Call 08048617705 67% Response Rate

Send Email

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
ISO 13485 certificate providers in Gujarat & in India
ISO 13485 certification agency in Gujarat & in India
ISO 13485 certification requirements
ISO 13485 certification process, ISO 13485 certification procedure may contact us.

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

Price on Request

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
Get Best Quote Request Callback
ISO 13485 Certification Consultants Gujarat India

ISO 13485 Certification Consultants Gujarat India

Price on Request

Product Details:
Certifications ProvidedISO 13485
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
ExpertiseMedical Devices System
Suppliers & Manufacturers of Medical devices looking to obtain ISO 13485 medical devices certification , ISO 13485 registration in ahmedabad in gujarat & in 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 in ahmedabad gujarat , ISO 13485 certifications in India, ISO 13485 certifications in Vadodara Baroda, ISO 13485 certifications in Surat Ankleshwar Bharuch, ISO 13485 certifications in Rajkot, ISO 13485 certifications in Maharashtra Rajasthan and in other states of India may contact us
Get Best Quote Request Callback

ISO 13485 Certification Consultants

Price on Request

Product Details:
Certifications ProvidedISO 13485
Document verification ModeOnline
Training Courses (if applicable)Internal Auditor Training
Services offeredConsultancy
Type of CertificationNew Certification
Type of IndustryFor Manufacturing
Mode of ReportSoft Copy
Certification Provided with inEstimated after prelimnary review
Document RequiredUpdated after prelimnary review
Service offered inPan India, Singapore, UAE, Gulf countries
ExpertiseMedical Devices Certification
Blue Sky is a leading ISO 13485 medical devices certification consultants, ISO 13485 certification consultancy, ISO 13485 certification service provider agency in ahmedabad, in Gujarat & in India.

Organizations searching to obtain

ISO 13485 certifications in ahmedabad gujarat india,
ISO 13485 medical devices qualty management system certification in ahmedabad gujarat india,
ISO 13485 medical devices provider certification consulting agency in ahmedabad gujarat india,
ISO 13485 registration consultants in gujarat india may contact us.

We can help organizations in achieving ISO 13485 certifications ISO 13485 registrations for organizations located ahmedabad vadodara baroda surat ankleshwar bharuch rajkot bhavnagar jamnagar himmatnagar gandhinagar gandhidham mumbai pune chennai calcutta gudgaon delhi noida and in other cities of India. Organizations looking to obtain ISO 13485 medical devices quality system certification in india 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
  13. other quality management system requirements as applicable
Organizations looking to obtain ISO 13485 medical devices quality management certification in gujarat india and searching for ISO 13485 medical devices certification consultants in ahmedabad gujarat india, ISO 13485 certification consultancy in ahmedabad gujarat india, ISO 13485 certification provider consulting agency in ahmedabad gujarat india may contact us.
Get Best Quote Request Callback

EXPLORE MORE CATEGORIES

Looking For "ISO 13485 certification Consultants"?
Thank youYour Enquiry has been sent successfully.
© Bluesky Management Services. All Rights Reserved (Terms of Use)Developed and managed by IndiaMART InterMESH Ltd.