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At FINI Instruments, quality, safety, and strict regulatory adherence form the bedrock of our manufacturing processes. Operating from Sialkot, Pakistan, we provide healthcare networks, OEM distributors, and hospital procurement partners with fully traceable, ISO-certified, and compliant surgical, dental, and electrosurgical instruments.
FINI Instruments operates under an ISO 13485:2016 and ISO 9001:2015 certified quality management system. All reusable medical, surgical, and electrosurgical devices comply with EU MDR 2017/745 specifications. Official Certificates of Conformity, QMS manuals, risk assessments, and technical dossiers are available for immediate download or audit review upon request.
Explore our active ISO certifications and European regulatory compliance records below:
Comprehensive medical device quality management system certification covering design, forging, and manufacturing.
Validates continuous quality control management across initial design, raw material sourcing, forging, and finishing stages.
Meets European Union Medical Device Regulation (EU MDR 2017/745) health and safety requirements for export across Europe.
| Document / System Description | Compliance Status | Action |
|---|---|---|
| ISO 13485:2016 Certified Quality System | Available | View File |
| EU MDR (2017/745) Technical Documentation | Available | View File |
| Quality Management System (QMS) Manual | Available | View File |
| Risk Management Procedure (ISO 14971) | Available | View File |
| Sterilization Validation Reports (Autoclave Standards) | Available (Upon Request) | Request PDF |
FINI Instruments manufactures reusable surgical, dental, and electrosurgical hand instruments in strict compliance with applicable global health regulations. We maintain structured technical dossiers to support international procurement networks, OEM contracts, and hospital tender applications.
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