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Goal-Oriented Cycle Services
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.