Get certified. Stay compliant. Reach more markets.
The compliance side of Meditec: QM consulting and regulatory affairs for manufacturers of surgical instruments and implants.
PARTNERSHIP
QM Consulting & Certification
We support medical-technology companies in all aspects of certification according to DIN EN ISO 13485, MDR 2017 and MDD — drawing up every document needed for a notified body.
- New certification & re-certification
- Quality Manual, technical documentation, risk management
- Efficient, customer-specific documentation
CHALLENGES
Quality Management System
A sustainable QM system is the bottom line for manufacturers of surgical instruments and implants. We provide concise systems tailored to your company across development, procurement, manufacture and sales.
- ISO 13485 & MDR 2017/745 systems
- Individual solutions, not templates
- Maintained for certification or re-certification
CHALLENGES
Technical Documentation
Technical documentation plays an ever more important role in approval and certification. Our construction and QM experts keep pace with all current regulatory requirements.
- Design & technical files
- Verification & validation evidence
- Clinical evaluation support
PARTNERSHIP
QM Consulting & Certification
We support medical-technology companies in all aspects of certification according to DIN EN ISO 13485, MDR 2017 and MDD — drawing up every document needed for a notified body.
- New certification & re-certification
- Quality Manual, technical documentation, risk management
- Efficient, customer-specific documentation
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