Recognizing that their traditional approach to moderate and higher-risk, hardware-based medical devices is not well suited for the more rapid and iterative design, development, and validation phases used for software products, the FDA has created a new Digital Health Innovation Action Plan. One important piece of this plan is the “Software Pre-Certification (Pre-Cert) Pilot Program”. This pilot program, which began on September 1, 2017, is a voluntary program that will enable the FDA to develop a tailored approach toward regulating digital health technologies by looking first at the software developer and/or digital health technology developer, rather than the product. The purpose of this is to streamline the regulatory process for companies with a history of developing and testing quality products. Once pre-certified, that developer would be empowered to make software iterations and changes as needed. The nine participants that have been selected for the Software Pre-Cert Pilot Program are Apple, Fitbit, Johnson & Johnson, Pear Therapeutics, Phosphorous, Roche, Samsung, Tidepool, and Verily. According to the FDA, these participants were chosen as they “represent a wide range of companies and technology in the digital health sector, including small startups and large companies, high- and low-risk medical device software products, medical product manufacturers and software developers.”
Read More →Additive Manufacturing in Medical Devices: Insights from J&J and the FDA
One of the promises of additive manufacturing is the ability to go after niche markets with low volume production of unique parts. What application could be more apt for this technology than the human body? Last month, the FDA issued a statement providing guidance to manufacturers on technical aspects of additive manufacturing, clarifying what the FDA recommends manufacturers include on submissions for 3D printed medical devices. The FDA has, so far, approved over 100 3D printed medical devices, including knee replacements, custom skull/facial reconstructions, and even a 3D printed drug, called Spritam, which is used to treat seizures. The FDA has categorized this technical guidance as a “leap-frog” guidance, explaining that it is just a mechanism to share initial thoughts in order to bridge where we are today with the innovations of tomorrow.
Read More →Are you struggling with finding a fully validated Requirements Management Tool?
“Validation is required, as regulated by FDA, to ensure that a company’s product development software/system will meet its intended purpose. The software/system must show that it will function in a reliable, consistent manner and is in compliance with regulatory and business requirements. Additionally, once the software/system has been accepted and released for use, there is a need to maintain compliance and fitness throughout its operational life. Unfortunately, information on how to develop a validation plan and the activities expected as part of a validation effort are limited and subject to misinterpretation.” Are you struggling with finding a fully validated Requirements Management Tool? If so, check out the full white paper by Cognition!
Read More →Industry Insights: Interview with Dr. Steve Levine, Dassault Systèmes
At Generis’ American Medical Device Summit 2016, we sat down with Dr. Steve Levine, Senior Director of Product Strategy and Executive Director of the Living Heart Project at Dassault Systèmes and discussed scientific innovation initiatives such as the Living Heart Project, realistic simulation, and technology’s role in the industry. Check out the full video below!
Read More →Top Medical Device Industry Regulations—and Why They Matter
It’s important to keep up with compliance mandates because the US Food and Drug Administration (FDA) keeps a close watch on the medical device industry. If there is an accident involving your devices, it could damage the lives of your patients and the reputation of your company. This article focuses on the most significant FDA quality regulatory programs to be aware of, and tips on how to avoid fines and court action for non-compliance. Read the full article here. For more information about keeping up with regulations, visit The Copley Consulting Group and Infor CloudSuite Industrial for Medical Devices.
Read More →Maetrics: The ROI of Good Quality & Compliance
On October 5th, 2016 at the American Medical Device Summit in Chicago, Generis welcomed Maetrics to the speaker panel on Day One. Ed Roach, the Managing Director of Maetrics, focused his presentation on four main objectives being: Ideas on how to quantify the costs of quality for investment justification Understanding indirect or potential costs of quality and compliance including Examining FDA’s recent and future approach to Medical Devices The Potential Impacts of FDA’s approach to Medical Devices Understand the Benefits of a Proactive Quality System Benchmarking – Good Investments in Quality and Compliance To view the full presentation online, click here. Panel Speaker: Ed Roach, Managing Director of Maetrics Ed Roach brings nearly 20 years of experience in the life sciences industry to the panel while adding his wealth of knowledge on Quality Systems and Quality Assurance, Validation, Corrective and Preventive Actions (CAPS), Root Cause Investigation, Change Management, and 483/Warning Letter Remediation to the American Medical Device Summit. Generis is thrilled that Maetrics will be returning to Chicago for the American Medical Device Summit on October 4th and 5th in 2017. For more information on Generis or our American Medical Device Summit taking place in 2017, please, don’t hesitate to contact us today.
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