Missing an instrument? We make it happen.
From a first sketch to a certified, market-ready surgical instrument — Meditec Source is your single partner for development, sourcing, OEM production and regulatory approval. Made in Tuttlingen.
How we help
What can Meditec solve for you?
Most clients come to us with one of these challenges. Whichever yours is, we cover it end-to-end.
Development, design and project management
The successful development and managing of projects for surgical instruments/sets is our passion. With our experience in medical technology we provide customized and rapid product solutions for our clients.
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Procurement and supply chain management
Meditec Source, as an OEM supplier in the field of medical technology, provides many renowned clients worldwide with surgical instruments “Made in Tuttlingen”.
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Manufacturing and production
We produce surgical instruments in line with your specifications in close co-operation with our partners in the medical technology center of Tuttlingen.
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Technical quality control
Our technical quality control, in which all specifications, tolerances and surface labeling are checked, recorded and documented, ensures that only flawless products leave our company.
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Quality management consulting and certifications
Our experienced team acts as consultants for companies who are manufacturers of medical devices /surgical instruments. We provide Quality-Management-Systems for meeting legal and normative requirements.
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Quality management systems
For certification according to DIN EN ISO 13485 and the Medical Device Regulation MDR 2017/745 it is necessary to create a Quality Management System.
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Technical documentation
We prepare the necessary technical documentation for the approval of your surgical instruments in the classes I (including Is, Im, and new for MDR class Ir), IIa, and IIb, according MDR 2017/745.
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Validation Services
Reprocessing Validation: Proof of the Maximum Lifecycle of your Medical Device
Learn moreTwo business units, one partner
Everything from the workshop and the paperwork
Meditec is built around two complementary units — the rare combination of metal craft and regulatory rigour.
Sourcing & Manufacturing
The hands-on side: we develop, source, produce and inspect surgical instruments “Made in Tuttlingen”.
Quality management and regulatory
The compliance side: we get your devices certified and keep them compliant across the EU and US.
Quality & Compliance
Certified for the world’s most demanding markets
We work to the standards medical device manufacturers depend on — in both the EU and the United States.
ISO 13485:2016
Medical device QMS
FDA 21 CFR 820
US quality system
MDR 2017/745
EU Medical Device Reg.
MDD
Legacy directive support
FDA Registered
OEM supplier, US market
EU Auth. Rep.
For US manufacturers
TESTIMONIALS
Known and trusted throughout the
medical industry
Meditec felt less like a supplier and more like an extension of our own engineering team. They understood the regulatory side as well as the metal — and that combination is rare.
Head of R&D
European orthopaedic OEM
Clinical focus
Specialist fields
Orthopaedics
Instruments for joint and bone surgery, built to narrow tolerances and small-batch requirements.
Traumatology
Robust handheld instruments engineered for the demands of trauma and emergency procedures.
Spine Surgery
High-precision instruments for spinal procedures, backed by full technical documentation.
Proudly Part of the Kaleidex Group
Your preferred medical device contract manufacturing partner
Kaleidex’s mission is to become the first-choice manufacturing partner for medical device innovators, delivering seamless, high-quality, customised solutions. By uniting dynamic businesses, advancing manufacturing technologies and investing in skilled people, Kaleidex helps accelerate time-to-market and supports the development of life-enhancing medical technologies.
Our capabilities enhance the wider group
Quality Critical CNC Machining
from Oracle Precision Engineering
Oracle Precision is an advanced precision engineering company at the forefront of CNC machining techniques and manufacturing technology. Strategically based in the UK, Oracle Precision has become synonymous with the production of high-value, quality critical, yet affordable CNC machined components through state-of-the-art manufacturing and inspection process techniques with the best CNC milling machines.Precision Engineering Sectors.
Our capabilities enhance the wider group
Engineering the future of medtech.
Kirkstall Precision specialises in manufacturing complex components, prototypes, assemblies and production surgical instruments and implants for orthopaedic procedures, including joint reconstruction, spinal surgery, and trauma care. By combining deep industry expertise with advanced technology, Kirkstall supports customers to create products that meet the highest standards of safety and reliability.
Our capabilities enhance the wider group
Design, Development & Manufacturing of Medical Devices
OxDevice Medical is a precision engineering and manufacturing company based in Abingdon, Oxfordshire and provides a range of services to assist in the design and development of medical devices, manufacturing and associated testing. OxDevice is a specialist in developing devices for endovascular and neurovascular intervention, medical sensor development, clean-room manufacturing, medical electronics, nitinol devices and medical device coating services. OxDevice Medical is part of the Kaleidex Group.
Our capabilities enhance the wider group
Diamond ground, tungsten carbide jaw inserts for high quality surgical instruments
Serrations Ltd is a specialist manufacturer and leading producer of tungsten carbide inserts used in the production and repair of surgical instruments. The inserts are produced in Chesterfield, UK, and sold direct to manufacturers and repairers of surgical instruments globally. Serrations was founded in Sheffield in 1993 by Keith and James Hartley, and joined the Kaleidex group in January 2026, retaining the expertise of the Hartley family and their team.
Meditec Source News
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Tell us what you’re trying to build.
Whether you’re sourcing, developing, manufacturing or certifying — the Meditec team is ready to help.