Join us as we explore groundbreaking innovations and discuss the critical role of regulatory compliance in advancing healthcare through cutting-edge technology.
Explore the critical link between compliance and safety in medical device labeling. Emphasizing regulatory adherence to ensure patient well-being and legal compliance.
Discover how lab-on-a-chip technology revolutionizes medical device design. Explore its miniaturization, portability, and advanced diagnostic capabilities shaping healthcare’s future.
Explore IPX ratings in medical device design with a detailed chart and analysis. Engineers, ensure compliance and protection against environmental factors.
Uncover MEMS’ impact on medical tech, revealing their precision and adaptability in revolutionizing healthcare via programmable electrical systems.
Discover the vital link between ISO 10993-1 and ISO 14971 standards in medical device design. Ensure safety and effective risk management across the product lifecycle.
Explore the pivotal role of formative evaluation in medical device development. Enhance usability, refine designs, and ensure regulatory compliance for safer products.
Exploring ISO 14155 standards for clinical investigations in medical device development, this article provides insights into ensuring ethical conduct, data integrity, and patient safety throughout the clinical trial process.
This article navigates the intricate landscape of IVDR (In Vitro Diagnostic Devices Regulations), shedding light on its impact on the medical device industry and emphasizing compliance measures to ensure product safety and effectiveness.
Delving into the realm of SAMD (Software as a Medical Device), this article explores its regulatory landscape, development challenges, and potential to revolutionize healthcare delivery through innovative digital solutions.
This article dives into the realm of biocompatibility in medical device engineering, exploring its critical importance, regulatory considerations, and methodologies for ensuring the safety and compatibility of devices with the human body.
Exploring the classification of medical devices, this article focuses on Class 2 devices, elucidating their regulatory requirements, risk levels, and examples within the healthcare landscape.
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.
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.
Exploring advancements in drug delivery combination devices, this article highlights their revolutionary impact on medical treatments, offering insights into improved efficacy, patient compliance, and therapeutic outcomes, paving the way for transformative healthcare solutions.
FDA Approval: Medical Device Regulations for Innovation and Patient Safety Navigating the extensive terrain of medical device
In the laboratory setting, the advent of AI has been nothing short of revolutionary. Instruments equipped with
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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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.
There is one crucial team member in the development process who can help ensure ultimate project success: the Systems Engineer.
Find some important human factors like Safety, Bias, Effective Design, and Product Assessment that help to create the best product designs. Read to know more.
The Nectar Product Development User Experience team participated in an IoT hackathon event at The Vine in Irvine, CA. That was a great learning experience.
Nectar Product Development’s sleek and modern designs for a line of consumer garden tools were awarded three 2011 GOOD DESIGN Awards.
Nectar Product development had a requirement for a small screen to display some data to the user. We had to figure out a quick way to prototype it.
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.
