Regulatory & Compliance Perspectives

51. Understanding The New MHRA Requirements For Medical Devices In Great Britain 4/9/2024

    The U.K.’s MHRA has updated its transition arrangement dates for CE marked devices with regard to EU MDR compliance.

52. A Cost-Effective Approach To EU MDR Compliance 4/2/2024

    How can you be cost-effective in the face of the cost of compliance with the EU's Medical Device Regulation (MDR)? This article shares tips.

53. Colombia: A Strategic Choice For Medtech Clinical Trials 3/21/2024

    Colombia, one of the top three economies and most populous countries in Latin America, is a promising destination for medical device clinical trials for these reasons.

54. Navigating EU MDR Compliance: Overcoming Challenges To Sustain Your Certification 3/19/2024

    This article dispels the myth that obtaining EU MDR certification is an end point. The evolving landscape demands ongoing diligence to comprehend and adhere to changing requirements.

55. A Structured Approach To Regulatory Information Management Vendor Selection 3/13/2024

    Deploying a formal system for regulatory information management is a given now for all life sciences companies, irrespective of their size and focus. Regulators expect this, particularly as data rather than static documents evolves to become the default.

56. Notable Public Comments On The FDA's Proposed Regulation For Laboratory Developed Tests 3/12/2024

    The proposed FDA regulation for laboratory developed tests marks a significant step toward the FDA trying to standardize oversight for these diagnostic tools. As the FDA seeks public input, it is a hot topic as stakeholders grapple with the implications of increased regulatory scrutiny, debating its impact on patient access, innovation, and the overall landscape of diagnostic testing in the U.S.

57. 6 Things Medtech Companies Should Know About The EU's AI Act 3/4/2024

    With the recent publication of the European Union’s long-awaited Artificial Intelligence Act (AI Act), the message to medtech companies is clear: you need to move toward compliance by understanding your AI systems, determining their role under the AI Act, and identifying the specific obligations and implementation strategies that apply.

58. New FDA QMSR Through The Lens Of Risk Management: Requirements And Analysis 2/29/2024

    On Feb. 2, 2024, the FDA set a new cornerstone in the medical device regulatory landscape by releasing the new Quality Management System Regulation (QMSR), a forward step that is scheduled to be fully implemented by Feb. 2, 2026. Let's take a closer look, including the role of ISO 13485, expectations for compliance with ISO 14971, and more.

59. Understanding Australia's Regulatory Framework For SaMD 2/12/2024

    In 2021, Australia's Therapeutic Goods Administration implemented reforms covering a wide range of software, including software as a medical device (SaMD) with the goals of clarifying the scope of regulated software products, introducing new classification rules, and updating the principles governing software-based medical devices.

60. Decoding The FDA's Draft Guidance On Computer Software Assurance For Medical Devices & Bio/Pharma 2/6/2024

    In 2022, the FDA released a draft guidance on computer software assurance that promises to reshape the validation of automated data processing system and quality system software in the pharma/medical device industry and to enhance the quality, availability, and safety of medical devices. This article walks through the key elements of the guidance.