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Documentation

Bhargava Consulting Group offers a comprehensive range of consulting services, with a specialist focus on quality management systems (QMS) documentation. Our experienced team of consultants will help you develop and implement efficient QMS systems that meet industry standards and empower your business with the tools necessary for success.

We help to design, assess, and implement Quality Management Systems that comply with FDA QSR/GMP, ISO standards, European Medical Device Directives, Canadian Medical Device regulations, and other medical device authorities' requirements.


Quality Management System Compliance:

We make sure through administrative and procedural activities implemented in a quality system that your medical device meets the specifications and requirements.


  1. Establishment and implementation of Quality Management Systems

  2. Issuing and maintaining the Quality Manual and Quality Procedures

  3. Establish MRB, CAPA, Training, Labeling, Document Control, and Internal Audit systems

  4. Clean Rooms, Sterilization, Packaging & Transportation validations

  5. Gap Analysis - assessment of your existing compliance with the current applicable requirements


Auditing:

Audits are executed to determine regulatory compliance and improve the effectiveness of your processes and those of your critical subcontractors and crucial suppliers


  1. Internal Audit - Essential to continuously improve your process and essential for full regulatory compliance.

  2. Subcontractor / Supplier Audit - Audits of critical subcontractors & crucial suppliers are vital to your Quality Management System

  3. CE Pre-Audit - With a CE Pre-Audit we guide you through the audit process before the Notified Body appears

  4. Unannounced Audit by Notified Body



Bhargava Consulting Group offers on-site support during regulatory audits or regulatory inspections.

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