies for certification and technical documentation reviews (TD, TF, STED)
🔹 Management of clinical and laboratory testing, including definition of worst-case devices
🔹 Communication with notified bodies, competent authorities and accredited laboratories
🔹 Risk assessment and management, labelling and preparation of instructions for use
🔹 Clinical, biological and usability evaluations, including post-market investigations and follow-ups
🔹 Development of post-market surveillance plans and incident reporting procedures
🔹 Assumption of the Oversight Manager role, and registration of devices and facilities internationally
🔹 Support for 510(k), PMA and IDE submissions for the US market
🔹 Implementation of the UDI system and facilitation of entry into new markets
We support you throughout each stage of the regulatory process:
🔹 Classification of devices and management of borderline products, in accordance with the current regulations
🔹 Feasibility studies for certification and technical documentation reviews (TD, TF, STED)
🔹 Management of clinical and laboratory testing, including definition of worst-case devices
🔹 Communication with notified bodies, competent authorities and accredited laboratories
🔹 Risk assessment and management, labelling and preparation of instructions for use
🔹 Clinical, biological and usability evaluations, including post-market investigations and follow-ups
🔹 Development of post-market surveillance plans and incident reporting procedures
🔹 Assumption of the Oversight Manager role, and registration of devices and facilities internationally
🔹 Support for 510(k), PMA and IDE submissions for the US market
🔹 Implementation of the UDI system and facilitation of entry into new markets
Quality – Nexo Medical Devices Consulting
Our Quality department offers comprehensive, tailored support:
🔹 QMS design, implementation and maintenance in compliance with ISO 13485 and ISO 9001
🔹 Drafting of the Quality Manual and formulation of the Quality Policy
🔹 Assistance during inspections by Notified Bodies and Competent Authorities
🔹 Evaluation of the internal quality system and those of suppliers and distributors
🔹 Training in quality management, regulatory compliance and validation procedures
🔹 Creation and implementation of SOPs
🔹 Management of non-conformities and CAPA processes
🔹 Planning and oversight of post-market surveillance (PMS) activities.
🔹 Development of systems for data collection and documentation
With Nexo, quality means control, continuous improvement, and international recognition.
🔹 QMS design, implementation and maintenance in compliance with ISO 13485 and ISO 9001
🔹 Drafting of the Quality Manual and formulation of the Quality Policy
🔹 Assistance during inspections by Notified Bodies and Competent Authorities
🔹 Evaluation of the internal quality system and those of suppliers and distributors
🔹 Training in quality management, regulatory compliance and validation procedures
🔹 Creation and implementation of SOPs
🔹 Management of non-conformities and CAPA processes
🔹 Planning and oversight of post-market surveillance (PMS) activities.
🔹 Development of systems for data collection and documentation
With Nexo, quality means control, continuous improvement, and international recognition.
Verification and Validation – Nexo Medical Devices Consulting
Have you designed your device correctly? Have you designed the right device?
To answer these questions, a structured Verification and Validation (V&V) process is essential.
Verification demonstrates, through objective evidence (e.g. testing), that the design outputs meet the specified requirements.
Validation ensures the device meets the user's needs and achieves its intended purpose.
But there’s more: the processes themselves must also be validated.
When the results cannot be confirmed through simple inspections (e.g. destructive testing), or when control costs are excessively high, Process Validation becomes crucial.
It ensures each process consistently delivers compliant results, enhancing efficiency, reducing errors and speeding up time-to-market.
Our Verification and Validation department supports you throughout all the following stages:
🔹 Establishment of the Design Inputs based on the regulatory requirements and risk analysis
🔹 Development of test strategies for product, process and software Verification and Validation
🔹 Preparation of the technical documentation (V&V Plan and Report, QI, QO, QP)
🔹 Creation and updating of the Design History File (DHF)
To answer these questions, a structured Verification and Validation (V&V) process is essential.
Verification demonstrates, through objective evidence (e.g. testing), that the design outputs meet the specified requirements.
