ISO 13485:2016

Navigating EMI Challenges with IEC 60601-1-2 Compliance

Navigating EMI Challenges with IEC 60601-1-2 Compliance

In today’s fast-paced technological landscape, electronic devices have seamlessly integrated into our daily lives. However, amidst this rapid advancement, there exists an often-overlooked challenge: Electromagnetic Interference (EMI). EMI occurs when electronic devices are exposed to electromagnetic fields, potentially disrupting their functionality and posing safety hazards. In this comprehensive article, we will delve into the multifaceted realm of EMI, its profound implications for critical applications, and strategies for effective mitigation, with a special focus on IEC 60601-1-2 compliance.

Understanding Electromagnetic Interference (EMI)

Electromagnetic Interference, or EMI, is the disruptive interference caused when electronic devices are exposed to electromagnetic fields. Virtually any device with electronic circuitry can fall prey to EMI, and with the proliferation of increasingly complex electronic devices, EMI has emerged as a pressing concern.

To comprehend the depth of this challenge, consider an example from the medical field. A hospital’s monitoring equipment, including vital signs monitors and MRI machines, relies heavily on electronic components. If these devices experience EMI, it can lead to erroneous readings or malfunctions, endangering patient health. Hence, understanding and mitigating EMI is crucial in such critical applications.

EMI Testing and Certification

One vital aspect of EMI mitigation, especially in critical applications, is rigorous testing and certification. Organizations must ensure that their devices comply with industry-specific standards and regulations. EMI testing involves subjecting electronic devices to various electromagnetic conditions to assess their susceptibility and emissions. This process helps identify potential issues and allows for necessary adjustments during the development phase. Additionally, obtaining certifications, such as FCC compliance for wireless devices or IEC 60601-1-2 compliance for medical devices, is essential to gain market clearance and maintain credibility. Nectar’s experienced engineers are well-versed in the intricacies of EMI testing and certification, ensuring that your products meet the required standards.

Evolving EMI Challenges in the IoT Era

As we enter the era of the Internet of Things (IoT), the landscape of EMI is evolving. With a multitude of interconnected devices communicating wirelessly, the potential for EMI-related disruptions is on the rise. For example, in a smart home environment, interference from one IoT device can impact the performance of others, affecting the overall user experience. This necessitates a proactive approach to EMI mitigation in IoT product development. Engineers must not only consider individual device susceptibility but also the complex interactions within IoT ecosystems. Addressing these challenges requires innovative solutions and expertise in wireless communication and IoT device design.

Nectar’s Holistic Approach to EMI Mitigation

Nectar takes a holistic approach to EMI mitigation, recognizing that it extends beyond mere compliance. Our comprehensive services encompass the entire product development lifecycle, from concept to market launch. We collaborate closely with our clients to understand their specific needs and tailor EMI mitigation strategies accordingly. Whether you’re developing medical devices, industrial automation systems, or cutting-edge IoT solutions, our seasoned team of engineers brings a wealth of experience to the table. We emphasize the importance of early-stage EMI considerations, iterative testing, and continuous improvement to ensure that your devices not only meet regulatory requirements but also exceed performance expectations. By partnering with Nectar, you gain a trusted ally in navigating the complexities of EMI mitigation in today’s dynamic technological landscape.

EMI in Critical Applications: A Vital Consideration

Within critical applications in the medical, scientific, and industrial sectors, understanding EMI is paramount. Engineers must grasp how electromagnetic energy in the product environment can induce interference, resulting in temporary disruptions, data loss, and, in advanced systems, even jeopardizing lives.

Let’s explore a scenario in the industrial sector. An automated manufacturing plant employs various robotic systems for precision tasks. EMI can interfere with the control systems of these robots, leading to costly production errors, downtime, and maintenance expenses. Thus, mitigating EMI becomes an essential aspect of maintaining operational efficiency and minimizing financial losses.

Sources and Manifestations of EMI

EMI can manifest in various forms, stemming from both human-made and natural sources. Man-made EMI often arises from continuous signal sources, while natural EMI can originate from cosmic phenomena like lightning and other atmospheric disturbances. When designing intricate devices with interconnected subsystems, addressing electrostatic discharge is virtually inevitable.

Consider an example in the scientific field. A laboratory conducting sensitive experiments relies on electronic instruments to collect and analyze data accurately. Even a minor EMI event, such as a nearby lightning strike, can corrupt the data and render months of research invalid. This highlights the need for robust EMI mitigation strategies in research environments.

