The preparation and review of technical documentation for the certification process generally takes around two (2) months, depending on the completeness of client submissions and the complexity of the management system. This timeframe covers the receipt of documents, preliminary review, clarification or additional information requests (if any), and final approval before moving forward to certification decision-making 

The verification and re-registration of certification typically requires approximately one and a half (1.5) months. This timeframe includes the review of existing certification records, verification of compliance with current requirements, scheduling and conducting the necessary audit activities, addressing any findings, and completing the decision process for re-registration to ensure continuous validity of the certification.  

The ISO 13485 certification process typically requires around two (2) months, depending on the readiness of the organization and completeness of documentation. This period generally covers application review, audit planning, Stage 1 and Stage 2 audits, evaluation of audit findings, and the certification decision process. Timely responses to any nonconformities by the client play an important role in ensuring the certification is issued within the expected timeframe. 

The certification process for Good Distribution Practice for Medical Devices (GDPMD) generally takes around two (2) months, depending on the organization’s preparedness and the quality of submitted documentation. This timeframe typically covers application and document review, audit scheduling, on-site audit, issuance of audit findings, and certification decision-making. Prompt closure of any nonconformities by the client is essential to ensure certification is granted within the expected duration.