Technical Solutions by LRE Medical in Munich

Inte
grating
expertise to provide
success

We are the proven, reliable partner for the realization of highly technical diagnostic devices. With concentrated solution competence, a high vertical range of manufacture and a morphological exchange of knowledge and insights, we engineer the progress that our customer’s wish to achieve.

LRE works like clockwork – corresponding with our values of punctuality, precision and reliability, which are reflected in the world-famous quality feature Made in Germany. But also, because at LRE, in a well thought-out process our departments interlock intelligently and efficiently. This highly integrated approach of knowledge and technical know-how enables us to combine experience and ambition towards our own perfectionist standards.

The goal-oriented cycle

Always conscientious and quality-conscious: We completely meet our customers’ needs by providing them tailor-made solutions, designed and engineered to always be compliant with regulatory standards. In our fullservice approach that extends from the initial idea to the finished, validated diagnostic device produced in series, we exhibit utmost flexibility. This includes flexible project entry points and the possibilities to make adjustments along the way of the product life cycle, allowing for continuous optimization through a close cooperative partnership.

Follow the cycle and find out how LRE creates the ideal solution for you.

Making the complicated simple

Whether it’s the partnership, the joint development process, or the ease of use of the final product, at LRE we make the complicated things simple. Many market leaders already trust in these qualities – and have entrusted us for over 60 years with the production of their diagnostic devices.

We provide full service for development and realization: Contract Engineering and Contract Manufacturing.

Idea

Where the project begins.

With LRE, an intensive and successful partnership usually begins with this idea. Because just as all departments are interlinked with each other, we also link our customers with each of our departments. This creates a close cooperation, characterized by a morphological approach that connects further ideas, input, feedback and optimization processes towards the realization of the ideal diagnostic device.

Providing solutions holistically

Along with the idea wishes, requirements and the general framework are presented. Our experts from the systems engineering and production engineering departments analyze the requirements and clarify the feasibility of the project. This is the starting point of the realization process, in which we take all elements, parameters, and possible solutions into considerations. What follows is the generation of comprehensive solution approaches, which are presented using a decision matrix for feasibility and cost-effectiveness.

Systems engineering

From the smallest component to the synergy of all parts to the finished, state-of-the-art diagnostic device: the systems engineering department is responsible for the holistic development of new products. This includes full consulting support throughout the entire product life cycle, e.g. through optimization processes initiated by input from other departments.

Translating customer needs into
product specifications

A thorough understanding of the customer’s requirements regarding application, end user needs and business processes supports the next levels of requirements:

  • Determination of the functionality of the final solution
  • Detailing the specifics about how the solution will be created to achieve the design goals in a technical specification and determination of the scope of work and development tasks.

Development and design

The great strength of our systems engineering department is the deep systematic understanding and approach within the topic. Our development experts are thus able to define the requirements of the overall system in its individual areas in order to bring the big picture together even in the most limited space. This ability of highly integrated miniaturization is a significant quality that we achieve through sophisticated design and extensive engineering knowledge.

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When it comes down to design, we follow two basic principles:

  1. Design for robustness
    The solutions we built need to be sturdy and must prove their quality during a long life cycle. Therefore, we always identify critical characteristics (CTQs) that quantify customer requirements and at the same time look for ways to reduce variation in CTQs.
  2. Design for manufacturing
    It is crucial that plausibility for the design is checked continuously during the development phase. Being a product developer AND experienced manufacturer, this comes naturally to us. The advantage for our customers: We only design products that can be built the exact way it has been designed. Feasibility-check guaranteed.

Weighing feasibility and costs

An important component in the comprehensive development and planning of the product is to balance feasibility and implementation costs. To this end, we present our clients a decision matrix with several realization routes that represent the best possible options within the budget. In this way we ensure that our customers always receive the best individual solution according to their budget plan.

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At the same time our experts make sure that all components are state-of-the-art. It is also made certain that each individual part is available for a long time at our suppliers. In this way, we not only produce high-quality products, but can also secure that they can be manufactured and supplied in continuity.

Production engineering

Connecting idea and realization

The production engineering department is the decisive interface between the product idea and its realization. Accordingly, the production engineering department links development (systems engineering) and production. As the production engineering department provides all specifications for the creation of the production line, which is then subject to strict validation controls, it is also the direct contact for production.

Lean efficiency for individual projects

Efficiency all along the line. This is what the production engineering department creates. This is where customer-specific product requirements are transformed into a dynamic, lean optimized process ready for production. After all, each individual customer request requires a corresponding implementation of the production technology within the production line.
With our competence and experience, we ensure that the specifications are always met and the quality is always first class.

