Assistance in ISO 13485 Certification in India in India


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    Cliniexperts provides an end-to-end regulatory solution for the domestic and international markets. CliniExpert team is fully updated on the latest IVD regulatory requirements and ISO certification requirements. Manufacturers or importers who wish to apply for the ISO 13485 Certificate can approach the professionals at CliniExpert; they will provide complete support through every step of the regulatory process.

    Assistance in ISO 13485 Certification in India– Overview


    The purpose of this service is to assist in ISO 13485 certification process. ISO 13485 Certificate is an important Certification required by the manufacturers, designers, suppliers, distributors, and service providers of all medical devices including in vitro devices (IVDs).

    The regulatory body involved in the process is the Accredited Notified Body. The following procedure needs to be followed to avail the ISO 13485 certificate:

    • Applicant needs to establish Quality Management as per ISO 13485 standards and implement them in the organization
    • Upon implementation applicant can reach out to the Accredited Notified Body for an audit of the organization and certification.
    • The timeline for the process is 6 to 9 months.

    Who Can Apply?


    The Designers, manufacturers, suppliers, service providers, and distributors of IVDs can apply for the ISO 13485 certification.


    How To Apply?

    Applicant must define the scope of the ISO 13485 Certificate, which will mention the objectives and scope of the certificate.
    Applicant must select the notified body
    Applicant must establish a quality management system
    Applicant must work according to the established quality management system
    Prepare for the audit
    Get audited by the Accredited Notified Body. The notified body will audit the company for two to ten days, depending on the size of the organisation. The organisation will obtain the certificate(s) if it passes the audit.

    Fee Involved

    The Government charges specific fees for the ISO 13485 certification process, which depends on the size and scope of the certificate.

    Validity

    The validity of the ISO certificate depends upon the notified body.

    Important Documents

    The following list of documents is required for the application process: Quality Manual IVD details file Procedure for design and development Document control procedure Training Procedure

    Timeline to get Form from Central Drugs Standard Control Organisation

    6 to 9 months

    Essential Tips

    The following tips will be beneficial during the application process:

    Applicant must establish Quality Management System before the certification audit


    Applicant should ensure every stakeholder is trained


    Preliminary internal audit must be performed before the external audit to ensure the training efficacy. The following problems can be faced during the process, and must be avoided by good mock audit and thorough training:


    Lack of adequate resources


    Lack of qualified resources


    A compliant culture of laxity

    Expert Advise

    Experts at CliniExperts provide the following advice: Management team and seniors should thoroughly review the quality management system for any loopholes and try to overcome them before the actual audit.

    The team should work according to Standard Operating Procedures and WIs

    Applicant must ensure external suppliers should be audited

    All computerized systems should be validated

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    Frequently Asked Questions

    Does compliance to ISO 13485:2016 demonstrate GMP?

    No. ISO 13485:2016 does not demonstrate compliance with GMP. They are separate requirements.

    Why is the ISO 13485 certificate necessary?

    The ISO 13485 certificate is essential to implement a Quality Management Systemto achieve a high level of control, focus on safety, and tough requirements and standards that can benefit the manufacture of IVDs or its components.

    Is ISO 9001 certificate sufficient to establish QM System?

    No. The ISO 9001 certificate is not enough to establish a certified QM System an ISO 13485 certification is required to prove compliance with regulatory requirements of medical devices

    What is the current version of ISO 13485?

    The latest revision of ISO 13485 for QMS in IVDs companies is available from March 2016.

    Does ISO 13485:2016 only apply to medical devices?

    Yes. The ISO 13485 isestablished explicitly for companies working in the IVDs field.

    Are there testing requirements for ISO 13485?

    There are no special requirement of testing , but standards must be met.

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