Join us as we explore groundbreaking innovations and discuss the critical role of regulatory compliance in advancing healthcare through cutting-edge technology.
Discover the complexities of Class III medical devices, the highest risk category regulated by the FDA. This comprehensive guide delves into their classification, regulatory pathways, and development challenges, ensuring manufacturers and healthcare professionals understand the critical role these devices play in patient care and safety.
Explore the unique functions and regulatory landscapes of In Vitro Diagnostic (IVD) devices and medical devices. Understand their roles, FDA classifications, and the stringent standards ensuring safety and efficacy in healthcare technology.
Discover the five key stages of innovative medical device development, from concept ideation and prototyping to regulatory compliance and manufacturing, ensuring quality, safety, and market readiness.
Become part of a community of over 10,000 medical device professionals who are driving healthcare forward through innovation.
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This article explores the 510(k) process for medical devices, detailing its significance, requirements, and implications for regulatory clearance in the United States, offering insights into navigating this crucial pathway for market approval.
This article provides an overview of the Medical Device Single Audit Program (MDSAP) framework, highlighting its significance and benefits in streamlining regulatory compliance across multiple jurisdictions for medical device manufacturers.
This article explores aluminum’s biocompatibility in medical and industrial applications, highlighting its suitability, benefits, and considerations for use in various contexts, offering valuable insights for engineers and designers.
This article explains the importance of Nectar’s ISO 13485:2016 certification, ensuring quality management in medical device design and development to meet strict regulatory standards for safe and effective products.
Before you even reach the FDA approval stage, there are a few things you should keep in mind as you run through the medical device development process.
Electromagnetic Interference (EMI) arises when electronic devices encounter electromagnetic fields. EMI affects any gadget with electronic circuitry, and its significance grows with the proliferation of complex electronic devices.
This article delves into user interface design’s significance in medical device development, highlighting its crucial role in ensuring usability, safety, and user satisfaction, offering valuable insights for engineers and designers aiming to create effective and user-friendly medical devices.
Having an idea for a medical device that can change the world is great, but is only the beginning. Make sure you understand the regulatory requirements.
There is one crucial team member in the development process who can help ensure ultimate project success: the Systems Engineer.
The healthcare sector is undergoing a profound transformation with the advent of the Medical Internet of Things (Medical IoT) within the rapidly expanding realm of the Internet of Things (IoT).
This article emphasizes the vital role of human factors validation and usability testing in medical device development, ensuring safety, effectiveness, and user satisfaction.
Plan for an effective design transfer process to successfully transfer your product into a viable manufactured good that can pass quality assurance tests.
Darren is an accomplished, dynamic leader who founded Nectar, X-Naut, and BreathDirect. He is committed to improving the world through the synthesis of technology, science, and art. Under Darren’s leadership, Nectar is leveraging the latest advances in cutting-edge technology to transform medical device development and design. As part of his
Dr. Steve Wells holds a critical role in steering Nectar’s operations and defining its strategic direction. His impactful leadership has established a clear course for the company’s success. He has revitalized the company with a passion for maximizing impact through expert resource utilization since taking the helm in 2020. Steve has boosted Nectar’s portfolio, streamlined processes, and reinvigorated its innovation agenda, all with the goal of developing life-saving and impactful products. His background in senior leadership roles at Georg Fischer and his people-focused, results-driven leadership style make him an invaluable asset to our team. Steve’s extensive knowledge in chemistry, biocompatibility, and biology only adds to his value as a team member.
Adam Marten has worked in the aerospace and consumer products industries since 2006 with lead engineering experience in conceptual design, product development, analysis and performance qualification testing. Adam has experience leading a range of technical projects, including multiple structural analyses for military and aerospace applications. He has also worked directly with engineering teams to develop medical devices and laboratory instrumentation.
With over two decades of experience in healthcare innovation, Kerry has been instrumental in transforming patient care and improving patient outcomes across the globe. Her extensive knowledge and expertise in the cardiovascular and cardiothoracic operating room, as well as her experience in emergency medicine, geriatrics, pediatric psychiatry, and main OR, make her a versatile and valuable member of the team. From small hospitals to large teaching institutions, Kerry’s 20 years of experience with patient documentation, including the use of EPIC, Cerner, and Meditech electronic charting systems, have positioned her as a leader in her field. Her recent involvement in helping transition the Providence St. Vincent Medical Center’s Cardiac Surgery program from paper charting to electronic documentation further underscores her commitment to advancing the healthcare industry.
