Industry Perspectives

51. A Brief Introduction To Environmental Monitoring For Startups 11/17/2023

    Environmental monitoring is a crucial part of the pharma, biotech, and medical device field to indicate that the microbial particulate content of all cleanroom air and work surfaces is below acceptable levels. For new startups with a small number of employees wearing many hats, you might not have a deep understanding of what kind of monitoring is available, so this article shares an introduction.

52. Drug Delivery Systems: Measurement System Analysis Using Continuous Gage R&R Studies, Part 2 10/27/2023

    This article, part 2 of a 3-part series, examines the prerequisites phase, development and approval of the study protocol phase, execution sequence, and post-execution of a continuous gage repeatability and reproducibility (R&R) study for drug delivery system measurement system analysis.

53. Drug Delivery Systems: Measurement System Analysis Using Continuous Gage R&R Studies, Part 1 10/6/2023

    All drug delivery manufacturing systems undergoing quality improvement projects involve teams to gather many inputs and then to analyze the data. This article, the first in a 3-part series, provides an overview and theoretical understanding of measurement system analysis using continuous gage repeatability and reproducibility (R&R) studies.

54. 5 Smart Manufacturing Strategies For Medical Device Startups 9/28/2023

    Large medical device companies with deep pockets can afford to employ technology and automation. Startups have to think differently and need to employ true strategic thinking and careful decisions. This article outlines five smart manufacturing strategies that will benefit medical device startups.

55. EU Medtech Labeling Compliance & The Competitive Advantage Of A Digitalized Process 9/26/2023

    In the medtech industry where time and regulatory compliance are crucial, optimizing and digitalizing your labeling processes are essential for bringing medical devices to market quickly and play a vital role in keeping products available to patients and healthcare providers in the EU.

56. 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.

57. 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.

58. 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.

59. 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.

60. The Critical Role Of Risk Mitigation & Vertical Integration In Successful Micro Molding 7/31/2023

    In this exclusive Q&A article, Alex Anderson, Sales Engineer at Accumold, systematically explores the crucial implications of vertical integration in micro molding projects.