This session will highlight “AI Governance Strategic Imperative in MedTech: Empowering Organizational Reputation, Compliance, and Innovation” hosted by Compliance Group Inc to equip MedTech leaders ...

Explore AI governance in MedTech. Learn about regulatory risks, compliance & strategy in our expert-led webinar. Stay ahead in health tech innovation.

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

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

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 ...

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 ...

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

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

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 ...

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

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.