Recent feedback from several regulatory agencies has demonstrated increased scrutiny of medical devices for aflatoxins and other chemical species in the Cohort of Concern (CoC). At Jordi Labs, we’re offering new ideas on how to best manage this scrutiny of medical device E&L. The white paper and case study feature detailed information on: Aflatoxin detection […]
Successful surgical device development is dependent on teasing out, sometimes unknown, needs and is best achieved through direct contextual research. This is especially true for devices to be used within the acute environment of the operating room. With the emergence of robotic technologies, the dynamics within the operating room is changing. In robotic surgery, there […]
Plan now to ensure your medical devices comply with new EMC requirements by the December 2018 effective date. Since the development cycle can be 2-3 years, it is important to understand the new IEC 60601-1-2 EMC 4th Edition standard now when designing medical devices. To provide you guidance on these important changes and improve your […]
When OEMs prepare to increase production volume of a micromolded component, many focus on multi-cavitation tooling as a strategy to reduce piece part price. While increasing cavitation may be a cost-effective approach for higher volumes of simple thermoplastic parts, it is typically not the best approach for micromolded parts, especially those that are bioabsorbable, or […]
Drug delivery devices constitute one of the most rapidly growing segments of the medical device manufacturing market. Makers focus substantial R&D efforts on designing delivery mechanisms for new and existing drug formulations. However, even good initial designs can’t guarantee that all the parts for these devices can be manufactured correctly and assembled consistently, with few […]
Establishing a sales certification program is not simple or cheap, and few companies do it well. This whitepaper dives into 7 elements of a successful sales certification program which include: Enabling sales reps a platform for perfecting their delivery Certification without the challenges of logistics or connectivity Sharing best practices & objection handling Leveraging this […]
The medical micro molding industry is still fairly young, but is rapidly growing and evolving. Being aware of shifts in trends and changes in technology helps to see where and how the next major innovations and breakthroughs will occur. In the medical device world, it’s often the smallest parts that carry the greatest importance relative […]
As medical device OEMs know, a product designed for the medical market is fundamentally different from one intended for industrial use. This is also true for a foot control. From the bottom pads to the mating connector, the design requirements for a medical-grade foot control are significantly different from those of an “industrial-grade” unit.
The rise of a SMART and connected world brings many challenges, especially as technologies continue to develop and evolve. The evolution of medical devices is no different. With more and more wireless medical devices hitting the market, the need for effective cybersecurity to safeguard patient data and ensure device functionality is critical. Manufacturers must integrate […]
If you’re considering a manufacturing transfer, you may be losing sleep over all the things that could go wrong: cost overruns schedule slips quality issues, to name a few. Missteps anywhere in the process can make the difference between meeting or missing your timeline and budget.
Speed your medical devices to market with this complimentary guide which takes you step by step through the process of submitting your medical devices for approval from the FDA. As a leader in third party testing and certification, Intertek’s industry experts developed this guide to simplify the complex process to submit your medical devices to […]