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ISO 13485 certification Consultants

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

We can help organizations in achieving ISO 13485 medical devices quality system certifications in gujarat & in India.

Medical device manufacturers, Medical device manufacturing organizations searching for

ISO 13485 certification consultants in Gujarat & in India
ISO 13485 certification consultancy in Gujarat & in India
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We can provide ISO 13485 medical devices certification consultancy services to organizations located atAhmedabad Vadodara Baroda Surat Ankleshar Bharuch Vapi Valsad Navsari Rajkot Jamnagar Bhavnagar Amreli Morbi Himmatnagar Surendra Nagar Mahesana Kadi Kalol Chhatral Palanpur Siddhpur Unjha Kutch Gandhinagar Gandhidham Mundra & in Other Parts Of Gujarat, Delhi, NCR, Noida, Gurgaon, Gurugram, Mumbai, Pune, Maharashtra, Jaipur, Udaipur, Rajasthan, Patna, Bihar, Punjab, Hariyana , Chandigadh, Delhi, Noida, Bhopal , Madhya Pradesh, Lucknow , Uttar Pradesh, Kolkata , West Bengal, Bhuvaneshwar, Cuttack, Calicut, Odisha, Kerala, Karnataka, Andhra Pradesh, Tamilnadu, Telangana, Chennai, Andhra Pradesh, Hyderabad, Bengaluru, Chennai , Goa And In Other Parts Of India And Abroad.
ISO 13485 Medical devices Certification Services

ISO 13485 Medical devices Certification Services

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Product Details:
Certifications ProvidedISO 13485
Target LocationPan India
Document verification ModeOnline
Training Courses (if applicable)Internal Auditor Training
Services offeredConsultancy
Type of CertificationNew Certification
Type of IndustryMedical devices
Mode of ReportSoft Copy
Certification Provided with inEstimated after prelimnary review
Document RequiredUpdated after prelimnary review
Organizations searching for ISO 13485 medical devices certification consultants in ahmedabad, in Gujarat & in India, ISO 13485 medical devices certification consultancy in ahmedabad, in Gujarat & in India, ISO 13485 medical devices certification providers in ahmedabad, in Gujarat & in India.


Following are key requirements of ISO 13485 medical devices certification. 

  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
  13. other quality management system requirements as applicable

We can provide ISO 13485 medical devices certification consultancy services to organizations located at Ahmedabad Vadodara Baroda Surat Ankleshar Bharuch Vapi Valsad Navsari Rajkot Jamnagar Bhavnagar Amreli Morbi Himmatnagar Surendra Nagar Mahesana Kadi Kalol Chhatral Palanpur Siddhpur Unjha Kutch Gandhinagar Gandhidham Mundra And In Other Parts Of Gujarat, Delhi, Gudgaon, NCR, Noida, Patna, Bihar, Punjab, Hariyana , Chandigadh, Delhi, Noida, Bhopal , Mumbai, Pune, Maharashtra, Jaipur, Udaipur, Rajasthan, Madhya Pradesh, Lucknow , Uttar Pradesh, Kolkata , West Bengal, Bhuvaneshwar,  Odisha, Kerala, Karnataka, Andhra Pradesh, Tamilnadu, Telangana, Chennai, Andhra Pradesh, Hyderabad, Bengaluru, Chennai , Goa And In Other Parts Of India And Abroad
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