Get certified. Stay compliant. Reach more markets.
The compliance side of Meditec: QM consulting and regulatory affairs for manufacturers of surgical instruments and implants.
“I NEED TO GET CERTIFIED”
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
“I NEED A WORKING QM SYSTEM”
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
“MY TECHNICAL FILE ISN’T READY”
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
“I MUST VALIDATE MY PROCESSES”
Validation of Processes
We validate the manufacturing and special processes behind your devices, producing the documented evidence regulators and notified bodies expect.
- Process validation protocols & reports
- Repeatable, documented outcomes
- Aligned to ISO 13485 / MDR
“HOW LONG IS MY REUSABLE DEVICE SAFE”
Reprocessing Validation
Under MDR 2017/745 and DIN EN ISO 17664 you must prove the maximum service life of a reusable device. We stress-test your instruments with modern cleaning, disinfection and steam-sterilisation equipment, simulating a maximum number of reprocessing cycles.
- Cleaning & disinfection device testing
- Steam steriliser (autoclave) cycling
- Evidence for your instructions-for-use
- Reliable service-life determination
Facing a certification or audit deadline?
The sooner we’re involved, the smoother the route to market.
Let’s talk timelines.