Regulatory Articles

51. Streamline Medical Device Compliance With Jama: How Jama Simplifies FDA Compliance By Improving Processes 2/8/2018

    Instead of focusing on FDA-regulation as the driving force in product development, compliance should instead be an outcome of a streamlined process that ensures a safe and reliable product is delivered to market. Achieving compliance, and creating the documentation, is an outcome of the focus and rigor required for regulated product development. This article discusses how Jama Software can simplify FDA processes by improving development and production.

52. OEMs: Do You Trust Your Medical Device Supplier's Quality? 8/1/2017

    As an OEM, it is your responsibility to ensure the parts supplied to you are compliant with ISO regulations. Ideally, your supplier’s quality systems are strong enough to identify risks, prevent defects, and to catch defects quickly if they do occur. This requires a robust quality management system. 

53. Managing The Unpredictability Of The Product Development Process 8/1/2017

    How development teams need to engage in the holistic, programmatic risk management necessary for a predictable development program.

54. Incorporating Stress Into User Testing 8/1/2017

    How do you design a usability test that mimics the panicked, stressful situation that a user may be in when he or she is using your medical device in the real world?

55. Are You Gambling With Medical Device Compliance? 1/5/2017

    OEMs can ease their burden of ensuring CMO regulatory compliance by selecting a CMO with a fully integrated system for DHR creation. Not only can such a system eliminate the inaccuracies of paper records, but it enforces documentation and automates error prevention.

56. Is Your Medical Silicone Molding Company FDA Ready? 8/17/2016

    The U.S. FDA and the European Commission (EC) have increased their surveillance on medical device manufacturers and their suppliers. This article discusses how to evaluate audit readiness for a medical silicone molding company, as well as preparing to move toward global quality standards.

57. Barcoding Standards And The Search For A UDI “Easy Button” 8/17/2016

    As the FDA’s next deadline for the unique device identification (UDI) of Class II devices draws closer, medical device manufacturing companies are looking to further their UDI implementation, whether they are well on their way to success or they haven’t even started. Barcoding, or identifying products via GS1 regulatory standards, is essential for companies wishing to be up to date on UDI implementation. Unfortunately, companies may be delaying UDI implementation because they view the new regulations as something an organization can address quickly. This is not the case. This article discusses the importance of viewing UDI implementation as process that encompasses the entire company rather than just as a “quick fix.”  

58. 7 Considerations For More Effective Medical Device Labeling And Overlays 7/14/2016

    Labels often are an afterthought, because they don’t directly affect the capabilities of a medical device. However, they certainly affect the functionality of the device and users’ ability to effectively utilize all of its features. Consider these factors — and their importance — as you design your medical device overlay or inventory stickers.

59. Assessing The FDA's Cybersecurity Guidelines For Medical Device Manufacturers 2/17/2016

    In practically all matters of cybersecurity within the health sector, the United States Food and Drug Administration (FDA) seems to be in a constant state of offering subtle suggestions where regulatory enforcement is needed. The argument against enforcing cybersecurity standards typically centers on the idea that a regulatory presence stifles innovation. Due to the industry’s continuous lack of cybersecurity hygiene, malicious electronic health record (EHR) exfiltration and vulnerabilities in healthcare’s Internet of Things (IoT) continue to be a profitable priority target for hackers.

60. Two Essential Steps To Protecting Your Global Supply Chain From UDI Disruption 10/2/2015

    For most medical device companies, compliance with the Class III FDA UDI final rule already has been addressed, and most project stakeholders probably have started to develop a compliance strategy for FDA UDI Class II. What UDI-impacted stakeholders may not be considering is how FDA UDI could impact their company’s global inventory management strategy. In this article, we provide two steps companies should take to ensure their global supply chain maintains continuous flow of product.