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    Our Core Services

    CDSCO Regulatory Consultancy

    End-to-end support for medical device registration, import license, and manufacturing license as per CDSCO guidelines.

    ISO 13485 Certification

    Complete implementation and certification support for medical device quality management systems.

    ISO 9001 Certification

    Establish efficient quality management systems to improve performance and customer satisfaction.

    BIS Certification

    Support for BIS approval including product testing, documentation, and certification process.

    ZED Certification (MSME)

    Enhance manufacturing quality and sustainability through ZED certification.

    Technical Documentation & DMF Preparation

    Preparation of Device Master File, STED, and regulatory documentation.

    Internal Audit & Training

    We conduct professional audits and training programs to ensure compliance and readiness for certification.

     

    Regulatory Strategy & Compliance Support

    We provide strategic consulting to help businesses plan regulatory pathways and market entry.

     

    View All Services
    ESTABLISHED IN 2024

    Expert Regulatory & Quality Consulting for MedTech

    Avinash MedTech Solution is a specialized consultancy dedicated to supporting medical device manufacturers and healthcare companies. Founded by Avinash Sharma, a certified Lead Auditor for ISO 13485, we bring deep expertise in Quality Management Systems (QMS) and CDSCO frameworks.

    Our goal is to simplify complex regulatory pathways and enable businesses to bring safe, compliant, and high-quality medical products to market efficiently. With a practical, client-focused approach, we help you build sustainable compliance systems that last.

    READ MORE
    Delivering structured and result-oriented regulatory solutions

    How We Work

    01.

    Requirement Analysis

    We understand your product, business model, and regulatory requirements to define the correct compliance pathway.

    02.

    Documentation & Planning

    Preparation of complete technical documents, quality manuals, and regulatory files as per CDSCO and ISO standards.

    03.

    Submission & Compliance

    We handle application submission, authority coordination, and ensure full compliance with regulatory guidelines.

    04.

    Approval & Certification

    End-to-end support until successful approval, certification, and audit completion.

    FOR YOUR REGULATORY NEEDS

    We Provide Expert Compliance Services

    We provide end-to-end regulatory and quality consultancy for medical device manufacturers, importers, and healthcare companies. Our expertise ensures smooth approvals, accurate documentation, and full compliance with national and international standards.

    Services for Manufacturers:

    • CDSCO Medical Device Registration
    • ISO 13485 Implementation
    • ISO 14971 Risk Management
    • Technical Documentation (DMF/STED)
    • Internal Audits & Training

    Services for Importers & Businesses:

    • Import License (CDSCO)
    • CE Marking Consultancy
    • ISO 9001 Certification
    • BIS Certification
    • ZED Certification (MSME)
    learn more
    FOR YOUR REGULATORY SUCCESS

    How We Work with Clients

    Preparation of a package of documents

    Meeting with a lawyer, signing a contract

    Terms of payment for the performance of work

    Why Choose Avinash MedTech Solution?

    We are committed to delivering reliable, efficient, and result-oriented regulatory and quality consultancy services. Our expertise helps businesses achieve compliance smoothly and bring safe medical devices to market with confidence.

    Reliability

    We provide dependable consultancy with complete transparency, ensuring smooth regulatory approvals and long-term compliance support.

    Quality Expertise

    Our services are aligned with international standards like ISO 13485, ISO 9001, and ISO 14971, ensuring high-quality compliance systems.

    Result-Oriented Approach

    We focus on faster approvals, accurate documentation, and successful certifications to help your business grow efficiently.

    Still have questions about CDSCO or ISO?

    Leave your number, and our lead auditor will call you to discuss your regulatory needs.

      ESTABLISHED IN 2024

      Expert Regulatory & Quality Consulting for MedTech

      Avinash MedTech Solution is a specialized consultancy dedicated to supporting medical device manufacturers and healthcare companies. Founded by Avinash Sharma, a certified Lead Auditor for ISO 13485, we bring deep expertise in Quality Management Systems (QMS) and CDSCO frameworks.

      Our goal is to simplify complex regulatory pathways and enable businesses to bring safe, compliant, and high-quality medical products to market efficiently. With a practical, client-focused approach, we help you build sustainable compliance systems that last.

      READ MORE

      Customer Reviews

      They have already used our services

      Vikram Malhotra

      Avinash MedTech Solution provided exceptional support for our CDSCO Manufacturing License. Their deep understanding of the Medical Device Rules, 2017, and their meticulous approach to documentation saved us months of regulatory delays. Truly the best in the industry.

      Sanjay Kapoor

      Achieving ISO 13485 certification seemed like a daunting task until we partnered with Avinash Sharma. His expertise as a Lead Auditor was evident in every step, from the initial gap analysis to final audit readiness. We now have a robust quality system in place.

      Dr. Anjali Verma

      he team at Avinash MedTech Solution is professional, transparent, and highly efficient. They handled our CE Marking and BIS certifications with total precision. Their strategic guidance on product classification was instrumental in our successful market entry.

        A Guarantee of Achieving the Desired Result!

        The specialists of our company will provide you with expert advice on any issue that interests you.

        • Experienced lawyers
        • Speed and reliability
        • An integrated approach

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