Regulatory & Compliance Perspectives
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FDA’s Grace Period For Medical Device Cybersecurity Is Over. Are You Ready?
9/18/2023
The FDA had established a grace period for all medical device manufacturers to ensure that you are incorporating cybersecurity during the design and validation of cyber devices. The end date of the grace period, and the seminal date in medical device cybersecurity enforcement, is Oct. 1, 2023. Are you prepared?
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A Brief Guide To ISO 13485’s Design Controls In Medical Device Development
9/15/2023
Design controls play a crucial role in the medical device development process by providing a systematic approach to manage risks, design requirements, and verification and validation activities. Let's explore the key elements of ISO 13485 that will help you manage the process effectively.
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Your Best Chance At Regulatory Compliance For Combination Products: Integrated Development
9/14/2023
The FDA now defines a prefilled syringe, a product that was at one point considered “packaging” for a drug, as a constituent part of a combination product. The ultimate combination of the drug, its package, and its delivery device means that during development and manufacturing you need to combine both drug and device current good manufacturing practices (cGMPs) and quality approaches.
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The Landscape For Conducting Medtech Clinical Trials In The Dominican Republic
9/11/2023
The Dominican Republic, a Caribbean nation with over 11 million people, is experiencing an upward trend in attracting medical device clinical trials. Let's look at how its healthcare system is constructed, as well as advantages and challenges of conducting medtech clinical research in the country.
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5 Best Practices For Responding To FDA Form 483 Inspection Observations
9/1/2023
How you respond to FDA Form 483 observations will determine if they escalate into more serious consequences, such as a warning letter or enforcement action. You don't want that. Follow this 5-step action plan to make sure the findings are properly addressed.
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Korean GMP: MFDS Requirements For On-Site And Document Audits of Medical Device Manufacturing Plants
8/8/2023
If your medical device or in vitro diagnostics company is looking to enter the South Korea market, you will need to comply with the Korea Good Manufacturing Practice (KGMP) standards and requirements. This article shares a thorough overview of the requirements, including new information about audits that went into effect at the beginning of 2023.
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Agile Software Development In Bio/Pharma & Medical Devices, Part 3
7/25/2023
Computer software/systems validation testing are used to validate software under GxP environments. Parts 1 and 2 of this article series shared Agile methodology with regard to the phases of planning, team structure and collaboration, software architecture, and more. In this final installment, the author discusses software release, configuration and change management, CAPA, and more.
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5 Key Factors To Gain Regulatory Approvals for Innovative Rapid Diagnostic Devices
7/24/2023
COVID-19 demonstrated the power of rapid diagnostics on a global scale, but the path forward is still complex for in vitro diagnostics (IVD) developers and medtech leaders. This article outlines five factors to consider in order to enable efficient, smooth regulatory approval of your product.
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Agile Software Development In Bio/Pharma & Medical Devices, Part 2
7/11/2023
Part 1 of this article series dived into the use of Agile methodology with a focus on the planning phase of a software development plan. This article dives further and discusses the phases of team structure and collaboration, defining requirements and product definition, software architecture, and more.
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Key Takeaways From The EU MDR Expert Panels’ First Published Scientific Opinions
7/10/2023
The EU's Medical Device Regulation, which entered into force in 2021, introduced new requirements for clinical and post-market data for medical devices in Europe. As an additional level of scrutiny for specific devices, the Clinical Evaluation Consultation Procedure ensures that notified bodies correctly assess the clinical data. Let's look at what we can learn from the expert panels' first published scientific opinions.