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Packaging and sterilization validations are a critical step in the development and manufacturing of medical devices, as they ensure patient safety, regulatory compliance, product quality, and the ...

ISO 9001 enables an organization to adjust the documentation as applicable as long as the overall objectives are met.

Document control is the process of maintaining documents enforcing controlled procedures and practices for creation.

CAPA PROCESS STEPS The CAPA process comprises seven steps as highlighted below. Step-by-step risk-based CAPA process Identification Evaluation Investigation & Analysis Action Plan Review and ...

Change management is when an organization creates a step-by-step protocol to manage and implement modifications to products and processes. A change management plan is a protocol that implements and ...

A risk management plan (RMP) must be developed at the start of the risk management process for a new project or device development.

Records and Documents in QMS linking is a feature in QMS to help identify the pairs of relevant information representing the same entity.

Companies in the life sciences industry face challenges in developing and maintaining data integrity due to complex validation documentation.

ISO 13485:2016 is an international standard for medical device manufacturers and providers of quality management systems. ISO 13485:2016 is not a law or regulation and is voluntary, while FDA 21 CFR ...