European Manufacturing, Localisation and Market Access Support for IVD and Medical Devices
We help non-EU manufacturers, including companies from China and India, establish a practical European footprint through contract manufacturing, documentation support, QMS alignment and CE/MDR/IVDR readiness
Build Your European Footprint 
European production base
IVD and diagnostic expertise
QMS-driven operations
Localization and logistics support
Privacy Policy
Last updated: 06.05.2026
This Privacy Policy explains how Next Level (“we”, “us”, “our”) collects and processes personal data through the website seacnl.com.
We process personal data in accordance with Regulation (EU) 2016/679, the General Data Protection Regulation (“GDPR”), and applicable Italian data protection laws.
1. Data ControllerThe Data Controller is:
Next Level
Via Alessandro Volta, 15, 50041, Calenzano (FI), Italia
Email: info@seacnl.com
2. Personal Data We Collect
Through the contact form on seacnl.com, we may collect the following personal data:
3. Purpose of Processing
We process your personal data for the following purposes:
The legal basis for processing your personal data is:
Your personal data is processed using electronic and organisational measures designed to ensure confidentiality, integrity and security.
Access to personal data is limited to authorised persons who need the information to manage your request or provide a response.
6. Data Retention
We retain personal data collected through the contact form only for as long as necessary to manage your request and any related business communication.
Unless a longer retention period is required by law or necessary for the establishment, exercise or defence of legal claims, contact-form data will normally be retained for up to 24 months from the last interaction.
7. Data Recipients
Your personal data may be processed by:
8. Transfer of Data Outside the European Economic AreaAs a rule, we do not transfer your personal data outside the European Economic Area.
If any service providers process data outside the European Economic Area, such transfers will take place only in accordance with GDPR requirements, including adequacy decisions, Standard Contractual Clauses or other appropriate safeguards.
9. Your Rights
Under the GDPR, you have the right to:
To exercise your rights, you can contact us at:
info@seacnl.com
10. Mandatory or Optional Provision of Data
Providing your name, email address and phone number through the contact form is voluntary.
However, if you do not provide the required contact details, we may not be able to respond to your request.
11. Changes to This Privacy Policy
We may update this Privacy Policy from time to time. Any changes will be published on this page with an updated revision date.
This Privacy Policy explains how Next Level (“we”, “us”, “our”) collects and processes personal data through the website seacnl.com.
We process personal data in accordance with Regulation (EU) 2016/679, the General Data Protection Regulation (“GDPR”), and applicable Italian data protection laws.
1. Data ControllerThe Data Controller is:
Next Level
Via Alessandro Volta, 15, 50041, Calenzano (FI), Italia
Email: info@seacnl.com
2. Personal Data We Collect
Through the contact form on seacnl.com, we may collect the following personal data:
- name;
- email address;
- phone number;
- any additional information voluntarily provided in the message/request.
3. Purpose of Processing
We process your personal data for the following purposes:
- to receive and manage your request;
- to contact you in response to your inquiry;
- to provide information about our services, where relevant to your request;
- to manage pre-contractual or business communication.
The legal basis for processing your personal data is:
- your consent, when you submit the contact form and confirm that you have read this Privacy Policy;
- pre-contractual measures, where your request concerns a potential business relationship or service inquiry;
- legitimate interest, where necessary to manage business communication and respond to requests related to our activities.
Your personal data is processed using electronic and organisational measures designed to ensure confidentiality, integrity and security.
Access to personal data is limited to authorised persons who need the information to manage your request or provide a response.
6. Data Retention
We retain personal data collected through the contact form only for as long as necessary to manage your request and any related business communication.
Unless a longer retention period is required by law or necessary for the establishment, exercise or defence of legal claims, contact-form data will normally be retained for up to 24 months from the last interaction.
7. Data Recipients
Your personal data may be processed by:
- authorized internal staff;
- technical service providers involved in website hosting, maintenance, email delivery or IT support;
- professional advisors or authorities, where required by law.
8. Transfer of Data Outside the European Economic AreaAs a rule, we do not transfer your personal data outside the European Economic Area.
If any service providers process data outside the European Economic Area, such transfers will take place only in accordance with GDPR requirements, including adequacy decisions, Standard Contractual Clauses or other appropriate safeguards.
