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Revolutionizing Robotics: A Case Study on Polarion Risk Management Implementation by Compliance Group, Inc., for a Leading Global Innovator in Medical Technology ...

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

That’s where our AI-Enhanced Requirement & Test Management Platform makes a difference.

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.

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.

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 ...

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

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 ...

Article Context: Computer System Validation Computer System Assurance CSA (vs) CSV Advantages For health and life sciences organizations, compliance with regulatory requirements is non-negotiable.