Introduction to ISO 14155 As medical device manufacturers, ensuring the safety, credibility, and efficacy of our products
Introduction to In Vitro Diagnostic Devices (IVDD) In vitro diagnostic devices (IVDD) play a crucial role in
Introduction to SAMD (Software as a Medical Device) As technology continues to advance, the healthcare industry is
Introduction to Biocompatibility of Medical Devices Biocompatibility is a critical aspect of medical device development, as it
Understanding Classification, Regulatory Pathways, and Medical Device Exemptions The world of medical devices is multifaceted, and understanding
Introduction to FMEA Failure Modes and Effects Analysis (FMEA) is a systematic, structured approach used by organizations
Introduction to the IEC 60601-1 Medical Device Standard The IEC 60601-1 is a widely recognized international standard
Introduction to the Maude Database The field of medicine is constantly evolving, with new medical devices being
Introduction to RoHS and REACH regulations In today’s global marketplace, it is essential for businesses to understand
Project Management in Medical Device Development The development of medical devices is a multifaceted and tightly regulated
Introduction to the Medical Device Single Audit Program (MDSAP) The Medical Device Single Audit Program (MDSAP) is
Introduction to Aluminum Biocompatibility Aluminum, a versatile and widely used metal, has found its place in various
In episode 6 of The Product Development Playbook, we delve into the critical aspects of commercialization, branding,
The International Organization for Standardization (ISO) have established standards for quality and risk management of materials and processes. Learn more.
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.
User Interface: What is it, and why is it important for medical device development? In the rapidly
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.
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.
Navigating the complex waters of medical device development is akin to setting sail on an exciting but
Seek guidance from Shannon McElfresh-Hall, Nectar Product Development’s Director of Operations, on the qualities the company seeks in engineering graduates.
Introduction to Human Factors Validation and Usability Testing in Medical Devices Understanding the crucial role of Human
Plan for an effective design transfer process to successfully transfer your product into a viable manufactured good that can pass quality assurance tests.
In this engaging podcast episode, we delve into the intricate world of medical device development, shedding light
Revolutionizing Medicine: Combination Drug Delivery Devices and Compliance with ISO 13485, and Design Control Guidelines, with a
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
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.
