The shift from QSR to QMSR is now in full effect. The FDA has aligned 21 CFR Part 820 with ISO 13485:2016, effective Feb 2026. While this alignment eases global compliance, many MedTech companies ...

As the pace of digital transformation and automation accelerates, the need for a robust and lean risk assessment methodology for software is becoming more and more critical in the life sciences ...

The development of new medical devices or any new project brings a new set of risks. A Risk Management Plan (RMP) must be developed at the start of the Risk Management Process for a new project or ...

In the life sciences industries, documentation plays a crucial role in proving the product's effectiveness and safety. Furthermore, it discusses the processes and practice's dependability, ...

Computer Software Assurance (CSA) is a new methodology that takes a risk-based approach to validation activities. It was driven by the FDA and life sciences industry to streamline verification and ...

The US Food and Drug Administration (FDA) is responsible for protecting public health by ensuring medical devices' safety, efficacy, and quality. The agency has developed a rigorous medical device ...

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 ...

Bringing medical devices to market is a highly complex, challenging, and regulated process. Medical device manufacturers bear the responsibility of ensuring the safety and effectiveness of their ...

Organizations must develop a written method to approve papers for sufficiency prior to issuance. Documents should be reviewed, updated as needed, and re-approved. Determine the changes and the current ...

Navigating FDA 21 CFR Part 11 compliance requires a strategic approach to Computer System Validation (CSV)and Computer Software Assurance (CSA). Title 21 of the Code of Federal Regulations establishes ...

The different processes involving multiple roles like supplier, production, manufacturer, and pieces of equipment for designing or marketing a product will inevitably invite some non-conformance ...

In the realm of Computer System Validation (CSV), risk assessment stands as a cornerstone in ensuring the safety, efficacy, and compliance of software systems, particularly in regulated industries ...