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CDAKB

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The CDAKB is a series of guidelines put in place to standardize quality control across the Indonesian medical device market. 

What is it?

CDAKB was put in place to regulate quality control across medical devices distributed in Indonesian markets. It affects all major aspects of distribution, including handling of products and record keeping. The CDAKB makes it so that in the event of a product recall there is a clear pipeline of access to the distributors/manufacturer in order to ensure complete user safety.

Services that comes with CDAKB

  1. Quality management system

  2. Resource management

  3. Building and facilities 

  4. Storage and inventory handling 

  5. Product traceability  

  6. Complaint handling 

  7. Field safety corrective action 

  8. Return system 

  9. Destruction system 

  10. Illegal and unqualified medical devices recording 

  11. Internal audit 

  12. Management review 

  13. 3rd party / Outsourcing activity 

Get in touch with us.

Our Consultants in QuikQuality has many years of experience in setting up CDAKB processes and procedures for manufacturers, OEM and suppliers. Contact us for more information on the pricing and procedures!

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