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ISO 13485 Medical Devices Certification Provider Agency Gujarat

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ISO 13485 Certification

Established in year 2004, Blue sky management services is an eminent ISO 13485 medical devices certification consultants in gujarat india, ISO 13485 certification consultancy in gujarat india, ISO 13485 certification provider agency in gujarat india, ISO 13485 certification consulting agency in gujarat india, ISO 13485 medical devices certification consultants agency.

Organizations looking to obtain ISO 13485 medical devices quality management system certification, ISO 13485 certification, ISO 13485 certificate, ISO 13485 medical devices quality system registration in gujarat india may contact us. We can help organizations in achieving ISO 13485 quality system certifications with organizations like TUV, BVQI, Intertek, and other UKAS ASCB ANAB RVA etc accredited certification agencies ISO 13485 certification bodies. Organizations interested in achieving ISO 13485 certifications may contact us.

Suppliers & Manufacturers of Medical devices looking to obtain ISO 13485 medical devices certification in ahmedabad gujarat india, ISO 13485 registration in ahmedabad gujarat india can contact us. We are leading ISO 13485 certification consultants in gujarat india, ISO 13485 certification consultancy in india, ISO 13485 certification provider consulting agency located at ahmedabad in gujarat india. We can help organizations located at ahmedabad vadodara baroda surat ankleshwar bharuch vapi valsad navsar gandhinagar gandhidham rajkot bhavnagar surendranagar delhi mumbai calcutta chennai jaipur udaipur pune jodhpur chandigadh lucknow and in other cities of india in achieving ISO 13485 medical devices certification.

We can help organizations in achieving ISO 13485 certifications with following scope of work

  1. Gape analysis against requirements of ISO 13485 certifications
  2. Suggesting actions to be taken to achieve ISO 13485 medical devices certifications
  3. Assisting in doing risk analysis
  4. Assisting in preparation of key documents such as Quality manual, Quality procedures
  5. Coordination with ISO 13485 certification agency till achievement of ISO 13485 certificate

Organizations looking to obtain ISO 13485 certifications may contact us.

Following are key requirements of ISO 13485 medical devices quality system certifications

  1. Preparation of quality manual and quality procedures
  2. preparation of quality policy and quality objectives
  3. Appointment of specific responsibilities as per national / international legal rules
  4. review of legal requirements
  5. Providing clean ,hygenic & product – production adequate work environment
  6. Reverting on advisory notices
  7. Clinical evaluations of product under development
  8. control of product installation and services
  9. validation of softwares
  10. validation of sterile medical devices
  11. Maintaining specific identification and traceability
  12. Risk management as per relevant risk management standard such as ISO 14971

Other quality management system requirements as applicable.