Delivering Precision
and Quality Beyond Compliance

Our commitment to exceptional quality ensures every product meets the highest global standards, enhancing lives worldwide.

Our stringent controls ensure precision, safety, and trust in every product
• Quality is at the heart of everything we do at Envision Scientific.From raw materials to final product manufacturing, every stage is governed by rigorous quality protocols.
• Our proprietary Integrated Concept Management System (ICMS) surpasses traditional quality management systems.
• We ensure compliance with international standards while driving continuous improvement.
• Commitment to quality spans 60+ global markets, including the USA, Japan, and Europe.We not only meet regulatory requirements but set new benchmarks in precision and safety.
• Every product represents our dedication to innovation, patient safety, and global healthcare excellence.

Our proprietary ICMS goes beyond traditional QMS to integrate innovation, risk management, and continuous improvement.

Envision Scientific’s Integrated Concept Management System (ICMS) redefines quality in medical device manufacturing. It integrates

Risk-based Controls: Proactively identifies and mitigates risks across all processes.

‍Real-time Monitoring: Ensures immediate resolution of quality deviations.

‍Continuous Improvement: Harnesses feedback loops for innovation and efficiency.

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Quality control begins with meticulous raw material testing.

100% quality control policy — only materials meeting stringent specifications proceed to production.

Testing conducted in ISO/IEC-17025 certified laboratories.

Uses 21 CFR Part 11 compliant high-precision instruments (HPLC, GC, LPC systems).

Key testing processes:

Microscopic Analysis

Ensures surface integrity and
defect-free raw materials.

Microbiology Testing

Confirms product sterility and bacterial endotoxin (BET) levels.

Finished Product Analysis

Drug content uniformity, drug release profile, drug purity, particulate matter, residual gas, and solvent testing.

Envision Scientific operates specialized labs for critical quality assessment:

Microbiology Labs

Sterility, bacterial endotoxin (BET), and bioburden testing ensure safety.

HPLC & GC Labs

Chromatographic analysis validates product potency, purity, and stability.

Particulate Matter Labs

Particle count testing confirms device integrity

Wet Labs

Performance testing conforms device safety

Our state-of-the-art laboratories ensure every product meets global regulatory standards with precision testing.

Additional highlights

Facilities include 7 stability chambers.
Chambers simulate real-world environmental conditions.
All chambers and instruments are connected to 21 CFR Part 11-compliant systems for real-time monitoring.

Certified for trust: Our facility meets the most rigorous global standards for medical device manufacturing.

Envision Scientific is ISO-certified and compliant with:

• US FDAPMDA (Japan)
• ANVISA (Brazil)
• EU MDRCDSCO (India)

Certified systems include:
• ISO 14001 (Environmental management system)
• ISO 45001 (Occupational health and safety management)
• ISO 41001 (Facility management)
• ISO 22301 (Business continuity management)
• ISO 27001 (Data security)

Regulatory approvals in 60+ countries.

PMS activities include:
• Continuous collection and analysis of clinical data
• Long-term stability studies to validate shelf life and performance
• Responsive feedback loops for real-time improvements

Tools used:
• Failure Mode and Effects Analysis (FMEA)
̐ • Corrective and Preventive Actions (CAPA)

Our Post-Market Surveillance (PMS) ensures product safety and performance after market release.

Empowering our team to maintain the highest quality standards through continuous training.

Every team member undergoes rigorous role-specific training programs.Training covers advanced instruments, ICMS protocols, and regulatory compliance.Regular assessments and feedback ensure continuous skill enhancement.

Delivering Excellence in Quality Control
with Industry-Leading Technology.

At our facility, we are committed to maintaining the highest standards of quality. Our quality control department is equipped with
state-of-the-art machines such as the Cooling Cabinet Chamber, LASER Micrometer, HPLC System, Stability Chamber, and GC-FID
with ALS/HeadSpace Sampler. Each piece of equipment/Instrument is selected from trusted, globally recognized manufacturers
to ensure precise, reliable, and efficient testing processes.