Since 2021, the Medical Device Regulation 2017/745 have been in place in the EU. Among other things, the term “medical device” is now more broadly defined. For example, the charger of a hearing aid now falls under the regulation and must be produced under correspondingly strict criteria.
Lercher met these challenging, yet exciting, new requirements by establishing its own production unit.
Lercher Medical is a subsidiary company of Lercher Werkzeugbau and specializes exclusively in the production of cutting-edgemedical technology.
We will make your product idea a reality.
We have decades of experience in the production of precision plastic parts, and our involvement starts long before your idea is poured into a finished product. We will support you from the start! For instance, we can help make your product suitable for injection moulding with our extensive range of services, including:
- Tool design
- Form and tolerance analyses
- FEM calculation
- Injection moulding simulation
- Filling simulation
- Creation of tool concepts
- Construction of packaging systems (in collaboration with qualified service providers).
The mould makes the product. Vertical integration, precision, and accelerated processes.
Our vertical integration in toolmaking is what sets us apart. It is unique for a plastic injection moulding supplier to have its own tool shop equipped with such vast technological capabilities. To ensure the highest quality and efficiency, we design and manufacture our tools in-house with:
- A highly qualified team
- Precise production on the microscale
- Stat-of-the-art technology (5-axis CNC milling, turn milling, HSC milling, grinding, wire and sink EDM, etc.)
- Tools designed and built specifically for customer requirements.
Different tools for different requirements.
- Stack tools for multi-component parts made of different materials
- Multi-component tools (for large quantities)
- Cleanroom tools (for parts produced in cleanrooms)
- Over-moulding tools (plastic isinjected around an existing part – e.g. injecting plastic around a metal core)
- Die casting tools (aluminium,zinc) for die-cast parts made of various materials
- PIM tools for injection moulding of metal powders, ceramics, and polymers
- RPT tools for the production of parts needing rapid prototyping
Servicing, maintenance, and tool storage.
All tools undergo regular servicing and revisions in-house within our assembly department. They are stored in our modern, robot-operated high-bay warehouse and can be quickly made ready for use.
Markets don’t sleep and neither do we.
Our production operates in a 3-shift system, operating around the clock, 24/7. An armada of more than 40 plastic injection moulding machines, with clamping force of 60 to 500 tonnes, is tirelessly in use. Parts handling, including loading and unloading, is largely automated and/or preformed robotically. This enables us to achieve an output of over one billion precision parts per year, maintaining consistent quality from the first to the last piece.
Production from a glance:
- Processing of all common thermoplastics (TPU, TPE, PEEK, Polyethylene, PE, PP ESD, and plastics with up to 60% glass fibre percentage)
- Shooting capacity of up to 1,700 cm3
- More than 40 plastic injection moulding machines with a clamping force of 60 to 500 tonnes
- Production in class 8 clean rooms
We continue where others stop. We ensure completion.
Our services extend beyond plastic injection moulding. We offer parts assembly from small to large-scale series in our class 8 cleanroom. Additionally, we perform downstream production stages such as joining, welding, or UDI-compliant labeling. These processes are carried out manually, partially, or fully automatically, with consideration for economic efficiency. Furthermore, we offer parts packaging and can provide sterilization upon request.
- Component assemblies in class 8 cleanroom
- Packaging solutions (bulk and individual packaging, packaging in sterile barrier systems right up to final packed product)
- Sterilization, including appropriate sterilization validation (ethylene oxide sterilization and gamma ray sterilization)
- Lean, efficient supply chain through our in-house services
Certified competence: We excel in what we do, and we do what we excel in.
All processes in our company comply with ISO 13485:2016. Validated processes and a monitoring system for all relevant product and process variables guarantees consistent quality and complete traceability throughout the entire process chain.
- Validated processes and monitoring system
- Risk management
- Initial sample test reports (EMPD, IQ, OQ)
- In-series examination
- Latest measurement technology (with 3D measuring machine)
- Precision and quality without compromise
Your problems can be the start of our partnership.
Many of out long-standing customer relationships began with an acute problem we were able to solve thanks to our 45 years of experience and our vertical integration in toolmaking and plastic injection moulding. For example, when developing a tool not every partner is aware of the complex requirements that the subsequent series production requires. At Lercher, construction and mass production are separated by exactly one door. The efficient organization of our company makes problems visible and solutions achievable before straining time and budgets.
- Review and (if necessary) optimise existing customer tools
- Detailed exchange ofinformation on upcoming issues
- Jointly identify, analyse, and document your requirements and the resulting production challenges
- Quick decisions on possible solutions
- Facilitate knowledge transfer of production to your project team
Contact
Lercher Medical GmbH
Treietstraße 1
6833 Klaus
Austria
T +43 5523 62417 0
F +43 5523 62417 4
info@lercher-medical.at
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