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.
Meditec Source provides reliable and customer-specific documentation to support medical device manufacturers in fulfilling regulatory requirements.
Regulations that are constantly changing require professional support. We provide individual solutions in the fields of development, procurement, manufacture and sales. We draw up all QM documentation for Certification or Re-certification through a notified body according to customer needs.
- ISO 13485 & MDR 2017/745 systems
- Individual solutions, not templates
- Maintained for certification or re-certification
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.
Learn moreQuality 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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