Ensure your AI systems in MedTech meet compliance standards. Join our webinar on AI governance strategy and regulatory best ...

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

The validation process for USFDA medical device applications can be pretty complex and time-consuming. The first step in the validation.

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 ...

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 ...

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

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

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

Development of AI/ML (Artificial Intelligence/Machine Learning) technologies has raised concerns regarding regulatory compliance. CSA/CSV (Computer Software Assurance / Computer System Validation) ...