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November 23rd, 2022

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Are You Looking For Medical Devices Certifications?

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Internal Audit

The standard ISO 13485:2016, requires the manufacturers of medical device to perform internal audits at planned intervals. Internal audit supports the effectiveness of the QMS and ensure that the products manufactured are safe and effective. The qualified internal auditors of an organization can perform these audits but a professional, third party involvement is more objective when accessing the effectiveness of QMS and process with an independent and unbiased perspective. Appointing a third party auditor can curb the requirement of permanently hiring additional qualified team or training an entire team from existing employees.

Maven Profcon Services LLP, has a team of qualified internal auditor and the team can perform the internal audit to ensure the effectiveness of QMS with scrutiny, identify the gaps that disturb the flow of regular production and post production activities. If you do not wish to outsource this process, Maven also provides ISO 13485 internal auditor training and certification to qualify the medical device manufacturers and their employees as Internal auditors.

  • Scientific validity
  • Analytical performance
  • Clinical performance
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Audit Support

ISO 13485:2016 certification:

The certification cycle is for three years. Hence this cycle has initial certification audit, followed by surveillance audit next year, followed by recertification audit.

Maven performs a systematic review of the scientific literature, checks the adequacy of existing testing performed and develops performance evaluation plan along with a compliant Performance Evaluation Report (PER).

  • Initial Certification Audits: The initial certification audits are performed in 2 stages- stage 1 audit is performed to check the readiness of organization for stage 2 audit, if the minimum criteria are met for stage 1 audit, the body will process to stage 2 audit. In stage 1 audit, the certification body will check the QMS documentation which includes your quality manual, quality procedures and formats. While in stage 2, the certification body actually check the implementation of your QMS, for eg. whether all processes and results are recorded or not.
  • Surveillance Audits: The main purpose of surveillance audits is to find out whether all incidents are recorded, all measurements are recorded, proper CAPA is recorded, implemented and effective, the top management provides and inspects the system etc. in other words to check whether the documented system really works or not. The surveillance audits shall also focus on the NCs or observations of initial certification audit or previous surveillance audits.
  • Recertification Audits: recertification audits are conducted before the end of validity of the certificate. In recert audits a review of QMS documentation along with results of previous surveillance audits over the period of time of certification is performed.

For CE Certification:

The certification cycle is of five years- Initial certification audit, followed by 3 surveillance audits annually and a recertification audit.

Notified bodies once in five years shall perform at least 1 unannounced audit onsite. Where appropriate manufacturer’s suppliers or sub-contractors are also audited which may be combined with CE surveillance audits.

During the CE certification and CE surveillance audit, assessment of technical documentation and its update will be performed along with the verification of effective QMS implementation. The manufacturing facility will be closely observed and the man-material movement will be scrutinized.

Maven Profcon Services LLP, has a team of QMS consultants, who can help you with following:

  • Conducting mock audits before the NB audit
  • Updating the QMS documentation
  • Support during the audit
  • After audit, help you solve the non-conformities and ensure proper corrective and preventive actions are defined
  • Check the effectiveness of corrective and preventive action

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