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An organization-wide efficient and effective quality management system (QMS) is crucial, but the implementation is challenging. This article outlines factors that affect the QMS and provides guidance on controlling them with a pragmatic, risk-based approach that fosters stakeholder engagement. It addresses identifying needs and mapping activities and processes and explains how to prioritize and refine procedures and templates, manage training, and adapt to changes.

Regulatory authorities expect that clinical evidence for a software as medical device (SaMD) is generated with a scientific level of rigor that is commensurate with their risk and impact, and provide assurance of safety, effectiveness, and performance. As the range and scale of potential uses of artificial intelligence (AI) and machine learning (ML) for healthcare raises, new issues related for premarket clinical evaluation become apparent. Regulators across the globe focus their efforts on developing robust regulatory frameworks and the unified industry standards for risk classification and evaluation of medical AI, that safeguards against potential risks while balancing innovation.Keywords – AI/ML-based SaMD, clinical evidence, SaMD, software evaluation

This article applies to software development and validation and discusses the security and usability engineering aspects of software. It uses the term 'software” for software as a medical device (SaMD) and medical device software (MDSW), including MDSW that is embedded on, drives, or influences the use of a hardware medical device, software accessories, and software components. Keywords – agile development; incremental software; static waterfall

The digital health sector is experiencing enormous growth globally. Briefly, digital health is a branch of healthcare that is primarily focused on improving health using internet, digital, and mobile technologies. One such novel subclass of the digital health ecosystem is digital therapeutics (DTx). DTx are 'software-driven,” nonpharmacological therapeutic interventions that can improve the accessibility and effectiveness of healthcare. This article explores the current digital health ecosystem, the value proposition of digital therapeutics, and how frameworks for software as a medical device (SaMD) can be leveraged for regulatory success for these new-age therapeutics.Keywords – digital health, digital technology, digital therapeutics, DTx, mobile applications, medical device software, MDSW, software as a medical device, SaMD

This article provides two regulatory leaders insight on human factors engineering considerations for helping manufacturers optimize user interfaces and successfully meet regulatory expectations to bring safe, effective and usable medical devices to market. It was developed from an interview with Shannon Hoste, team lead of the Center for Devices and Radiological Health's (CDRH's) human factors premarket evaluation team and Michael Ryan, acting deputy director in the division of anesthesiology, general hospital, respiratory, infection control, and dental devices.

Human factors engineering (HFE), unique device identifiers (UDIs) and restriction of hazardous substances (RoHS) have more in common than one might think. At the recent 2014 RAPS San Francisco Bay Area Chapter’s annual educational conference, attendees gathered to enhance their understanding of HFE, the requirements for UDI and the impact of the RoHS 2 Directive 2011/65/EU1 aimed at devices currently under Directive 93/42/EEC (MDD) and 90/385/EEC (IVD).

Imagine yourself in this situation: you just started working for a new company and you review the risk management file you need to include in the next device submission. After recognizing that the risk management process itself is deficient, should you bite the bullet and address this more fundamental issue first, but risk delaying the submission in exchange for mid- and long-term benefits? If you decide this is the best course of action for you and your company, this article is for you.