ISO 13485 Consultancy / Certification

ISO 13485 Certification for Medical Devices is a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.

We support our clients to

Create the documents for ISO 13485 certification
Train in requirement of ISO 13485 standard
Create SOP`s, work instructions, Quality Manuals, VMP’s, Process Validation documentation etc.
Implement the system at Shop Floor and provide the need-based training to make sure that the system is adequately implemented
Monitor the system on routine basis which includes Management review meetings, Internal quality audits, Customer complaints, CAPA Management, Handling of non-confirming products etc.

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