Medical Devices ISO 13485:2016 Certification

ISO 13485 is a Quality Management Systems Requirements for Medical Device Regulatory Purposes

What Is ISO 13485?

ISO 13485 specifies requirements for a Quality Management System that can be used by an organization involved in one or more stages of the life cycle of a medical device including:

  • Design and Development,
  • Production,
  • Storage and Distribution,
  • Installation and Servicing,
  • Decommissioning and Disposal of medical devices, and that the related services consistently meet customer requirements and applicable regulatory requirements. The fundamental purpose of ISO 13485 is to promote harmonized medical device regulatory requirements for QMS. ISO 13485 is a standalone standard.

Who Can Use ISO 13485?

The requirements of ISO 13485 can also use by suppliers or other external parties providing products such as:

  • Raw materials,
  • Components and subassemblies,
  • Sterilization services,
  • Calibration services,
  • Distribution services, and
  • Maintenance services

The revised standard includes the need for a risk-based approach to the QMS, an improved focus on regulatory requirements and the responsibilities of top management, raised controls over suppliers and outsourced activities, and priority on risk management throughout the product lifecycle.

How To Achieve ISO 13485 Certificate?

Following are the important steps followed by MedDeviceCorp 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 and clause exclusions
  • Drafting of Quality Management and System procedures
  • Train the employees
  • Internal audit
  • Certification audit by body

Why MedDeviceCorp?

Role of MedDeviceCorp in ISO 13485 certification:

  • Guidance and Technical Support
  • Standard Interpretations to explain process owner
  • Drafting the scope of certification
  • Support in drafting for quality manual and system procedures
  • Employee awareness and internal audit training
  • Support during the internal audit

Cost of ISO 13485 Consultancy And Certification

MedDeviceCorp decides the fees depending on the following parameters:

  • Number of employees
  • Certification agency selected
  • Type of product/service and complexity of the process
  • Number of outsourced activities
  • Number of man-days spend on the consultants etc.
  • Experience of ISO 13485 consultants

ISO 13485: 2016 Implementation And Certification Timeline

Post appointing MedDeviceCorp, it takes approximately 4 weeks for drafting the documentation and additional 4-6 weeks for implementation in a mid-sized organization with 30 employees.

Larger firms with more than 50 employees and / or multiple locations require more time. The timeframe for certification is also dependent upon the availability of Certification agency and their approved auditors to audit and certify your company.

More information writes to us with device details to

ISO 13485 Consultants