ISO 13485 Certification

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ISO 13485 Certification

The medical device industry is littered with a complex array of regulative systems, national and international standards and alternative needs. ISO 13485 standards are internationally recognized standard typically used for quality management system in medical devices industry in all across the world. Our company is topmost name in provider of ISO consulting Services and ISO 13485 Certifications in Ahmedabad and metro cities of Gujarat in India. ISO Consultant Ahmedabad is an auditing company that transformed ISO 13485 certification into an opportunity for customers to improve their company’s efficiency and thus increase growth of business and profits.

ISO 13485 Certificates play a vital role, especially when it comes to medical devices. As an ISO 13485:2003 Consultant we offer our services compliance with ISO 13485 not only improves company management but also assurance for safety and performance. However, its not essential that certification in Asian nation is valid in alternative markets like USA, North American country or Japan. Though ISO 13485 certifications is voluntary, getting certification permits to fulfill the standard system needs of the Medical Device Directive. Our company also offers ISO 13485 Training services for awareness above implementation, documentation of requirements and internal auditing process.

In order to successful implementation of ISO 13485 certifications, Organization require follow processes:

  • Document and record controls
  • Process and design controls
  • Risk management,
  • Environmental controls,
  • Internal auditing procedures
  • Special processes (e.g. software validation),
  • Corrective and preventative actions
  • Accountability and traceability
  • Record retention and traceability
  • Regulatory actions (such as vigilance)

Who Can Go For ISO 13485 Certification?

  • Companies who design, manufacture, distribute, install and repair medical devices for the european and World markets.
  • Companies who manufacture OEM products that are sold below different company names.
  • Companies who design and/or manufacture medical device parts or raw materials for the medical device market.
  • Companies marketing, installing or servicing medical devices.
  • Consultants providing design services to the medical device market.
  • Companies providing services to the medical device market such as sterilisation, cleaning, testing, etc.


  • Risk identification and management and enhanced product safety
  • Tool to develop management activities and ensure your business’s continuity, performance
  • Improves efficiency, your process quality and transparency
  • Provides confidence that best practice validation and GMP have been implemented and evaluated
  • Improved legal and regulatory or contractual requirements compliance
  • Systematic incorporation, at an early stage and within the design and development process, of the regulatory requirements impacting on the product itself and its technical features
  • Proactive error detection and prevention
  • Proven commitment to quality through an internationally recognized standard
    Raise brand reputation and consumer trust and satisfaction
  • Reduce operational costs by highlighting process deficiencies and improving efficiency
  • Avoid costly product recalls by delivering consistent quality and safety
  • Take advantage of our wealth of international experience, expertise and global presence in the medical devices market