Join us as we explore groundbreaking innovations and discuss the critical role of regulatory compliance in advancing healthcare through cutting-edge technology.
Explore innovative strategies for Software as a Medical Device (SaMD) development, focusing on risk management, regulatory compliance, and cutting-edge architecture to ensure safety and effectiveness in healthcare.
Accelerate medical device market entry while ensuring quality and compliance. Discover how AI, innovation, and streamlined processes can help you balance speed with safety and regulatory standards.
In a world where healthcare disparities persist, the development of affordable medical devices and the expansion of telemedicine offer promising solutions. This article delves into how leveraging existing technologies and creating culturally adaptive interventions can make healthcare more accessible and equitable for underserved communities. Discover the impact of cost-effective medical innovations on reducing economic and cultural barriers to quality care.
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This article delves into Failure Mode and Effects Analysis (FMEA), offering insights into its methodology, application in medical device development, and its role in identifying and mitigating potential risks to ensure product safety and reliability.
Exploring the significance of IEC 60601-1 standards in medical device design, this article elucidates its pivotal role in ensuring electrical safety, performance, and compliance with international regulations, safeguarding both patients and healthcare professionals.
Navigating the MAUDE (Manufacturer and User Facility Device Experience) database, this article sheds light on its importance as a resource for tracking adverse events and safety issues related to medical devices, aiding in post-market surveillance and regulatory decision-making.
This article discusses the influence of RoHS and REACH regulations on medical devices, emphasizing their role in ensuring product safety, environmental responsibility, and regulatory compliance.
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.
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.
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.
