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”.
While our portfolio includes the full range of surgical handheld instruments, we also supply special instruments for all areas of surgery.
The following disciplines: Orthopaedics, Traumatology and Spine Surgery – are our specialist fields. Due to the fact that we are located in the medical technology center of Tuttlingen, we can respond to special customer requests, especially where narrow manufacturing tolerances or small quantities are concerned. For the procurement of surgical instruments, we are glad to take over your Supply Chain Management.
Our customers recognize and appreciate our reliable delivery of the surgical instruments, the documented technical quality control and the technical know-how of our team. With our FDA registration as an OEM supplier, we serve the U.S. market and are active as a European Authorized Representative for American companies.
Please feel free to send us your inquiries – we impress with our customer-oriented, fast and reliable service for the delivery of surgical instruments manufactured in Tuttlingen.
- Implementation DIN EN ISO 13485 and the EU-Regulation 2017/745 MDR and 21 CFR 820 QSR
- Creating QM-Systems with procedural instructions and work instructions
- Technical Documentation
- Clinical evaluation
- Risk Manangement / Risk Analysis
- Essential Safety and Persormance Requirements
- Validation of processes
- UDI-labeling
- Consulting for Regulatory Affairs
- Internal audits and external supplier audits
- Accompaniment and support with inspections by authorities and Audits by notified bodies
- Communication with authorities
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.
Learn moreProcurement 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
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