Regulatory & Compliance Perspectives

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. MHRA UKRP Requirements For U.S. Med Device Companies To Enter The U.K. Market 7/5/2023

    The new European MDR is causing delays and complications for businesses wanting to place a new medical device on the European market. If you're considering placing your device on the UK market instead, here's what you need to know for appointing a UK Responsible Person to act on your behalf.