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Prove that your medical devices are working right

ISO 13485 is a certification that sets forth the standard of medical devices. Safety and quality assurance is important, especially in the case of medical equipments. To that end, prove that your medical devices fall upon the right standards with ISO-13485 certification.

Price Starts RS @ 14,999 /-

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ISO 13485 Certification Process

Step 1
Documentation
Step 2
Application Filling
Step 3
Application Assement
Step 4
Grant Of ISO 13485 Certification

What is ISO 13485 Certification in India?

When it comes to medical devices, two things are not compromise-able here, they are:

  1. The quality of the medical device
  2. The safety when you are using such devices

Therefore, the regulatory standards for such devices are especially stringent and must be followed through the entire life cycle of the medical device. This is not a matter of the eight qualities; many organizations must demonstrate that they can manage their medical equipment's quality. This demonstration comes in the form of ISO -13485:2016 certifications.

ISO-13485 sets the standards regarding the quality management system associated with the medical devices industry. If you want this Certification, you should get in touch with Registrationwala, and you can begin applying for the Certification.

Benefits of ISO 13485:2016 Certification

  1. The quality of the medical equipment is managed at the best level.
  2. With this Certification, you can gather the trust of medical industries.
  3. The company's credibility and image will improve.
  4. Customer satisfaction will improve as well.
  5. The process of quality management for medical devices is further improved. 
  6. The employees are going to look forward to continually improving themselves.

More about the ISO 13485 Certification

What is the ISO 13485 standard? It is a primary Quality Management System standard for medical devices. It is not ubiquitous per se, as several countries have their own QMS regulations. For instance, the US plans to harmonize the FDA, i.e., the Food and Drug Administration requirements for medical devices, by the ISO 13485 standards. The scope of the Quality Management System can be tailored to an organization. The current version is ISO 13485 is the ISO 13485:2016 certification, published in March 2016.

Organization Size Dependency

ISO 13485 can be implemented irrespective of the size of the organization

Non-applicability for Product Standardization

ISO 1385 is not applicable for product standardization, as it does not define product quality. ISO is a process-based standard. The applicant can use it to control his or her processes so that the end product meets the desired results.

ISO 13485 is a Non-personal Standard

ISO is a non-personal standard. An individual cannot get certified to ISO 13485 standards. Only an organization or a company can become ISO-certified. But there is a provision for an individual to gain the ISO 13485 certification. He can obtain an ISO 13485 Certification as a Lead Auditor after a 5-day training course. With such a certificate, he or she can audit other companies.

ISO as a Non-Membership Group

ISO 13485 is a non-membership group. You cannot join ISO 13485 family. To become ISO certified, your organization must conduct the following operations:

  • Implement an ISO 13485 standard's QMS
  • Further, the Certification Body or a Registrar audits the performance of the organization as per the latest version of ISO 13485.
  • If the applicant passes the audit, the Registrar issues the ISO 13485 Certificate. This certificate issue demonstrates the organization has been registered to ISO 13485 for the next three financial years.
  • The ISO-certified organization must re-certify every three years to maintain the ISO certification.

Eligibility Criteria for ISO 13485 Certification in India

Before applying for ISO 13485 Certification, you must adhere to the points specified in ISO 13485 standards. For that purpose, you need to train your organization as per this standard.

Documents required for ISO 13485 Certification in India

The documents that are required to file the application for ISO 13485 Certification are as follows:

  • A copy of the PAN card
  • A Passport Sized photograph
  • A copy of the Voter Identity Card (that would be your address proof)
  • Two copies of the sales or purchase bill that your company does
  • Policy document of the Information security system

Process of obtaining the ISO 13485 Certification in India

The process for ISO 13485 certification is mentioned below:

  1. Gathering the documents
  2. Submitting the application for ISO 13485 Certification
  3. Letting the application and an auditor assess the procedure document
  4. Obtain the certification if the auditor agrees

Registrationwala will assist you through the filing and registration process and provide you with the certification.

Our Assistance in getting the ISO 13485 Certification in India

Registrationwala can assist you with the registration by providing you with the following services:

  1. Selection of certification type
  2. Document aggregation
  3. Draft approval
  4. ISO 13485 Certification

Improve the energy efficiency of your business. Show that your medical devices work right and as per the standard by getting ISO 13485 Certification with the aid of Registrationwala.

FAQs

Q 1. What is ISO 13485 certification in India?

A. When it comes to medical devices, two things are not compromisable here, the quality of the medical device and safety when using such devices. Therefore, the regulatory standards for such devices are especially stringent and must be followed through the entire life cycle of the medical device. This is not a matter of the eight qualities; many organizations must demonstrate that they can manage their medical equipment's quality. This demonstration comes in the form of ISO -13485:2016 certifications.

Q 2. What is the scope of ISO 13485 certification?

A. ISO 13485 standard is a primary Quality Management System standard for medical devices. It is not ubiquitous per se, as several countries have their own QMS regulations. For instance, the US plans to harmonize the FDA, i.e., the Food and Drug Administration requirements for medical devices, by the ISO 13485 standards. The scope of the Quality Management System can be tailored to an organization. The current version is ISO 13485 is the ISO 13485:2016 certification, published in March 2016.

