ISO 13485 Certification

ISO 13485:20O3/AC 2009 Or EN ISO 13485:2012 Certificate will be issued by an accredited third-party after conducting ONSITE audit to check your compliance towards Medical Device Quality Management System.

We help you to implement and get your organization certified in Medical Device Quality Management System remotely and onsite.

We do GAP analysis followed by action plans to implement proper system by developing Manual, procedures, protocols, format, etc.

Our reputation and many years of working experiences with Certifying Agencies make the total process easy and affordable.

Our Certified and professionally qualified experienced Medical Device consultants make the process of Implementing ISO 13485 / 21 CFR 820 fast and on time.

How to achieve ISO 13485 Certificate?

The following are the important steps in ISO 13485 Certification.

  • Appoint experienced ISO 13485 Consultant.
  • Define scope of Certification.
  • Prepare Organization Chart and define each person’s duties and authorities.
  • Identify ISO 13485 standard / clause exclusions.
  • Drafting of Quality Manual and System Procedures.
  • Train the employees.
  • Internal Audit.
  • Certification audit by body.


ISO 13485 Consultants role in ISO 13485 Certification

  • Guidance and technical support.
  • Standard Interpretations and explain to process owner.
  • Drafting scope of Certification.
  • Support in Drafting of Quality Manual and System Procedures.
  • Employee awareness and Internal Audit training.
  • Support during internal Audit.

How much is the cost of ISO 13485 Certificate?

There is no fixed cost or fee structure for the ISO 13485 certificate or certification process. The fees depends on the following parameters.

  • Number of employees.
  • Certification Body selected.
  • Type of product /service and complexity of the process.
  • Number of outsourced activities.
  • Number of man-days spend by the consultant etc.
  • Experience of ISO 13485 Consultants.

Need an urgent Quote? Please answer the questions below and send us a mail. The concerned person will call you from the nearest location.

  • Name of the Medical Device manufacturer?
  • Number of employees.
  • Shop floor area in Sq.Ft.
  • Intended use of the device(s) you manufacturer.
  • Provide web link to understand more about your product and service.
  • Do you know the scope of ISO 13485 Certificate? Please mention. Target market.

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