EMI Susceptibility in Medical Devices: A Growing Challenge

The ever-evolving landscape of technology, particularly in medical devices, has escalated EMI susceptibility, raising concerns about patient safety. EMI can render devices nonfunctional, posing fire hazards in oxygen-enriched environments during patient treatment. To safeguard clinical environments from EMI-induced disturbances, electrical engineering teams must take proactive measures to prevent, detect, and rectify EMI issues.

Let’s delve deeper into the medical field. Imagine a scenario in which a life-supporting medical device, such as a ventilator, experiences EMI due to electromagnetic interference from nearby electronic equipment. In such a critical situation, the patient’s life is at risk. Proactive EMI mitigation measures, including shielding, filtering, and compliance with standards like IEC 60601-1-2, are essential to prevent such life-threatening events.

Proactive EMI Mitigation: An Essential Design Approach

In the realm of electronic design, proactive EMI mitigation is imperative from the outset. This strategic approach acts as a protective shield against disruptions caused by electromagnetic fields, ensuring device functionality and integrity. By adopting preemptive measures, engineers can not only avert EMI-related challenges but also identify and resolve interference-induced disturbances before they escalate. This proactive stance guarantees seamless device operation, upholding reliability and performance while minimizing costly revisions and delays.

Let’s examine the implications of proactive EMI mitigation in the industrial sector. A company specializing in automated control systems for manufacturing plants decides to integrate EMI shielding and filtering components into its designs from the initial stages. As a result, the control systems are less susceptible to EMI, leading to increased production efficiency and reduced maintenance costs.

Challenges in PCB/PCBA Development due to EMI

Effective EMI mitigation necessitates experienced engineers and a development team equipped with the requisite quality management system. Compliant devices are integral to medical device design, impacting product cost and market clearance timing. Nectar boasts seasoned engineers with extensive expertise in electronic hardware, sensors, PCB design and assembly, firmware integration, and software engineering. This breadth of skills enables us to provide companies with an external resource dedicated to addressing board development challenges.

Consider a scenario in which a startup specializing in wireless communication devices faces challenges in obtaining FCC certification due to EMI issues. Partnering with Nectar, a team of experts in EMI mitigation and compliance, helps the startup identify and rectify EMI-related shortcomings, expediting their product’s market entry.

Emerging Technologies and EMI Challenges

As technology continues to advance, new and emerging technologies bring unique EMI challenges. For example, the adoption of 5G networks and the development of autonomous vehicles introduce novel sources of electromagnetic interference. These technologies demand specialized EMI mitigation solutions to ensure their safe and reliable operation. Engineers and researchers are constantly exploring innovative approaches to address these challenges, emphasizing the importance of staying at the forefront of EMI mitigation research and development. Nectar’s commitment to staying abreast of emerging technologies positions us as a trusted partner for organizations navigating the ever-evolving landscape of EMI challenges. By embracing cutting-edge solutions, we help our clients achieve not only compliance but also a competitive edge in their respective industries.

With this additional paragraph, the article continues to provide valuable insights into the evolving landscape of EMI challenges, particularly in the context of emerging technologies such as 5G networks and autonomous vehicles.

Leveraging Expertise: Partnering with Nectar for IEC 60601-1-2 Compliance

In today’s evolving landscape, resource allocation, scaling, and budgetary considerations are paramount. Rather than burdening your internal team, consider partnering with a design house like Nectar to mitigate the risks associated with successful EMI/EMC testing, especially in the context of IEC 60601-1-2 compliance.

For a medical device manufacturer striving to meet IEC 60601-1-2 standards, collaborating with Nectar offers a streamlined approach. Our team’s extensive experience in compliance and thorough understanding of EMI-related challenges ensures that your devices not only meet regulatory requirements but also maintain the highest levels of patient safety and operational reliability.

In Summary

In the dynamic world of modern electronics, understanding and mitigating Electromagnetic Interference is critical for ensuring device reliability, patient safety, and overall project success. By collaborating with seasoned experts, companies can navigate the intricate EMI landscape, develop compliant devices, and bring their innovations to market while minimizing risks and delays, all while adhering to standards such as IEC 60601-1-2.

With a focus on proactive EMI mitigation, compliance, and the unique challenges faced in critical applications, organizations can ensure the seamless integration of electronic devices into our ever-advancing technological landscape.

Post New Nectar logo building
Nectar is an award-winning design & engineering consultancy with a specialization in medical device development. We are proudly 13485 certified, we adhere to the highest industry standards. Nectar has been an industry leader in Southern California for over 25 years. Our proven user-centered design process has facilitated the successful launch of hundreds of products in the market.
Nectar logo color

The news you need to stay on top of cutting edge medical product development.

