Certifications & Standards
Every Equate instrument is manufactured under internationally recognized quality management systems. Our certifications ensure safety, precision, and regulatory compliance across global markets.
Explore Our Certifications
Click on any certification card to learn more about what it means for the quality and safety of your instruments.
ISO 13485:2016
Medical Device Quality Management
ISO 13485 is the internationally recognized standard for quality management systems specific to the medical device industry. It demonstrates our ability to design, develop, and manufacture medical devices that consistently meet customer and regulatory requirements.
Design & Development Controls
Every instrument undergoes documented design reviews, verification, and validation before production. Design inputs, outputs, and changes are traceable through our quality system.
Production & Process Controls
Manufacturing processes are validated, monitored, and controlled. Statistical process control ensures dimensional accuracy across production runs.
Traceability & Documentation
Complete batch traceability from raw material through finished product. Every instrument can be traced back to its source material, production date, and inspection records.
Post-Market Surveillance
Systematic monitoring of product performance in clinical use. Feedback loops ensure continuous improvement and rapid response to any quality signals.
CE Marking (MDR)
European Medical Device Regulation
The CE mark indicates that our instruments conform to the European Medical Device Regulation (EU 2017/745). It is a mandatory requirement for placing medical devices on the European market and signifies compliance with essential health and safety requirements.
Technical Documentation
Complete technical files maintained for every product family, including risk analysis, biocompatibility data, and clinical evaluation reports.
Biocompatibility Testing
Materials in direct or indirect patient contact are evaluated per ISO 10993 for cytotoxicity, sensitization, and irritation — ensuring safe clinical use.
Manufacturing Compliance
Production facilities and processes are assessed against Annex VIII requirements. Regular audits ensure ongoing conformity with the MDR.
Post-Market Vigilance
Active vigilance system for monitoring adverse events and field safety corrective actions in accordance with MDR Article 87-92.
FDA Registration
US Food & Drug Administration
Our manufacturing facility is registered with the US Food and Drug Administration. Our dental instruments are listed as Class I medical devices, subject to FDA's Quality System Regulation (21 CFR Part 820) and Good Manufacturing Practice requirements.
Facility Registration
Our production facility is registered with the FDA and subject to inspection. Annual registration renewal ensures continued compliance.
Device Listing
All orthodontic instrument product families are listed in the FDA's device database with appropriate product codes and classification.
Quality System Regulation
Manufacturing processes comply with 21 CFR Part 820 — covering design controls, production processes, corrective actions, and management responsibility.
Adverse Event Reporting
MDR (Medical Device Reporting) procedures are in place for timely reporting of any adverse events to the FDA as required by 21 CFR Part 803.
ISO 9001:2015
Quality Management System
ISO 9001 is the world's most widely recognized quality management standard. It provides a framework for consistent product quality, customer satisfaction, and continual improvement. Combined with ISO 13485, it reinforces our commitment to excellence across all operations.
Process Approach
All business processes — from procurement to delivery — are mapped, measured, and optimized. Key performance indicators drive continuous improvement.
Customer Focus
Customer requirements are systematically captured, communicated across the organization, and verified in the finished product. Satisfaction is monitored and acted upon.
Risk-Based Thinking
Proactive identification and mitigation of risks throughout the product lifecycle. Opportunities for improvement are systematically captured and evaluated.
Continual Improvement
Regular management reviews, internal audits, and corrective actions drive an ongoing cycle of improvement in product quality and process efficiency.
Quality at Every Step
Every instrument passes through five rigorous stages of production and quality control before reaching your hands.
01
01
Material Selection
Premium-grade stainless steel sourced from certified suppliers with material certificates and batch traceability.
02
02
Precision Manufacturing
CNC machining, forging, and hand-finishing under validated production processes with in-process quality checks.
03
03
Multi-Point Inspection
Shape test, boil test, and performance test on every instrument. Dimensional verification against engineering specifications.
04
04
Passivation & Cleaning
Chromium oxide passivation for corrosion resistance. Ultrasonic cleaning removes all manufacturing residues.
05
05
Final QC & Packaging
Individual inspection, QC approval, and individually packed instruments ready for sterilization at point of use.
