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When it comes to medical devices, two things are not compromise-able here, they are:
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.
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.
ISO 13485 can be implemented irrespective of the size of the organization
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 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 13485 is a non-membership group. You cannot join ISO 13485 family. To become ISO certified, your organization must conduct the following operations:
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.
The documents that are required to file the application for ISO 13485 Certification are as follows:
The process for ISO 13485 certification is mentioned below:
Registrationwala will assist you through the filing and registration process and provide you with the certification.
Registrationwala can assist you with the registration by providing you with the following services:
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.
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.
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.
A. Yes. There are various benefits of gaining the ISO 13485 certification in India:
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.
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.
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.
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.
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.
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.
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.
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.
A. You can download the list of ISO-certified companies in India from the official ISO website 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.
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.
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.
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.
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:
