Risk Management is a vital component to developing and designing medical devices. Before your product goes to market, you have to know that it is safe and that you've analyzed and mitigated every risk ...

Filing medical device reports (MDRs) is undesirable and presents a certain amount of risk to the manufacturer. Fortunately, this risk can be ameliorated by approaching event reporting mindfully and ...

COLUMBUS, OH – Device manufacturers need to keep their risk documentation up to date throughout the total product life cycle by monitoring production and post-production information, according to LCDR ...

In today’s highly connected world of healthcare, medical devices have become fully integrated elements of patient care and treatment. But a high scale of deployment also brings greater exposure to ...

ISO 14971 provides a framework for medical device manufacturers to identify and minimize risks through the design and manufacturing processes. Adhering to the standard helps ensure overall safety and ...

These definitions as written out by AAMI (The Association for the Advancement of Medical Instrumentation) offer clarity, helping designers recognize and address these risks effectively in product ...

Weak authentication for medical devices (or a lack of it) has become a sweet spot for cyber criminals. Hackers accessed 1.2 million medical devices and exposed sensitive and protected information ...

The FDA released their updated guidance on Cybersecurity in medical devices: Quality System Considerations and content for Premarket submissions at the end of June in 2025. In this guidance the FDA ...

Evolving regulatory requirements and AI capabilities are reshaping quality management in the medical device industry. With increasing focus on compliance, traceability and patient safety, ...

Trust is one of the greatest investments anyone could make in healthcare. Patients who put their lives in the hands of healthcare institutions and personnel do so with an unmitigated amount of trust, ...

Safety risk management of medical devices is governed by the international standard: ISO 14971. Besides understanding the formal requirements of ISO 14971, successful risk management requires the ...

Regulatory Authorities are challenged to keep their markets open and to ensure that patients have proper access to devices while at the same time keeping non-compliant, possibly dangerous devices away ...