Risk Management Lessons from a Class I Recall

A class I recall of a pediatric device used to provide life-critical breathing support offers important lessons for Risk Management

Risk ManagementNaveen AgarwalFebruary 10, 2020Class I Recall, Pediatric Device Recall, Babi.Plus Pressure Relief Manifold, Babi.Plus Pressure Relief Manifold recall, quality management system, QMS, Bubble CPAP system, medical device recall, medical product recallComment

5 Key Changes in ISO 14971:2019

The third edition of ISO 14971, just published, aims to clarify requirements and improve effectiveness of medical device risk management.

Regulatory ComplianceNaveen AgarwalJanuary 14, 2020ISO 14971, ISO 14971:2019, Medical Device Risk Management, Understanding ISO 14971:2019, FDA Risk Requirements, Quality Management System, risk management planComment

Risk Management Tools and Tips for Project Managers

Risk management is critical to the success of any project. Here are a few tools and tips you can use to manage project risks.

Risk ManagementNaveen AgarwalJanuary 13, 2020perception of risk, risk perception, risk perception factors, project manager resources, tips for project managers, tools for risk managementComment

Understanding Risk Management Requirements in ISO 13485:2016

The current revision of ISO 13485:2016 has new requirements for risk management. Here are some questions to consider and guidance for implementation.

Regulatory ComplianceNaveen AgarwalJanuary 10, 2020ISO 13485:2016, Risk Management, Risk management for medical devices, understanding risk management, quality management system, quality management system for medical devices, risk-based approachComment

The Softer Side of Risk Management

Everyone feels differently about risk. In this video presentation, we explore how individual perceptions influence risk analysis and decisions.

Risk ManagementNaveen AgarwalNovember 22, 2019risk perception, video presentation, risk management video, perception of risk, risk factors, risk perception factors, risk culture, effective risk-based decisions, medical device safety, bias of riskComment

How FDA is Shaping a Regulatory Policy for Device Cybersecurity

Updated draft guidance provides recommendations for design, labeling, and premarket documentation. Industry response points to a long road ahead before it can be finalized.

Regulatory ComplianceNaveen AgarwalNovember 20, 2019FDA medical devices, FDA guidance, regulatory policy, regulatory news, device cybersecurity, medical device security, medical device cybersecurity, FDA safety, FDA regulation, WannaCry ransomware attack, WannaCry ransomware, URGENT/11, healthcare, cyberthreats in healthcare, healthcare securityComment

A Pathway to Faster FDA Approvals

FDA is expanding the Abbreviated 510(k) Program with a Safety and Performance-based Pathway for certain medical devices.

Regulatory ComplianceNaveen AgarwalOctober 15, 2019FDA, FDA approval, FDA regulation, FDA program, Abbreviated 510(k) Program, medical devices, medical device approvals, FDA medical devices, FDA regulations, medical complianceComment

How to Avoid a Warning Letter from the FDA

A frequent reason for FDA warning letters is an inadequate corrective action plan to form-483 observations. When it is related to risk management, you need to dig deeper.

Regulatory ComplianceNaveen AgarwalOctober 2, 2019FDA warning letter, FDA guidance, FDA regulation, FDA draft guidance, Risk management for medical devices, form-483Comment

A New FDA Guidance Encourages Development of Safer Medical Devices

FDA has issued a draft guidance on the Safer Technologies Program (STeP) for Medical Devices to promote expedited development and regulatory review of safety innovations. This is certainly a STeP in the right direction!

Regulatory ComplianceNaveen AgarwalSeptember 20, 2019FDA, FDA regulation, FDA guidance, Medical device safety, FDA safety, safer technologies program, medical device safety action planComment

A Risk Management Tool for MedTech

Objective classification of adverse events has been a challenge for the industry. An outcome-based, medically-focused classification framework offers a more robust approach.

Risk ManagementNaveen AgarwalSeptember 11, 20195-point grading scale, clavien-dindo classification, medtech, risk management surgery, surgery, medical device, medical safety, medical risk management, surgical complicationsComment

Understanding ISO 13485:2016

ISO 13485 was revised in 2016 with several new requirements and a stronger emphasis on risk and planning. In fact, the older 2003 version did not define the term “risk” under Terms and Definition (Clause 3). A considerable amount of detail is now provided to clarify the concept of risk, which pertains to safety or performance requirements of the medical device or meeting applicable regulatory requirements within the scope of the revised standard.