Q 3. Is the ISO 13485 certification sought for medical devices?

A. Yes. There are various benefits of gaining the ISO 13485 certification in India:

  • The quality of the medical equipment is managed at the best level.
  1. With this Certification, you can gather the trust of medical industries.
  2. The company's credibility and image will improve.
  3. Customer satisfaction will improve as well.
  4. The process of quality management for medical devices is further improved. 
  5. The employees are going to look forward to continually improving themselves.

Q 4. What is the required eligibility for the ISO 13485 certification?

A. Before applying for ISO 13485 Certification, you must adhere to the points specified in ISO 13485 standards. For that purpose, you need to train your organization as per this standard.

Q 5. How to get ISO 13485 certification in India?

A. To get the ISO 13485 certification in India, refer to the process section of this web page. We have briefed you on every aspect of the ISO 13485 certification in India. To know more about the ISO family standards, connect with the ISO experts at Registrationwala. Our seasoned professionals will detail every aspect of the ISO certification procedure in India.

Q 6. What is the validity of the ISO certificate in India?

A. The ISO-certified organization must re-certify every three years to maintain the ISO certification. Every ISO certificate is valid only for a period of three years. To know more about the ISO family standards, connect with the ISO experts at Registrationwala. Our seasoned professionals will detail every aspect of the ISO certification procedure in India.

Q 7. Explain the procedure for ISO 13485 accreditation in India.

A. To get ISO 13485 accreditation in India, refer to the process section of this web page. We have briefed you on every aspect of the ISO 13485 certification in India. To know more about the ISO family standards, connect with the ISO experts at Registrationwala. Our seasoned professionals will detail every aspect of the ISO certification procedure in India.

Q 8. What is the ISO 13485 certification cost in India?

A. To know the certification fee for ISO 13485 standards, connect with the ISO experts at Registrationwala. Our seasoned professionals will detail every aspect of India's ISO 13485 certification procedure.

Q 9. How to get the ISO 13485 certification for Hampi Equipments LLP?

A. To get ISO 13485 certification for Hampi Equipments, refer to the process section of this web page. We have briefed you on every aspect of the ISO 13485 certification in India. To know more about the ISO family standards, connect with the ISO experts at Registrationwala. Our seasoned professionals will detail every aspect of the ISO certification procedure in India.

Q 10. What is the ISO 13485 certification process in India?

A. To know the ISO 13485 certification process in India, refer to the process section of this web page. We have briefed you on every aspect of the ISO 13485 certification in India. To know more about the ISO family standards, connect with the ISO experts at Registrationwala. Our seasoned professionals will detail every aspect of the ISO certification procedure in India.

Q 11. What is the history of ISO 13485 standards?

A. To know the history of ISO 13485 standards in India, refer to the process section of this web page. We have briefed you on every aspect of the ISO 13485 certification in India. To know more about the ISO family standards, connect with the ISO experts at Registrationwala. Our seasoned professionals will detail every aspect of the ISO certification procedure in India.

Q 12. Where can I find a list of ISO 13485 registered companies in India?

A. You can download the list of ISO-certified companies in India from the official ISO website in India.

Q 13. How much does ISO 13485 certification cost?

A. To know the certification fee for ISO 13485 standards, connect with the ISO experts at Registrationwala. Our seasoned professionals will detail every aspect of India's ISO 13485 certification procedure.

Q 14. What is the validity of the possession certificate for ISO 13485 standards?

A. The ISO-certified organization must re-certify every three years to maintain the ISO certification. Every ISO certificate is valid only for a period of three years. To know more about the ISO family standards, connect with the ISO experts at Registrationwala. Our seasoned professionals will detail every aspect of the ISO certification procedure in India.

Q 15. What is the non-applicability for ISO product Standardization?

A. ISO 1385 is not applicable for product standardization, as it does not define product quality. ISO is a process-based standard. The applicant can use it to control his or her processes so that the end product meets the desired results.

Q 16. Is ISO 13485 a Non-personal Standard in India?

A. ISO is a non-personal standard. An individual cannot get certified to ISO 13485 standards. Only an organization or a company can become ISO-certified. But there is a provision for an individual to gain the ISO 13485 certification. He can obtain an ISO 13485 Certification as a Lead Auditor after a 5-day training course. With such a certificate, he or she can audit other companies.

Q 17. Is the ISO family a Non-Membership group?

A. ISO 13485 is a non-membership group. You cannot join ISO 13485 family. To become ISO certified, your organization must conduct the following operations:

  • Implement an ISO 13485 standard's QMS
  • Further, the Certification Body or a Registrar audits the performance of the organization as per the latest version of ISO 13485.
  • If the applicant passes the audit, the Registrar issues the ISO 13485 Certificate. This certificate issue demonstrates the organization has been registered to ISO 13485 for the next three financial years.

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