Regulatory Articles

61. 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.”  

62. 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.

63. 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.

64. 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. 

65. Medical Device Registries: Recommendations For Advancing Safety And Public Health 8/12/2015

    Recent high-profile failures of medical device technologies, including metal-on-metal hips and implantable cardiac defibrillators, are a reminder that this country lacks a robust system for assessing the safety and effectiveness of medical devices once they enter the market.

66. Cleanliness Validation For Medical Devices 8/12/2015

    Residues on the surface of medical devices can cause implant failure and poor device performance. The main source of these residues is from materials used in the manufacture of the device, although contamination during the storage, cleaning and handling of the device is also known to occur.By Chris Pickles, Ph.D.

67. UDI Impact on Medical Device Labeling: Lifting The Lid On Pandora's Box 7/24/2015

    Medical device companies are striving to capitalize on market opportunities while simultaneously dealing with increasing regulatory compliance requirements. One of the newer mandates, the FDA ruling on Unique Device Identification (UDI), requires action in three main areas.

68. Beyond Compliance: Medical Device Product Development 7/24/2015

    Increased regulatory scrutiny is a reality in today’s medical device industry. Over the last several years many of the industry’s leading companies have been hit with an injunction, undergone a product recall, or found themselves operating under FDA consent decree. At the same time, the pressure for growth on these companies has never been greater. Driven by Wall Street, the pace of new technology, emerging market opportunities, and competition from well funded start-ups, medical device executives find themselves in an environment where they must continually innovate with flawless execution to survive.

69. CYA 101: 4 Tips to Help You Cover Your Audit 7/23/2015

    Audits are a part of doing business for most life sciences companies, but that doesn’t make them any less stressful. If an audit goes badly, it’s a black eye for your company. You could be looking at long product delays, warning letters, consent decrees, recalls, or even a plant shutdown. So, what’s the secret to walking into an audit with confidence? It takes proper planning and the right tools. Here are a few tips to help you be better prepared, so you no longer have to fear the auditor.

70. Due Diligence On Your Medical Device Manufacturing Partner 7/10/2015

    A number of healthcare market forces – from cost pressures and global competition to strong demand from emerging nations – have converged to drive increasing use of design & manufacturing services companies to design, engineer, manufacture, package and distribute a wide range of medical devices.