Regulatory ComplianceNaveen AgarwalAugust 20, 2019quality system regulation, quality management system, ISO 13485:2016, exclusion, non-applicabilityComment

Cybersecurity is the Next Frontier of Risk Management

As medical devices increasingly become more interconnected with other devices, hospital networks and even smartphones, cybersecurity risks are quite real. Managing these risks is a product life cycle issue because they are continually evolving and may arise due to circumstances not completely foreseen during their development.

Risk ManagementNaveen AgarwalAugust 5, 2019cyber security, medical device, medical device safety, medical device cybersecurity, FDA safety, medical device recallsComment

Lifting the Curtain on Alternate Summary Reports

All ASR data files going back to 1999 are now available on FDA’s website. It is a large data set with over a million individual reports of device related injuries and malfunctions. We have started looking into this data and plan to provide insights that will help all of us better understand this information.

Risk ManagementNaveen AgarwalJuly 15, 2019Alternate Summary Reports, ASR Program, ASR program data, FDA ends ASR, Summary reports, medical device, medical device reportsComment

FDA Recognizes It's Time for QSR 2.0

FDA first announced its intention to “harmonize and modernize” the Quality System Regulation (QSR) for medical devices in Spring of 2018. The idea is to modernize the regulatory framework and harmonize the requirements with the newly revised ISO 13485:2016, the international standard for medical device quality management systems.

Well, it’s about time!

Regulatory ComplianceNaveen AgarwalJune 20, 2019risk management, FDA regulation, safety, medical safety, patient safety, quality system regulation, qsrComment

Can Your Risk Management Prevent a Recall?

Even if you have not had a recall, or your products are not in the top medical specialties cited in this article, there is a good chance your Quality Management System (QMS) is also vulnerable to deficiencies in these areas.

Risk ManagementNaveen AgarwalJune 12, 2019FDA regulation, safety, medical safety, patient safety, Class I Recall, Medical Device RecallsComment

When a Warning Fails

A warning letter is the agency’s way of giving you a final chance. Behave, or you will face painful enforcement actions such as a recall, seizure, civil money penalties, or worse still, jail time for responsible individuals. It carries a big stick, and predictably, manufacturers have been quite fearful of receiving a warning letter.

Regulatory ComplianceNaveen AgarwalMay 7, 2019risk management, FDA regulation, safety, medical safety, patient safetyComment

Achieving Excellence in Medical Device Benefit-Risk Assessments

Medical devices save lives, but they are not without risk. Whether it is a disposable soft contact lens used on a daily basis, or an intraocular lens surgically implanted to treat cataract, use of medical devices can potentially result in serious injury or even death. There are thousands of medical devices on the market, but there are also reports of millions of injuries and thousands of deaths associated with these devices in the last 10 years.

Risk ManagementNaveen AgarwalApril 22, 2019FDA regulation, safety, medical safety, patient safetyComment

Regulatory Policy in the Age of Artificial Intelligence

Artificial intelligence (AI) based devices are unique in their ability to learn from real-world use and experience, which can translate to rapid improvement in performance and new applications. In a sign of recognition of this capability, the FDA is proposing a new regulatory framework for review and approval of modifications to these devices after they have been cleared or approved.

Regulatory ComplianceNaveen AgarwalApril 9, 2019regulatory compliance, regulatory policy, artificial intelligence, artificial intelligence in healthcare, FDA regulationComment

FDA Finalizes the Guidance on Least Burdensome Provisions

Congress first added the Least Burdensome provisions to the Food, Drug and Cosmetics Act (FD&C) through Food and Drug Administration Modernization Act (FDAMA) of 1997. Additional provisions were added through the FDA Safety and Information Act (FDASIA) in 2012 and the 21st Century Cures Act (Cures Act) in 2016.

Regulatory ComplianceNaveen AgarwalMarch 11, 2019Least Burdensome, risk managementComment

The Real Goal of Medical Device Safety Surveillance

A defibrillator that locks-up after delivering the first shock causes delay in treatment which can result in serious injury or death. A needle-free closed system used to deliver chemotherapy drugs could release tiny plastic particles in a patient’s blood stream which can cause blockage. A pacemaker fails due to an unpredictable circuit error which can result in a life-threatening situation. These are just a few examples of Class 1 recalls recently announced by the FDA in a span of just a few weeks.

Risk ManagementNaveen AgarwalMarch 5, 2019Medical Device SafetyComment