Articles From Our Expert Network
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7 Rules For Properly Interpreting Control Charts
2/15/2021
It is time to consider augmenting your validated production processes, including processing, packaging, and labeling, with continuous process monitoring using control charts to ensure continued compliance with established specifications and requirements.
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Germany’s Digital Medical Device Regulations: A Framework For The World To Follow, Part II
2/12/2021
Germany's BfArM, or the Federal Institute for Drugs and Medical Devices, released a new guide in August 2020 detailing the requirements for digital health application manufacturers in order to make your DiGAs available to the more than 73 million participants in the German statutory health insurance, and other countries will likely follow in its footsteps. In Part II of this three-part series, John Giantsidis of CyberActa, Inc. examines the data security requirements.
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ISO 14971:2019 — Clarifying Benefit, Risk, & Benefit-Risk
2/8/2021
This is the third in a series of articles on the changes in the medical device risk management standard ISO 14971 that were released in Dec. 2019 and supported by guidance in the ISO TR 24971:2020 technical report or guidance. This article by Edwin L. Bills, member of ISO TC 210 JWG1, covers the change in the process for benefit-risk covered in Clause 8 of the standard.
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Top 3 Trends Affecting The Dental Implants Market In 2021 And Beyond
2/3/2021
Dental implants have increasingly become the preferred treatment for edentulous individuals as practitioner expertise and supporting technology around dental implants continue to advance. William Guo and Kamran Zamanian, Ph.D., of iData Research Inc. delve into the three trends driving the growth of this market.
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An ISO 14155:2020 Primer — Good Clinical Practice For Medical Device Trials
2/2/2021
An analysis of the recently released ISO 14155:2020, "Clinical investigation of medical devices for human subjects — Good clinical practice," a standard developed to guide clinical research professionals during the design, conduct, recording, and reporting of clinical trials related to the safety and effectiveness of medical devices.
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Germany’s Digital Medical Device Regulations: A Framework For The World To Follow, Part I
1/29/2021
Germany's BfArM (the Federal Institute for Drugs and Medical Devices) released a new guide in August 2020 detailing the requirements for digital health applications, and other countries will likely follow in its footsteps. John Giantsidis, president of CyberActa, Inc., gives an overview of the situation and will cover the many privacy requirements noted in the new guide in Part 1 of this three-part article series.
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Avoiding ISO 14971 Mistakes — What Does “Harm” Really Mean?
1/27/2021
In the first two parts of this three-part series on ISO 14971 terminology, we discussed the terms “hazard” and “hazardous situation” in detail. In this third and final part, we will review the term “harm,” provide examples to illustrate how you can define potential harms applicable to your medical device, and explain how you can link them to relevant hazards and hazardous situations.
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With Release Of New Guidance Document, FDA Launches Safer Technologies Program for Medical Devices
1/25/2021
The FDA’s Center for Devices and Radiological Health (CDRH) released the Safer Technologies Program for Medical Devices (STeP) Guidance for Industry and Food and Drug Administration Staff on January 6, 2021, with plans to begin accepting applications for STeP beginning March 8, 2021. Is this a good fit for your medical device or device-led combination product?
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Closing The Loop On Risk Management With ISO 14971:2019
1/22/2021
Edwin L. Bills, member of ISO TC 210 JWG1, discusses the evolution of risk management standards for medical devices and how ISO 14971:2019's revision (which is also identical to EN ISO 14971:2019) is meant to "close the loop." Based on the extensive changes in Clause 10, all manufacturers of medical devices and in vitro medical devices will need extensive review and possible changes to their production and post-production activities section of their quality systems in order to meet the new requirements.
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Avoiding ISO 14971 Mistakes — Are You Accurately Defining “Hazardous Situations”?
1/20/2021
There is a lot of confusion and inconsistency in the implementation of risk management systems to meet the requirements of ISO 14971. In the first part of this three-part series, we discussed the term “hazard” in detail. In this second part, we will review the term “hazardous situation” and provide examples to illustrate how you can define potential hazardous situations during risk analysis of your medical device.