ISO 13485 Certification

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ISO 13485 Certification Services In Ahmedabad

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 certificate image

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.

ISO 13485 Certificate image

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

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

Who Can Go For ISO 13485 Certification?

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

Benefits

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