How do I request the EU MDR 2017/745 Declaration of Conformity for FINI Instruments?

You can request the official EU Declaration of Conformity (DoC), ISO 13485 certificates, or technical file indexes by emailing our regulatory compliance department directly at regulatory@finiinstruments.com.

Why is passivation critical to surgical instrument manufacturing?

Passivation is a chemical bath treatment that removes free surface iron and contaminants. This allows a protective chromium oxide layer to form, preventing corrosion, rust, and pitting during autoclave sterilization.

What is the advantage of laser annealing over deep engraving on surgical tools?

Laser annealing uses localized heat to create high-contrast dark markings without breaking the surface finish. This preserves the smooth chromium oxide layer, preventing bioburden accumulation and rust.

Quality Policy & Quality Management System (QMS)

Q: Can FINI Instruments provide UDI barcoding on packaging?

Yes. We support standard linear barcodes and 2D DataMatrix codes for Unique Device Identification (UDI) in full compliance with US FDA GUDID and EU MDR 2017/745 requirements.

ISO 13485:2016 Certified

Precision Engineering & Global Compliance

At FINI Instruments, we balance precision craft with strict international quality management systems. Our surgical, dental, ophthalmic, and veterinary instruments are forged from premium medical-grade stainless steel to deliver uncompromised safety and durability.

100%

Quality Inspection

Class I & Ir

EU MDR Compliant

Global Certifications & Standards

Certified

ISO 13485:2016

Audited QMS specific to medical device manufacturing and risk management.

Certified

ISO 9001:2015

International standard for consistent operational quality and continuous improvement.

Registered

US FDA Compliant

Fully compliant with 21 CFR Part 820 Quality System Regulations (QSR).

EEA Ready

EU MDR 2017/745

Complete CE marking pathways for Class I and Class Ir reusable instruments.

EU MDR 2017/745 Class I & Class Ir Dossiers

We maintain structured Technical Documentation under Annex II & Annex III, complete with GSPRs, ISO 14971 Risk Management, ISO 17664 Validated Reprocessing Guidelines, and UDI DataMatrix laser marking.

✓ Declaration of Conformity (DoC)
✓ EUDAMED Ready
✓ Technical Files Index

Request Regulatory Dossiers

Our 11-Step Quality Management Workflow

Step 01

Material Verification (PQA)

Spectro-analysis & chemical composition testing of incoming AISI stainless steel batches.

Step 02

Hot & Cold Drop Forging

Precision drop hammers refine grain density followed by stress-relieving annealing.

Step 03

Precision Machining

Multi-axis CNC milling, drilling, and turning form precise box joints, ratchets, and teeth.

Step 04

Manual Joint Alignment

Master craftsmen assemble joints and hand-file jaw serrations and ratchet lock points.

Step 05

Vacuum Heat Treatment

Computerized tempering establishes HRC hardness (45–50 HRC Forceps | 50–55 HRC Scissors).

Step 06

Riveting & Welding

Hand-riveting for smooth pivot action and micro-laser welding for complex multi-part tools.

Step 07

Grinding & Polishing

Finishing in anti-glare Satin/Matte, high-lustre Mirror, or electropolished finishes.

Step 08

Chemical Passivation

Strips free iron to form a protective chromium oxide layer that prevents autoclave corrosion.

Step 09

Ultrasonic Cleaning

Multi-stage ultrasonic tanks strip all remaining oils, compounds, and micro-particles.

Step 10

Final QA & Laser Marking

100% QA dimensional inspection followed by high-contrast fiber laser annealing for branding.

Step 11

Protective Packaging & UDI Barcoding

Sealed in moisture-controlled polybags or blisters with GS1-compliant UDI DataMatrix codes ready for global distribution.

Quality & Compliance FAQ

You can request our official EU Declaration of Conformity (DoC), ISO 13485 certificates, or technical file indexes directly by emailing our regulatory department at regulatory@finiinstruments.com.

Passivation is a post-polishing chemical bath treatment that removes free surface iron particles introduced during machining. This allows a continuous protective chromium oxide layer to form, which prevents rust, pitting, and corrosion during repeated autoclave cycles.

Laser annealing uses localized heat to create high-contrast dark markings beneath the surface without penetrating or breaking the stainless steel finish. This preserves the smooth chromium oxide layer, preventing bioburden accumulation and surface rusting during sterilization.

Yes. We specialize in custom OEM packaging and label generation. We support standard linear barcodes and 2D DataMatrix codes for Unique Device Identification (UDI) in full compliance with US FDA GUDID and EU MDR 2017/745 requirements.

Partner with FINI Instruments

Discuss custom OEM/ODM manufacturing, request technical audits, or order compliance documentation.

Contact Regulatory & Sales Team