9. Your Rights
Under the GDPR, you have the right to:
- access your personal data;
- request correction of inaccurate or incomplete data;
- request deletion of your personal data;
- request restriction of processing;
- object to processing, where applicable;
- request data portability, where applicable;
- withdraw your consent at any time, without affecting the lawfulness of processing carried out before withdrawal;
- lodge a complaint with the competent supervisory authority.
To exercise your rights, you can contact us at:
info@seacnl.com
10. Mandatory or Optional Provision of Data
Providing your name, email address and phone number through the contact form is voluntary.
However, if you do not provide the required contact details, we may not be able to respond to your request.
11. Changes to This Privacy Policy
We may update this Privacy Policy from time to time. Any changes will be published on this page with an updated revision date.
Discuss Your European Manufacturing or Localisation Project
Who We Are
Next Level supports IVD, laboratory and selected medical device companies that need a reliable European base for manufacturing, localisation and regulatory readiness. We work with manufacturers, OEM partners and private label businesses preparing products for transfer, scale-up and commercialisation in Europe.
Our strength lies in combining engineering, manufacturing, quality management and documentation within one controlled project structure. This allows us to support not only production itself, but also the consistency and compliance required for regulated products.
Our strength lies in combining engineering, manufacturing, quality management and documentation within one controlled project structure. This allows us to support not only production itself, but also the consistency and compliance required for regulated products.
With more than 30 years of industry experience, expertise in automated IVD systems and certified quality processes, we provide clients with more than production capacity alone — we provide a practical route to a stronger European footprint.
30+ years
of industry background in diagnostics and regulated production
ISO-based
quality system aligned with ISO 13485 and ISO 9001 requirements
European operational
base for localization, manufacturing and documentation support
Designed to support regulated IVD production and documentation readiness
How We Support Your European Localisation
Support for product, process and know-how transfer into a controlled European production environment.
Organisation of the quality framework needed for regulated production, documentation control and operational consistency.
Assembly, pilot production, process stabilisation and preparation for batch manufacturing.
Coordination of production documentation, records, traceability and documentation flow required for regulated products.
Support with import/export, sourcing, production planning and practical localisation activities in Europe.
Support for regulatory pathway planning, documentation readiness and next-step coordination toward CE-marking and EU commercialisation.
Our Core Services
- Contract Manufacturing in the EUWe provide European-based manufacturing for diagnostic devices and laboratory automation systems, helping non-EU companies establish a reliable production footprint within the European market.OEM & Private Label SolutionsWe develop customised OEM and private label diagnostic systems by combining engineering expertise, product design and manufacturing capabilities tailored to specific customer and market requirements.Quality Management System SupportWe support production and documentation processes aligned with ISO 13485 and ISO 9001 requirements, ensuring traceability, controlled workflows and consistent product quality.EU Registration and Market Access SupportWe assist with the documentation and regulatory processes required for CE marking, MDR and IVDR readiness, helping companies prepare their products for the European market.FeaturesManufacturing and Localisation Capabilities(01)Product types
- IVD analyzers and diagnostic instruments
- Laboratory automation modules
- Instrument subassemblies and electro-medical components
- Consumables, reagent-related products and OEM / private label projects
- Selected medical devices requiring controlled production and documentation support
(02)Production stages- Incoming inspection and supplier control
- Assembly and integration
- Testing and verification
- Packaging and labeling
- Release documentation and production records
(03)Production formats- Pilot production
- Batch manufacturing
- Industrialization and scale-up support
(04)Quality controls- Process control
- Batch records
- Traceability
- Nonconformity handling
- Documentation control
Our casesALISEI Q.S. Automated IVD AnalyzerALISEI Q.S. is an automated EIA analyzer developed for medium- and large-scale laboratories and designed for high-throughput immunological testing on microplates. This type of instrumentation reflects our experience in complex IVD systems where manufacturing execution must be aligned with technical reliability, documentation discipline and quality-focused processes.
The system supports both large-scale screening and individual tests, with a total capacity of up to 540 samples across 6 microplates, up to 12 test types in a single run, and laboratory information system integration.
For projects of this level, value lies not only in production itself, but in the ability to connect controlled manufacturing, technical coordination and regulated documentation within one operational structure.
Discuss Your European Manufacturing or Localisation ProjectLeave your contact details and we will get back to you with a practical overview of possible next steps for manufacturing localisation, documentation support and EU market access readiness.