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

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 ...

Conversational AI Assistant1512 Artaius Pkwy, Suite #104 Libertyville, Illinois, United States, 60048 [email protected] ...

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.

Title 21 CFR Part 11 is the portion of Code of Federal Regulations that provides standards determined by the Food and Drug Administration (FDA) on electronic records and electronic signatures. With ...

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

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 ...

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

In the life sciences industries, documentation plays a crucial role in proving the product's effectiveness and safety.

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

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 ...