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The extensive range of tasks and services is furthermore divided into two areas: mechanics and test engineering. Both fulfill essential tasks in their areas, which include the following:

Tasks:

  • Preparation of the documentation of manufacturing processes.
  • Preparation and implementation of working procedures.
  • Preparation and implementation of changes in the manufacturing process.
  • Testing and tendering of new production line equipment.
  • Preparation and implementation of manufacturing improvements using lean principles.
  • Project management and direct customer contact.
  • Develops software/firmware programs according to the defined product requirements.
  • Ensures proper installation and equipment for development and production of a specific project.
  • Creates product and project documentation.

Production

Producing next-generation diagnostic devices

We produce customized, specification-accurate, miniaturized and highly integrated machines that set standards in terms of quality, reliable precision and compact design. These products are either developed by LRE and consecutively manufactured at LRE or externally developed and transferred to LRE manufacturing. In both cases our claim to the highest customer satisfaction is always the guide to our efforts.

Our holistic value chain begins extremely early and is very detailed with the combined specifications of quality assurance, systems development and product engineering. Alongside this extends our enormous vertical range of production, which stretches from the printed circuit boards to the assembly of the finished, 100% tested – all validated meeting customers’ quality requirements and supporting customers’ regulatory filing.

Individual, yet highly efficient

Our overall efficiency, even with enormously individual, tailor-made products, is achieved through our lean-optimized production area. The workflow is precisely specified by the production engineering group. Our well trained skilled employees watch every stage of production in terms of quality, precision and exactness of the product.

Furthermore, our workplaces are arranged according to the EH+S standard for environment, health and safety, so that we can provide security of our employees at all times during production.

Experts ats LRE Medical Nördlingen manufacturing diagnostic instruments

Quality Assurance
and regulatory compliance

Helping customers to bring compliant products to the market

LRE’s well established Quality Management System for Medical Devices, based on ISO 13485:2016 in alignment with 21 CFR 800 series and experience with relevant accreditations give our customers a firm regulatory framework for product development and manufacturing.

Supported by proven close relationships with authorities, Notified Bodies and test houses for safety we provide the framework to our customers for obtaining european and/or worldwide market approvals for their medical devices in line with directives and regulations like MDD and IVDD for CE approval in Europe as well as for product release by FDA’s or relevant authorities around the world.

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In times of changing regulations with the newly coming European MDR and IVDR we actively supports our customers over the next years by transitioning existing devices and as well developing new products in line with these new regulations.

Quality is everything

Quality assurance at LRE spans across all departments involved in product development and production. All activities mirror the fulfillment of quality requirements needed for safe, effective and innovative products for diagnostics, life sciences/analytics and medtech.

TO THE TOP

Supply and Logistics

Supplying continuity and reliability

Our purchasing and logistics department is the hub for all ordering, import and export activities at LRE. This includes purchasing of required components, complete order processing and handling, customs and authority matters, goods storage and storage management. The smooth handling of these various and complex services is at our highest priority.

Delivering excellence

On the grounds of our company’s philosophy LRE established a skills matrix which allows other colleagues replacing immediately any personnel lacks. Thus, an absolute reliable handling within our logistic department is guaranteed; for our customers, this includes a fast, dynamic reaction speed, process and deadline reliability as well as supply chain security.

Close cooperations, in-house and all over the globe

Seamless collaboration of purchasing/logistics and systems engineering is mandatory. After determining necessary components by system engineering, LRE purchasing handles independently and compares offers with long-term supply partners via our worldwide sourcing system. Our final goal is: The right material, with the right quality at the right time.

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Since we always prefer long-term partnerships to ensure supply and production continuity, the selected suppliers
must also be able to cope with volatility, while being able to guarantee consistent quality.

Thanks to the close cooperation with our production department, the finished products have been shipped by the logistics department
promptly. Our purchasing and logistics department is virtually an internal service provider to all LRE divisions, delivering components to the lock of production lines and taking the finished production to distribution.

TO THE TOP

Service

Complete service for each single product

Our service, or more precisely after sales service, is completely customer-centered – beginning with the service agreement, which is individually coordinated to the wishes and needs of our customer, before production.

Our department is set up in a way that it can react quickly and reliably to any request or issue. We are constantly in a close dialogue with our customers and can respond to any inquiries regarding refurbishments and basic updates quickly and reliably. This way we  keep the devices and their performance up-to-date.

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Usually, the instrument is sent to the LRE facility, a thorough analysis, repair or update is performed and afterwards returned to the customer. Alternatively, we enable our customers by intensive training of their technicians to perform the service on their product themselves. All necessary tools, software, hardware and consulting support will be provided by LRE, completely tailored to our customers’ needs.

Continuous optimization

With our After Sales Service approach based on consequent product support, identification of improvement potential up to input for next generation products we want to secure highest levels of customer satisfaction.

Certificates

Maintaining high quality standards is crucial for your line of work?
That also applies to us. You’d like to know which internationally recognized certificates we obtained and constantly renew?

EN ISO 13485
standard for Medical devices

LRE is certified according to ISO 13485:2016 and holds the corresponding certificate.

Manufacturing of diagnostic instruments at LRE Medical Nördlingen