Validation ensures the device meets the user's needs and achieves its intended purpose.
But there’s more: the processes themselves must also be validated.
When the results cannot be confirmed through simple inspections (e.g. destructive testing), or when control costs are excessively high, Process Validation becomes crucial.
It ensures each process consistently delivers compliant results, enhancing efficiency, reducing errors and speeding up time-to-market.
Our Verification and Validation department supports you throughout all the following stages:
🔹 Establishment of the Design Inputs based on the regulatory requirements and risk analysis
🔹 Development of test strategies for product, process and software Verification and Validation
🔹 Preparation of the technical documentation (V&V Plan and Report, QI, QO, QP)
🔹 Creation and updating of the Design History File (DHF)
Patents, Trademarks & Design – Nexo Medical Devices Consulting
PATENTS
Today, over 90% of the value of large enterprises is tied to intangible assets, with patents at the forefront. A well-drafted patent protects your innovation, prevents competitor misuse and offers key strategic benefits:
🔹 Market exclusivity.
🔹 Enhanced appeal and brand reputation.
🔹 Monetary value through sales, licensing or royalties.
In collaboration with qualified consultants, Nexo supports you with:
🔹 Technical drafting and filing of patents (Italy, EU, international)
🔹 Global extensions through a network of local experts
🔹 Management of examinations, prosecutions and oppositions
🔹 Analysis of conflicts and advice on counterfeiting issues
🔹 Validity assessments and state-of-the-art research
🔹 Support with cancellations and legal proceedings in Italy and abroad
TRADEMARKS
A trademark represents far more than a name — it embodies identity, credibility and brand value. Protecting it ensures your products and services remain unique, recognisable and secure.
We offer:
🔹 Filing and registration in Italy, across Europe, and internationally
🔹 Oppositions, market analysis and prior rights research
🔹 Monitoring of similar or competing trademarks
🔹 Legal action against counterfeiting and unfair competition
DESIGN
Strong design is a powerful competitive edge. But without protection, a design can easily be imitated.
Registering a design grants exclusive rights for up to 25 years.
Nexo supports you with:
🔹 National, European and international design registration
🔹 Conflict analysis and prior design searches
🔹 Oppositions, enforcement actions and sector-specific monitoring
🔹 Tailored services with global protection strategies
Today, over 90% of the value of large enterprises is tied to intangible assets, with patents at the forefront. A well-drafted patent protects your innovation, prevents competitor misuse and offers key strategic benefits:
🔹 Market exclusivity.
🔹 Enhanced appeal and brand reputation.
🔹 Monetary value through sales, licensing or royalties.
In collaboration with qualified consultants, Nexo supports you with:
🔹 Technical drafting and filing of patents (Italy, EU, international)
🔹 Global extensions through a network of local experts
🔹 Management of examinations, prosecutions and oppositions
🔹 Analysis of conflicts and advice on counterfeiting issues
🔹 Validity assessments and state-of-the-art research
🔹 Support with cancellations and legal proceedings in Italy and abroad
TRADEMARKS
A trademark represents far more than a name — it embodies identity, credibility and brand value. Protecting it ensures your products and services remain unique, recognisable and secure.
We offer:
🔹 Filing and registration in Italy, across Europe, and internationally
🔹 Oppositions, market analysis and prior rights research
🔹 Monitoring of similar or competing trademarks
🔹 Legal action against counterfeiting and unfair competition
DESIGN
Strong design is a powerful competitive edge. But without protection, a design can easily be imitated.
Registering a design grants exclusive rights for up to 25 years.
Nexo supports you with:
🔹 National, European and international design registration
🔹 Conflict analysis and prior design searches
🔹 Oppositions, enforcement actions and sector-specific monitoring
🔹 Tailored services with global protection strategies
Through a network of specialised professionals, we provide complete technical and legal assistance to safeguard your industrial property, in Italy and worldwide.
Entrust Nexo with the protection of your innovation — secure tomorrow’s value today.
Entrust Nexo with the protection of your innovation — secure tomorrow’s value today.
