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

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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 ...

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 ...

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.

Step-by-step instructions to write an effective Non-Conformance Report (NCR) To write an effective Non-Conformance Report, follow the below-listed steps. Identify and Control the Non-Conformance The ...

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 ...

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

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

Implementing CSA for lab systems offers several benefits, including faster deployment and a higher ROI by streamlining the validation process.