Reliable Quality for Global Eye Care
SCIENCETERA develops ophthalmic medical devices under international quality and regulatory standards, supporting safe, reliable, and effective clinical performance.
Quality Management
SCIENCETERA is committed to developing ophthalmic refraction systems with consistent quality, safety, and clinical reliability.
Our products are developed and manufactured according to internationally recognized quality management and medical device regulatory standards.
Through continuous improvement, verification, risk management, and usability evaluation, SCIENCETERA strives to provide dependable solutions for global eye care professionals.
Development & Quality Process
SCIENCETERA applies systematic development and quality management procedures throughout the product lifecycle.
Planning
Requirements analysis, usability consideration, and clinical workflow evaluation.
Development
Hardware and software development with verification and validation activities.
Risk Management
Continuous risk analysis according to international medical device standards.
Compliance
Product testing, documentation, and regulatory conformity management.
Regulatory & Standards
SCIENCETERA products are developed with consideration for international medical device regulations and applicable standards.
MDR 2017/745
European Medical Device Regulation for medical device safety, performance, and post-market requirements.
EU MDRIEC 60601 Series
Medical electrical equipment safety and EMC standards including IEC 60601-1 and IEC 60601-1-2.
SAFETY & EMCIEC 62304
Medical device software lifecycle process for software development, verification, and maintenance.
SOFTWAREISO 14971
Medical device risk management standard applied throughout development and product maintenance.
RISK MANAGEMENTEngineering & Verification
SCIENCETERA continuously improves product quality, interoperability, usability, and system reliability through engineering-focused development.
Software Validation
Verification and validation activities are performed according to software lifecycle processes and intended device use.
Usability Engineering
User interface and workflow are continuously evaluated for safe and efficient operation.
Device Connectivity
SCIENCETERA continuously improves interoperability with third-party ophthalmic devices.
Compliance Documents
Download SCIENCETERA quality and regulatory information.
Certificate for management system
ISO 13485:2016 Medical Device Quality Management System
for Design, Development, Manufacturing and Sales of Ophthalmic Diagnostic Equipment
Declaration of Conformity
Visual Acuity Chart System TSLC-2000
Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 concerning Medical Devices.
EC Certificate
Auto Ref-keratometer TSRK-1000P
Directive 93/42/EEC on Medical Device (MDD), Annex V
Trusted Quality for Modern Eye Care
Contact SCIENCETERA for regulatory information, technical documentation, distributor support, or product inquiries.
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