Envision Scientific - A concept medical group company
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Delivering Precision and Quality Beyond Compliance

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

At Envision Scientific, quality is not just a process—it’s a culture of excellence. Our stringent controls ensure precision, safety, and trust in every product

Quality is at the heart of everything we do at Envision Scientific. From the moment raw materials enter our facility to the final product leaving our state-of-the-art manufacturing line, every stage is governed by rigorous quality protocols. Our proprietary Integrated Concept Management System (ICMS) surpasses traditional quality management systems, ensuring compliance with international standards while driving continuous improvement.

With a commitment to quality that spans 80+ global markets, including the USA, Japan, and Europe, we not only meet regulatory requirements but set new benchmarks in precision and safety. Every product we manufacture 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) is a proprietary framework designed to redefine 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

Our commitment to precision spans every stage, ensuring consistent excellence from raw materials to finished goods

At Envision Scientific, quality control begins with meticulous raw material testing and continues through multiple checkpoints during production. Our 100% quality control policy ensures that only materials meeting stringent specifications proceed to the next stage. Advanced testing processes are included.

Testing is conducted in ISO/IEC-certified laboratories, equipped with 21 CFR part 11 compliant high-precision instruments like HPLC, GC, and LPC systems.

  • Microscopic Analysis

    Microscopic Analysis
    Ensures surface integrity and defect-free raw materials

  • Microscopic Testing

    Microscopic Testing
    Confirms product sterility and bacterial endotoxin (BET) level

  • Finished Product Analysis

    Finished Product Analysis
    Validates drug contentuniformity, drug release profiles, drug purity, shade particle count , residual of gas and solvent

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

Envision Scientific operates specialized labs for each critical quality assessment

  • Microbiology Labs

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

    Microbiology Labs

  • HPLC & GC Labs

    Chemical (Chromatographical) analysis validates product efficacy (potency, purity, and drug stability)

    HPLC & GC Labs

  • Particulate Matter Labs

    Particle count testing confirms device integrity

    Particulate Matter Labs

  • Wet Labs

    Performance testing conforms device safety

    Wet Labs

Our facilities feature 7 stability chambers simulating real-world environmental conditions to ensure product efficacy over time. Each chamber and instrument is connected to 21 CFR Part 11-compliant systems for real-time monitoring and data accuracy.

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

Envision Scientific is ISO-certified and compliant with US FDA, PMDA, ANVISA EU MDR regulations and CDSCO. Our certifications span:

  • Environmental management system (ISO 14001)
  • Occupational health and safety management system (ISO 45001)
  • Facility Management (ISO 41001)
  • Business Continuity Management System (ISO 22301)
  • Data security (ISO 27001)

We have built a reputation for reliability, earning regulatory approvals in 80+ countries, including highly regulated markets. These certifications reinforce our commitment to delivering safe and effective products that exceed industry expectations.

ISO Certified

Our products are monitored for safety and performance, ensuring continuous improvement and patient trust

Our Post-Market Surveillance (PMS) ensures product safety and performance long after leaving our facility. Using tools like Failure Mode and Effects Analysis (FMEA) and Corrective and Preventive Actions (CAPA), we proactively address potential risks and maintain the highest safety standards. PMS includes:

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

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

Quality starts with our people. Every team member at Envision Scientific undergoes rigorous training programs tailored to their role. From induction sessions to specialized certifications, our training ensures:

  • Competency in handling advanced instruments and processes
  • Alignment with ICMS and global regulatory standards
  • Continuous skill development through regular assessments and feedback

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 is selected from trusted, globally recognized manufacturers to ensure precise, reliable, and efficient testing processes.