Master ISO 13485:2016 certification with ClariMed's expert tips. Enhance your medical device QMS for regulatory compliance and quality assurance.

Explore 5 document control best practices to enhance product development. Learn how to streamline operations, improve compliance, and revolutionize your quality management process.

Known Use Problem Summary: A crucial tool for identifying and mitigating medical device use-related risks.

Key differences in human factors processes for medical devices vs. combination products: FDA perspective.

FDA issues draft guidance on dosage labeling for prescription drugs and biologics; comments due 3/14/2023.

Optimize medical device usability: Formative evaluations guide design, reduce costs, and improve outcomes.

Comparing NMPA and FDA human factors guidance: Key differences in medical device regulation in China vs US.

FDA updates drug and biologic IFU guidance: Key changes in content, readability, and usability requirements.

Medical device recalls: Rising trends, financial impacts, and how human factors engineering can mitigate risks.

FDA inspections, Form 483s, and warning letters: Implications for medical device manufacturers and prevention.

Medical device user training: Key findings on effective methods for healthcare providers from ClariMed study.

FDA-funded study by ClariMed explores training decay in medical device usability. Pilot results show task success varies with training periods.

Examine Brexit's impact on medical device usability regulations. Discover key differences between UK and EU requirements for implant information and post-market surveillance under the new MDR.

Key human factors considerations for combination products: Comparing CDER and CDRH FDA guidance.

FDA guidance on bridging human factors data for combination products: Analysis and submission tips.

On May 13, 2020, the FDA hosted a Virtual Town Hall for COVID-19 test manufacturers, addressing updates to Emergency Use Authorization (EUA) guidelines and validation for antigen tests.

A guide to enhancing medical device complaint management through human factors integration. Improve data collection, analysis, and resolution of use-related issues.

A summary of FDA's latest COVID-19 updates, including EUA process, N95 mask reuse, and upcoming town halls on diagnostic tests. Essential info for medical device manufacturers.

A comprehensive overview of FDA's guidance for clinical trials and usability studies during COVID-19, covering safety measures, protocol changes, and reporting requirements.

A comprehensive overview of FDA's regulatory changes for face masks and respirators in response to COVID-19, including Enforcement Policy and Emergency Use Authorizations.

A comprehensive overview of ISO 14971:2019 updates, focusing on key changes in risk management processes and their impact on human factors engineering for medical devices.

A comprehensive overview of the 2016 FDA Human Factors Guidance, covering key requirements for medical device validation testing and submission.

An in-depth look at Human Factors Engineering for FDA submissions and the importance of perceived quality in medical device design, development, and user experience.

Discover how Reverse Human Factors Engineering enhances medical device clinical trials by minimizing use errors and tracking human variability for better outcome analysis.

ClariMed proposes a new definition for "Normal Use" in medical device usability, addressing real-world user behaviors and improving usability validation testing methods.

Expert advice from FDA's Human Factors Reviewer on improving medical device submissions. Covers risk analysis, validation testing, and addressing FDA feedback.

ClariMed shares key takeaways from the IEC 62366-1:2015 update, covering unintended users, lay vs. professional use, and symbol usage in medical device usability standards.

ClariMed's insights on connected medical devices, digital health applications, and FDA usability requirements from their workshop at the SMi conference in London.

Jeff Durney's perspective on applying aviation safety principles to healthcare, focusing on surgical checklists, training, and safety reporting to improve patient outcomes.

An overview of cognitive bias in usability studies, its potential impact on results, and strategies for identifying and mitigating these subconscious influences.

A detailed guide to the FDA's human factors engineering process for medical devices, covering user research, risk analysis, prototyping, testing, and regulatory submission.

An in-depth look at how FDA guidance on human factors in medical device design evolved from 2000 to 2011, highlighting key changes and their significant impact on manufacturers.

This post analyzes differences between IEC 62366-1:2015 and FDA's 2011 Human Factors Guidance for medical devices, covering unique aspects of each standard for usability engineering.

A comprehensive guide to the 5 key phases of Usability Engineering for medical devices, covering research, risk analysis, testing, validation, and regulatory compliance.