LRE Medical GmbH, founded in 1961, is part of the Esterline Technologies Group. It is an award-winning full-service contract provider with creative ideas, expert market knowledge and 50+ years of experience in design, development and manufacturing of precision instrumentation (laboratory, molecular diagnostics, point-of-care, handheld) around existing and innovative technologies.
LRE Medical provides its OEM customers with full turnkey projects 'one stop shopping' solutions involving a complete bouquet of services (contract engineering, contract manufacturing, after sales service and lifetime product support) for converting their ideas into both innovative and commercially available devices targeted for use in the fields of medical and laboratory diagnostics, food, agriculture, and bio-detection markets.
LRE Medical successfully integrates its customers' assay 'know-how' with its instrumentation expertise. The company's product development and manufacturing groups continually look for ways to optimize product design and manufacturing processes that improve product quality, reliability and performance, reduce overall program and product costs, and shorten the time to market.
LRE has provided its customers with over 200 successful instrument development programs and millions of in vitro diagnostic (IVD) instruments that it has documented, manufactured, tested, and delivered - without a single recall. The company's instruments are competitively priced, high quality, and user-friendly. They range in sophistication from simple handheld single-test meters to sophisticated bench-top laboratory instrumentation with multiple technologies imbedded.
IVD Contract Product Design and Development
LRE's multi-disciplinary product development teams consist of experienced professionals with commitment, expertise, competence and excellent communication and interpersonal skills. They are focused on efficiently providing customers with innovative, reliable, superior performing, and highest quality instrumentation. This combined with their unique personal customer interactions results in an extraordinary development experience.
LRE's engineering development process for in vitro diagnostic instrumentation follows a defined phased process. As such, OEMs may engage LRE Medical for assistance at any point during a product's lifecycle (concept design and analysis to a fully manufactured and delivered product.) At the completion of each phase, jointly established milestones must meet or exceed the expectations of both LRE and its clients before a phase is considered complete.
Additionally, LRE Medical strongly believes in and practices 'concurrent engineering'. Developing the manufacturing process concurrently with product development significantly improves quality and reduces overall program and product cost.
LRE's core competencies encompass IVD instrumentation (contract development, contract manufacturing), optical measurement (reflectance, fluorescence, chemiluminescence), electrochemical measurement (amperometry, voltammetry, magnetic beads), PCR thermal cycling, liquid handling robotics and variable temperature control (specimens and reagents) with regards to IVD instrumentation utilizing strips, cuvettes, cassettes, microtiter plates, microchip or other assay technologies.
IVD Contract Manufacturing
From manufacturing process development to final packaging, LRE offers start-to-finish contract solutions customized to meet each of its customer's unique needs. LRE's product focused manufacturing work cells continuously deliver the highest quality products 'on-time' as demonstrated by the following statistics for 2013: on-time delivery was 100%, out-of-box failure was less than 0.14% for all instruments shipped, and no product recalls in 50+ years of manufacturing.
LRE is registered as well as fully certified, and routinely updates its rigorous design, development and quality manufacturing processes in compliance with ISO 14001, ISO 13485, and FDA CFR part 820 for class I through class III medical devices. Structuring and observing the processes and documentation required in these directives does not only mean conformance to legal requirements; it guarantees an efficient development and manufacturing process.
LRE's manufacturing capabilities encompass chip-on-board technology, printed circuit board (PCB) assembly, device assembly, testing and traceability (DMR/DHR), packaging, kitting, and order fullfillment, testing (in circuit - functional, AOI, AOX, component traceability system) and labelling, lean manufacturing environment with in-process controls, cost-effective and approved supply chain and logistics, scalable manufacturing volumes, large-scale prototype runs, work cell design, modelling, setup and validation, vendor audits and certification, manufacturing process validation, ongoing "DFX" activity post product release (cost, reliability, maintainability and manufacturability), and document / revision / product lifecycle management.
In addition to manufacturing, LRE Medical supports each product over its complete lifecycle. This includes: reverse logistics and repair and refurbishment of its manufactured products, returns management, exchanges, spare parts management and logistics, and continuous engineering support for obsolescence of parts, improved reliability and cost reductions.
LRE Medical continues to be extremely successful in a very competitive market. It is a strategically selected outsourcing partner that is keenly aware that the quality of its contract services and analytical devices contribute directly to the success of its OEM customers and their own successful operation.
Product and Business Development
LRE Medical GmbH / Esterline Corporation
Tel: +49 (0) 89-35 48 03-0
Fax: +49 (0) 89-35 48 03-67