Zwei Personen arbeiten an der Medizintechnik | LGI

LGI offers a complete solution:

Reliable Logistics for In-Vitro Diagnostics

  • Customized logistics solutions for medical devices
  • Certified – to the highest standards
  • Expert in in-vitro diagnostics

In-Vitro Diagnostics (IVD): Meaning & Areas of Application

In-vitro diagnostics include procedures in which extracted body fluids – such as blood or urine – are analyzed under laboratory conditions.
Modern diagnostic systems have long been specialized for highly sensitive detection. With in-vitro test kits, date-rape drugs, vitamin B6, or rare metabolic markers can be reliably detected in the laboratory. Developed through close cooperation between research and industry, they are used in central laboratories, research institutions, and increasingly directly at the patient’s side.

Point-of-care solutions, for example for monitoring immunosuppressants after organ transplants, exemplify the shift towards networked, decentralized testing procedures. The development of such systems requires interdisciplinary collaboration. The demands on functionality, precision, and integration are increasing rapidly.

Reliably Storing, Delivering & Retrieving In-Vitro Diagnostics

Whether HIV rapid tests, PAP smear kits, or reagents for blood analysis – when it comes to in-vitro diagnostics, the highest precision counts. The requirements for storage, transport, and retrieval are complex, as they involve sensitive products with clearly defined temperature ranges and strict approvals. We develop customized logistics concepts that cover large parts of your value chain – from warehousing and fine distribution to the retrieval of consumables and spare parts. In doing so, we strictly adhere to legal requirements and operate according to certified quality standards. Together, we create healthcare solutions that strengthen your processes – and bring your products safely to their destination.

We Bring Your In-Vitro Diagnostics Safely to Their Destination

  • What we do: For a leading manufacturer of analytical measuring instruments, we handle the global distribution, procurement, and reverse logistics of devices and spare parts. We also operate a consignment and cold storage facility as well as a cross-dock.
  • Where we do it: Over an area of 30,000 m² in our logistics center for large medical technology devices, spare parts, and consumables.
  • How we do it: Aligned with the highest quality standards – we are certified according to DIN EN ISO 13485 and qualified according to Good Distribution Practice (GDP).

In-Vitro Diagnostics: Legal Regulations & Approval

The EU regulation IVDR imposes stringent requirements on the manufacturing, approval, and distribution of in-vitro diagnostics. Anyone distributing IVD products must prove their safety, intended purpose, and traceability – and seamlessly document the entire supply chain.

Where sensitive diagnostics are on the move, a single set of rules is not enough: The Medical Device Act (MPG) supplements the IVDR and clearly prescribes how products may be stored, tested, and transported. Before an IVD can enter the market, it must pass the conformity assessment procedure. It is a testing marathon that proves the product delivers what it promises and meets every regulatory requirement.
We support you with IVDR-compliant processes and ensure that your products arrive safely, traceably, and in compliance with the law:

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PRECISELY MAINTAINING TEMPERATURE RANGES

From refrigerated to deep-frozen – we create stable conditions for sensitive diagnostics.

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SEAMLESS BATCH TRACKING

Every unit remains traceable – from the warehouse to delivery.

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SHIPPING ACCORDING TO IVDR STANDARD

Clear labeling, secure packaging, legally compliant transport.

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CERTIFIED AT ALL LEVELS

According to ISO 13485, ISO 14971 and Good Distribution Practice (GDP).

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REQUIREMENTS OF THE MPG

We keep an eye on CE marking, documentation obligations, and official controls.

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READY FOR SPECIAL CASES

Whether Point-of-Care, self-testing, or in-house IVD – we know the differences and react with appropriate solutions.

Business Cases

Our Logistics Solutions for In-Vitro Diagnostics

  • Cross Dock: We temporarily store goods, consolidate incoming deliveries, and send them bundled on demand to other distribution centers.
  • Demo Pool Management: We take over the all-round supply for your test devices, including the assembly of highly sensitive devices directly at the deployment site.
  • Distribution Logistics: We know how the fine distribution of spare parts and consumables to laboratories, research institutions, and medical facilities works, just as well as the global shipping of large quantities to other distribution centers.
  • Dangerous Goods Handling: We bring dangerous goods and even radioactive products (ECD components) safely to their destination.
  • Production Logistics: We supply production, thereby reducing inventories and lead times while increasing production flexibility.
  • Temperature Logistics: We offer temperature-monitored warehousing and temperature-controlled shipping for products with different climate zones, such as +2 to +8°C and down to -80°C.
  • Value Added Services: We organize deliveries for trade fairs & events including the preparation of devices and subsequent data deletion, assemble individual components into kits, develop innovative packaging, and much more.
  • Customs and Foreign Trade: We handle export clearance and monitoring of export certificates as well as import processing for you.

Our Certifications for Healthcare Logistics

We know how important reliability is in the healthcare sector. That is why we have our work regularly audited – and adhere to the highest standards.

What Our Customers Say

Efficiently Organized In-Vitro Diagnostics: Your Advantages

  • Our efficiency: Optimal warehousing, clean processes, and a LEAN management system that continuously refines where it makes sense.
  • Years of process and product expertise: We optimize your warehousing and distribution processes – with our expertise in medical technology and best-practice experience from other industries.
  • New services that drive you forward: From smart packaging solutions to pre-assembled components – we are constantly expanding our offering so that your processes run even more smoothly.
  • Providing impulses for tomorrow: Our innovation workshops bring fresh ideas and concrete approaches for solutions that are geared to your market and your requirements.

Whether storage, retrieval, or distribution: Precision, speed, and compliance count in in-vitro diagnostics. We provide end-to-end certified logistics – adapted to your products, your processes, and your requirements. Let’s talk about your supply chain.

Frequently Asked Questions About In-Vitro Diagnostics Logistics

What is meant by in-vitro diagnostics?

In-vitro examination includes procedures in which extracted body fluids – such as blood or urine – are analyzed under strictly controlled laboratory conditions. The aim is to detect specific markers that provide indications of diseases or the progress of therapies. The results are reliable and have long been indispensable in everyday medical practice.

What does “in vitro” mean?

“In vitro” (Latin for “in glass”) refers to examinations that take place outside the body under laboratory conditions. Extracted samples are analyzed without intervening in the organism itself. The term is distinguished from “in vivo,” which refers to procedures that are carried out clinically, i.e., directly in the human body.

What is an example of an in-vitro diagnostic?

Typical products include HIV rapid tests, PAP smear kits, reagents for blood group analysis, or blood glucose test strips. Apparatus and analysis equipment – in vitro diagnostic medical devices (IVDs) – also fall into this category, provided they are intended for the examination of human samples outside the body. General laboratory articles without a specific diagnostic purpose are not included.

What are in-vitro values?

Laboratory analyses provide precise values for specific parameters in the body – obtained from extracted samples such as blood or urine. These so-called in-vitro values indicate, for example, hormone levels, antibodies, genetic markers, or infections. They are medically relevant and crucial for diagnoses, the progress of therapies, or preventive examinations.

How reliable are in-vitro diagnostics – especially self-tests?

Approved in-vitro diagnostics, including those for home use, must meet strict requirements. Their CE marking presupposes that they have been tested and evaluated in validated procedures. Reliable results require correct application. If self-tests are used correctly, they work reliably – especially with a clear indication and defined target group.

What happens to the collected health data after an in-vitro test?

After an in-vitro test, the health data is stored in encrypted form – specifically in a highly secure network of the German healthcare system, the so-called telematics infrastructure. Only registered medical professionals and healthcare facilities with appropriate authorization have access to it. Patients themselves decide who is allowed to access their data – and for what purpose.

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