Certification of QM-Systems
Our customers, are manufacturers of surgical instruments, and for them we offer consulting in all areas of Quality Management Systems and Regulatory Affairs.
We draw up all documents necessary for certification according to DIN EN ISO 13485 and MDR. As a service-providing company for medical device manufacturers, our aim is to ensure that our customers reach their goals efficiently and with excellent support.
Development & Sourcing for Surgical Instruments
Our technical expertise is focused specifically on Orthopedic, Trauma and Spine Surgery. We are a first-rate partner for the procurement, development and manufacture of surgical instruments.
We can realize your projects both technically and logistically to the very highest standards.
Quality Management / Regulatory Affairs
Our role is that of an expert in implementing a QM system to fulfil the requirements for DIN EN ISO 13485 and the Medical Device Regulation 2017, in short MDR, for new certification or re-certification.
A sustainable Quality Management System is the bottom line for manufacturers of surgical instruments and implants. We can provide concise QM systems specifically tailored to the needs of your company.
Aufbereitungsvalidierung: Nachweis der maximalen Lebensdauer Ihres Medizinprodukts
Wie lange ist ein Medizinprodukt sicher einsetzbar? Als Medizinproduktehersteller müssen Sie diese Frage verlässlich und nachvollziehbar für Anwender und Patienten beantworten. Nach Normen und Verordnungen wie der MDR 2017/745 und der DIN EN ISO 17664 sind Sie angehalten, die maximale Lebensdauer Ihres wiederaufbereitbaren Produktes nachzuweisen und entsprechende Angaben in der Gebrauchsanweisung zu machen. Wir unterstützen Sie mit unserer hochspezialisierten Dienstleistung in diesem Prozess. Mit modernen Reinigungs- und Desinfektionsgeräten und Dampfsterilisatoren (Autoklaven) machen wir den Stress-Test für Ihre Instrumente. Wir validieren verlässlich die Einsatzdauer Ihres Medizinproduktes, simulieren eine Höchstzahl an Aufbereitungszyklen.
Development / Design / Project Management
As your partner for innovative development and project management, we develop surgical instruments and Implants including the required documentation.
Our experienced engineers support you with 2D and 3D CAD drawings or upon request design solid models in SolidWorks.
Purchasing / Sourcing / Procurement
We distribute surgical instruments which meet the very highest quality requirements.
In cooperation with the manufacturers in the medical technology center of Tuttlingen, we are an excellent source of surgical instruments with technical support worldwide. Supply chain management and supplier management are important elements of our core business.
Production
As an OEM-supplier we produce surgical handheld instruments in the medical technology center of Tuttlingen.
We are specialized in: Orthopedics, Traumatology and Spine Surgery.
Technical quality control
Take advantage of our measuring instruments and testing equipment for checking and documenting technical specifications for surgical instruments. The technical quality control is carried out by our qualified staff.
We guarantee compliance with the required tolerances and provide the required test certificates for documentation.
