Industry Perspectives

41. Best Practices Handling Material Changes For Medical Devices 3/18/2024

    Despite the best intentions of procurement, suppliers may impose changes in the availability of material grades. Have a process for controlling and mitigating the effects of material changes in order to reduce risk and avoid interruption.

42. 2024 LIMS Trends 3/15/2024

    The laboratory information management system (LIMS) landscape in 2024 is a dynamic one, driven by accelerating advancements in technology and evolving industry needs. This article shares the four key trends.

43. The 10 Most Frequently Asked Questions On Glass: Part 2 2/20/2024

    Read the second part of this series on the most common questions encountered by an expert focused in scientific affairs and technical solutions for glass.

44. A Data-Derived Approach For Selecting Criticality Levels In FMECAs For Cleaning Process Risk Analysis 2/16/2024

    The ASTM E55 Cleaning Team, in collaboration with F04 Medical Device Committee members, felt that the commonly used three-level criticality system was inadequate for use in a science- and risk-based standard for cleaning process development, validation, and monitoring. This article will provide a detailed discussion of how science-based and data-driven criticality levels were derived, the meaning of each level, and how they can be used for guiding the selection of risk reduction and risk control measures.

45. Using Relational Risk Analysis To Control Procedure Failures 2/15/2024

    In the bio/pharma and medical device industries, operating procedures guide virtually every activity and are required for compliance with good manufacturing practices. Minimizing procedure execution failures is critical. To do so, you can use relational risk analysis (ReRA).

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 Decoding The FDA's Draft Guidance On Computer Software Assurance For Medical Devices & Bio/Pharma 2/6/2024

    In 2022, the FDA released a draft guidance on computer software assurance that promises to reshape the validation of automated data processing system and quality system software in the pharma/medical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.

47. Drug Delivery Systems: Measurement System Analysis Using Continuous Gage R&R Studies, Part 3 12/20/2023

    This is the third article in a series of three articles. It continues the discussion of measurement system analysis using continuous gage R&D studies by sharing a generic example using Minitab. Study setup, the role of the study director, analysis, and case studies are examined.

48. WHO's 6 Principles For An AI Regulatory Framework For Medical Product Development 12/14/2023

    In mid-Oct. 2023, the WHO published a paper titled Regulatory Considerations on Artificial Intelligence for Health, identifying the key principles that international regulatory frameworks for artificial intelligence (AI) should address and are, in fact, starting to coalesce around. The paper was developed in consultation with a WHO Working Group whose members include regulatory authorities, policy makers, and more.

49. Key Considerations In "Intended Use" And "Indications For Use" Statements For Medical Devices 12/14/2023

    You are familiar with the terms “intended use” and “indications for use.” But not everyone understands exactly what they mean, how they are different, and how they are used. It's critical for the successful development, regulatory approval, and reimbursement of your device.

50. Introduction To The New ASTM E3418, Standard Practice For Calculating Scientifically Justifiable Limits Of Residues For Cleaning Of Pharmaceutical And Medical Device Manufacturing Equipment And For Medical Devices 12/11/2023

    The ASTM E55 Cleaning Team has developed and balloted a new standard practice for calculating safe and scientifically justifiable limits for residues found after cleaning processes. This is the first comprehensive guide to setting limits for use in cleaning validation that includes all types of chemical residues, bioburden residues, endotoxin residues, and visual residues.