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Certificates & Accreditations

Quality, Safety & Global Standards for  Amniotic Membrane Products, and Biologics, Medical Devices and Many More...

At Akriti Ophthalmic Pvt Ltd, every product — from advanced amniotic membrane technologies and biologics to Medical devices  — is built on uncompromising quality, safety, and ethical manufacturing. Our certifications reflect our commitment to global standards and patient‑centric innovation.

 Quality & Compliance Certifications

ISO Certifications

Akriti follows internationally recognized quality management systems that ensure precision and safety across all product categories, including:

  • Custom ocular prostheses
  • Amniotic membrane–based devices
  • Biologic implants and surgical adjuncts

Our ISO‑aligned systems ensure:

  • Controlled processing of biologic materials
  • Sterility assurance and validated workflows
  • Traceability and documentation
  • Continuous quality improvement

Regulatory Approvals & Licenses

CDSCO Compliance (India)

Akriti is a registered medical device manufacturer under the Central Drugs Standard Control Organization (CDSCO).
Our regulatory framework covers:

  • Amniotic membrane products (Amnio‑Patch™, Amnio‑Disc™, Amnio‑Ring™ )
  • Biologic surgical adjuncts (MacuSeal™ and related technologies)
  • Eye Sphere, Eye Conformers, Eye Shields 
  • Device Master Files (DMFs)
  • IFUs, MSDS, and safety documentation
  • Sterility and biocompatibility compliance

This ensures every product meets India’s highest standards for safety and performance.

US FDA Pathway Alignment

Akriti’s documentation and quality systems are structured to align with US FDA regulatory expectations, enabling future submissions and global market readiness.

FDA‑Aligned Components:

  • 21 CFR Part 820 (QSR): Quality system, CAPA, validation, supplier controls

  • 21 CFR Part 1271 (HCT/Ps): Donor screening, tissue processing, sterility

  • FDA‑style DMF/MAF preparation

  • UDI‑ready labeling & IFU compliance

Biologics & Amniotic Membrane Product Certifications

Akriti is one of India’s few medtech innovators with specialized certification pathways for biologic and amniotic membrane–based devices.

Our biologic product compliance includes:

✔ Tissue Processing Standards

  • Ethical sourcing and donor screening
  • Validated preservation and dehydration processes
  • Sterility assurance and microbial testing

✔ Quality & Safety Documentation

  • Batch‑wise traceability
  • Stability and shelf‑life validation
  • Packaging integrity testing

✔ Regulatory Alignment

  • SoHO (Substances of Human Origin) framework alignment
  • EU MDR classification mapping
  • HSN code mapping for global export readiness

These certifications ensure that Akriti’s amniotic membrane products are safe, reliable, and globally acceptable.

International Standards & Global Recognition

Akriti’s biologics and ocular prosthetic technologies align with global frameworks, enabling international distribution and regulatory acceptance:

  • EU MDR documentation alignment
  • FDA‑aligned quality documentation for future pathways
  • HSN code mapping for export
  • SoHO compliance for biologic materials

This positions Akriti as a global‑ready manufacturer of advanced ocular and biologic solutions.

Professional Certifications & Expertise

Board‑Certified Ocularist Leadership

Led by Prof. Dr. Kuldeep Raizada, India’s first Board Certified Ocularist, Akriti brings unmatched expertise in:

  • Amniotic membrane technologies
  • Biologic surgical adjuncts
  • Global medtech innovation

This leadership ensures that every product meets world‑class clinical and manufacturing standards.

✅ Training, Workshops & Skill Certifications

Akriti is a global training hub offering certified programs in:

  • Ocular prosthetics
  • Amniotic membrane applications
  • Biologic device handling
  • Anaplastology and medtech innovation

Participants receive internationally recognized certificates, reinforcing Akriti’s role in shaping the next generation of specialists.

✅ Why Our Certifications Matter

Our certifications represent a promise:

  • Safety in every biologic and prosthetic product
  • Precision in manufacturing and clinical outcomes
  • Ethical innovation in tissue‑based technologies
  • Global‑standard compliance for international partners

Every clinician, patient, and partner choosing Akriti receives products backed by the highest levels of quality assurance.

Certificates