Industry Perspectives

41. 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.

42. 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.

43. Materials Innovation: Propelling A New Era For Medical Devices 7/19/2023

    Medical device designers are increasingly challenged by the limits of what the materials at their disposal can do. How can device manufacturers begin to consider what the alternatives to standard materials might allow for in a given medical application? And what would that process look like?

44. Biocompatibility Testing Tips To Speed Your Medical Device To Market 7/12/2023

    Biocompatibility testing is a regulatory safety requirement that assures a device and its components are compatible with the biologic environment in which the device will be used. Maintain your critical path to market with these tips.

45. Beat Your Medtech Competition To Market Launch With Streamlined Processes 7/11/2023

    With rampant competition in the medtech market, streamlining development processes lies in the ability to compress timing while maintaining the integrity of the final product. Let's look at how to do this.

46. Steps To Develop A Leak Test For Implantable Medical Devices 7/7/2023

    If you're developing an implantable medical device, you need to prove to regulators that it will function safely and effectively 10 years after implantation. However, there is no standard approach to follow, and before setting acceptance criteria, you'll need to find a way to test for leaks. Here is one effective method.

47. Key Considerations In Selecting A Robotic Solution For Endotoxin Testing 7/6/2023

    The U.S., European, and Japanese Pharmacopoeias require testing for bacterial endotoxin in pharmaceutical products, water, intermediates, and medical devices. This article shares key criteria for those of us who are looking to select an automated/robotic endotoxin detection system.

48. Optimizing CMO Partnerships 7/5/2023

    SMC experts discuss best practices and tips across a range of topics, including program management, automation, and secondary services.

49. A Practical Look At Data Governance In The Life Sciences 6/13/2023

    Without solid data governance, there is an increased risk of data discrepancies, misinterpretation, or even loss, which can hamper the development process. But what exactly is data governance? This expert shares a handy list of key considerations and strategies for moving forward.

50. All You Need To Know About Contamination Control Strategies, Part 2 5/22/2023

    In the second of this two-part series, microbiology and contamination control specialists Vanessa Figueroa and Greg Gibb continue discussing best practices in contamination control strategies through the lens of the newly formalized provisions in the EU GMP Annex I. Discussion includes the elements typically found in a CCS, who in your company is responsible for developing the CCS, how often it needs to be evaluated, and more.