Content by Jon Speer
Three Tips For Incorporating Risk Management During Medical Device Product DevelopmentFix issues that expose you to risk when it’s less expensive and time-consuming

Thu, 10/13/2022 - 12:03
Medical device product development and risk management are often treated as entirely separate processes. Sure, there is usually acknowledgement and understanding that these two processes are related. But it is important to realize that product…
Quality Assurance vs. Quality Control in the Medical Device IndustryThe highest quality is a combination of the two
Tue, 06/07/2022 - 12:03
Imagine that your medical device malfunctioned during patient use. Do you know whether quality assurance or quality control is responsible? When working through remediation efforts, do you know which quality function demands the attention, or should…
Seven Project Management TipsHow project management complements product development
Tue, 11/23/2021 - 12:02
When I began my medical device career, I started as a product development engineer. Part of the role included—right, wrong, or indifferent—project management. And I’ve found throughout my career and from discussions with hundreds of others in the…
Closed-Loop Traceability for FDA ComplianceHow to do it in real time
Wed, 06/02/2021 - 12:01
Demonstrating identification and traceability in all quality system processes is a must for medical device companies to comply with FDA regulations. To satisfy this compliance need, companies will need to connect related processes within their…
How to Structure Your Medical Device Technical FileModern methods of documentation compliance
Tue, 05/11/2021 - 12:02
The medical device technical file is a must-have document for devices to be sold in the European Union (EU) marketplace. The file contains detailed information about your medical device, its design, intended use claims, composition, and clinical…
Unannounced AuditsA survival guide for medical-device quality managers
Wed, 11/18/2020 - 12:02
The medical device industry is one that requires preparation. Unlike less regulated industries, there’s an expectation in the industry around the possibility that an inspector or auditor can show up without notice and stop a business in its tracks…
Four Essential Processes in Medical Device Risk ManagementWhen failure is not an option
Tue, 09/29/2020 - 12:03
Risk can mean many different things depending on the situation. Flying on an airplane, biking on a busy road, driving in a car—all of these involve some level of risk. Although risk is a variable we encounter in everyday life, it means something…
The Importance of Managing and Controlling Risk in the Medical Device IndustryKnowing where to prioritize is key to successful mitigation
Tue, 09/08/2020 - 12:02
Imagine you’re a patient going in for any medical procedure. You probably think very little about the risks of the medical device being used on you. Generally, patients trust clinicians’ expertise and seldom wonder if the products being used have…
What You Need to Know for an Effective Risk AssessmentTwo concepts to ensure patient safety and device quality
Thu, 05/14/2020 - 12:02
Historically, risk management has been a complex and polarizing subject, with various stakeholders assigning different values on the probability and severity of harm. In the medical device industry, risk management’s high importance has led to the…
Three Myths Engineers Believe About QualityThere’s always a way for medical device engineers to create and focus on true quality
Wed, 04/01/2020 - 12:02
Successfully run medical device companies are cross-functional. From product development, manufacturing, quality, and regulatory compliance, to marketing and sales, every business operation works together to produce and sell medical devices that…