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Services

Please take a quick overview of the speciality services provided by us.

With proven track record in industry our fleet of auditors are extensively trained and have been part of the elite forum of notified body auditors.  They bring unique expertise from industry perspectives and are in the forefront understanding and providing extensive backup for the client systems.

Audit management

Our comprehensive packages include custom tailored requirements of clients
  • We provide custom tailored and bespoke solutions for your auditing requirements. You do not have a trained and competent auditor? we can provide on-site and desktop process reviews based on quality systems and the requirements you specify.

  • Have a need for auditing a potential supplier or a critical vendor?  Through a trail of consents by the parties our auditors can arrange second party audits and send you the report.

  • Are you scheduled for a notified body or regulatory audits in a short? We provide mock audits for system readiness or process fitness check.

  • Our auditors experience being with notified bodies as reviewers can make significant difference to your product documentation (DMR/TF/DD) reviews

  • Have you been through transitions and having hard time complying to the requirements as like newer implementations like MDSAP, see us..

Product support

Plug into your target markets with the fully compliant and extendable product technical documentation we provide.
  • Are you a original manufacturer and not sure how to organise your product documentation for the agencies to review? Our data management solutions are rigid and robust for your needs.

  • Have you lost the control of product documentation with redundancies and consensus of product documentation in various markets? we are sure you will not go empty hand.

  • Are you having specific issues to market as active medical devices and compliance to electro-mechanical standards and territories like China and compliance to MDD and deviations of ISO14971 (Risk Management)?  You are at the right turn.

  • Is there specific product needs you are looking for like the D&D and other manufacturing, validation controls that you need backup, please see the range of solutions we have in our portfolio for you.

Quality system support

Time and circumstantial changes in markets, product range and changing school of thoughts require a functional management system.  Groom your system to enhance productivity.
  • Quality Systems are virtual machines that document and design the processes of the organisation to be instrumental for implementing the organisational values into the design and service provided in the form of product.  Where Quality systems need maintenance, designing, and efficient management for process interactions.  We provide niche expertise for

    • Management Reviews​

    • Internal Audits / Self inspections including CQA

    • Change management

    • Customer complaints

    • CAPA or Nonconformance systems as per organisations' complexity

  • We salvage the systems when time has lapsed in the events when you have rate limiting circumstances as NB/CBs' issuing little or no time for corrections.​

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