Regulatory & Compliance Perspectives

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. Combination Product QMS Requirements For The EU Market 6/30/2023

    Pharma companies are now building the capability to manufacture combination products in-house to increase flexibility and reduce dependency on third parties. This article shares key considerations for companies implementing a medical device QMS with regard to EU requirements.

  8. Agile Software Development In Bio/Pharma & Medical Devices, Part 1 6/27/2023

    Under the FDA and other regulatory bodies, the bio/pharma and medical device industries have been using computer software/systems validation testing methodologies to validate software within the GxP environment. Let's dive into the use of Agile methodology in the planning phase of a software development plan.

  9. An Agile Approach To Regulatory Information Management System Transformation 6/20/2023

    Life sciences industry regulators have become increasingly focused on data-driven processes as a means of managing marketing authorization submissions. But this requires that your regulatory information management system (RIMS) upgrades are in a state of continuous evolution and are approached holistically. 

  10. The Business Case for Healthcare Compliance Programs for Emerging Companies 6/9/2023

    For emerging drug and medical device companies on a tight budget, an effective healthcare compliance program can actually save precious resources by establishing better oversight, controls, and monitoring of the company’s quality, R&D, clinical, and market access activities. Such a program should be implemented in pre-commercial stages and will prepare you for the regulated future ahead.