Accreditation Services

CDSCO Notified Body Approval

Achieve CDSCO Notified Body Approval with Expert Guidance

At Alpine Quality Consultants, we specialize in assisting certification bodies in obtaining CDSCO Notified Body approval, ensuring compliance with the Central Drugs Standard Control Organization (CDSCO) regulations for Medical Devices and In-Vitro Diagnostics (IVDs). Our expert consultancy services help organizations navigate the approval process, ensuring compliance, efficiency, and credibility.

What is CDSCO Notified Body Approval?

CDSCO Notified Body Approval is required for organizations that assess and certify medical devices and IVDs under the Medical Devices Rules, 2017 in India. A CDSCO-approved Notified Body is authorized to conduct audits, verify compliance, and certify medical devices for manufacturers seeking regulatory approval. This accreditation enhances trust, ensures regulatory compliance, and facilitates market access for medical device companies.

Our Consultancy Services

We provide a structured, end-to-end approach to obtaining CDSCO Notified Body Approval, including:

Regulatory Readiness & Gap Analysis

  • Comprehensive evaluation of your certification body's current processes
  • Identification of gaps against CDSCO Notified Body requirements
  • Strategic action plan for achieving compliance

Documentation & Process Implementation

  • Development of Quality Manuals, SOPs, and regulatory documentation
  • Assistance in developing auditing, certification, and assessment procedures
  • Guidance on competence, impartiality, and risk management requirements

Auditor Training & Competency Development

  • Training sessions on CDSCO regulations, Indian medical device requirements, and assessment criteria
  • Workshops on conducting audits, evaluation techniques, and certification processes
  • Coaching for personnel on Notified Body responsibilities and compliance expectations

Internal Audits & Pre-Approval Preparation

  • Conducting internal audits to assess compliance effectiveness
  • Pre-approval audits to ensure readiness for CDSCO assessment
  • Corrective action planning and risk mitigation strategies

Approval & Post-Approval Support

  • Assistance with the CDSCO application and documentation submission
  • Support during the CDSCO audit and approval process
  • Ongoing maintenance and continuous improvement of Notified Body operations
Alpine Quality Consultants

Your Trusted Partner in Medical Devices & IVDs Technical Consultancy

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