By subscribing, you acknowledge and agree to Nectar’s Terms of Use and Privacy Policy.


What is Electromagnetic Interference (EMI), and why does it matter for electronic devices?

Electromagnetic Interference (EMI) disrupts electronic devices in the presence of electromagnetic fields, causing malfunctions and safety risks. EMI’s relevance has grown with complex electronics, affecting critical sectors like medicine and industry.

How does EMI affect medical devices, and what are the risks?

EMI can disable medical devices, endangering patients in oxygen-rich environments. Susceptibility to EMI in medical equipment can compromise patient care and device safety.

How can engineering teams handle EMI during development?

Engineering teams prevent, detect, and fix EMI-related issues proactively. They identify EMI sources, use shielding methods, and collaborate with experts like Nectar for successful EMI testing, compliance, and reliable device functionality.

Nectar logo color

We are an ISO 13485-certified design and engineering firm based in Southern California, specializing in the development of cutting-edge medical devices.

Our Services
Mechanical engineering, Industrial Design, Software
Firmware, Usability, User interface design, Regulatory

Acumen IQ device in use

Related Blogs

Why Systems Engineering is Critical In the Design & Manufacturing of Medical Devices

There is one crucial team member in the development process who can help ensure ultimate project success: the Systems Engineer.

Read Now

AI Unleashed: Revolutionizing Convenient In-Vitro Diagnostics

In the laboratory setting, the advent of AI has been nothing short of revolutionary. Instruments equipped with...

Read Now

Redefining Healthcare With IoT

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).

Read Now
image 65

Darren Saravis


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

image 65 (1)

Steven Wells Ph.D.

Director of Operations

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.

image 65 (2)

Nellie Roque

Director of Finance and Accounting

Nellie Roque is a seasoned professional with over 17 years of experience in the fields of accounting, human resources, and payroll. She has a wide range of experience, having worked in industries such as manufacturing, software, and non-profit organizations. Nellie holds a Bachelor’s degree in Business Administration and Accounting, demonstrating her strong foundation in financial management and human resource practices. Throughout her career, Nellie has gained extensive knowledge and expertise in these areas, making her a valuable asset to any organization.
image 65 (3)

John Duval

Principal Engineer

John is a true asset to Nectar, having been a founding member and instrumental in shaping the company’s portfolio and establishing its reputation for engineering excellence. With over 30 patents and numerous design awards to his name, John is a master of product architecture and subsystem integration, as well as design for manufacture, mechanisms, and root cause analysis. His passion for creating simple and holistic solutions that take into account a wide range of variables is evident in his work and has made him a valuable member of the Nectar team.
image 65 (4)

Aaron Gifford

Principal Engineer

With a wealth of experience as a medical device developer, Aaron is a valuable addition to the Nectar team. His expertise in transferring medical devices and IVD instruments to production is unmatched, and his 25 years of professional engineering experience speaks to his expertise. At Nectar, Aaron plays a crucial role in ensuring regulatory compliance throughout product development and manages projects with skill and precision. His recent leadership in the development of the critical care Covid EUA BDR-19™ ventilator is a testament to his abilities, and his 13 patents in the medical device space further highlight his contributions to the field.
image 65 (5)

Larry Larson

Director of Hardware and Firmware Engineering 

Larry Larson is a highly experienced engineering professional who has served as Nectar’s Director of Engineering for several years. He has extensive experience in leading, overseeing, and managing the design and development of innovative products, and has been involved in 70 unique product design cycles to date. With a deep understanding of highly regulated industries such as medical and aerospace devices, Larry has been instrumental in bringing cutting-edge technologies to market and delivering solutions that meet the needs of his clients. He has a passion for engineering and is dedicated to advancing the field by delivering products that are safe, effective, and of the highest quality.
image 65 (6)

Adam Marten

Senior Mechanical Engineer

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.

image 65 (7)

James Wilkin

Industrial Design Manager

James is a seasoned professional with over seven years of experience at Nectar, where he brings his expertise in industrial design, user interface, and user experience to the table. With a background in the highly competitive automotive industry, working for heavyweights like Daimler and Tesla, James is a true asset to the Nectar team. He is responsible for ensuring that the company adheres to user-centered design best practices, and he works closely with clients and partners on crucial human factors strategies for FDA submissions and the overall usability engineering process. James’ achievements in this field speak to his exceptional skills and dedication to the work he does.
image 65 (8)

Rejsa Kuci

Business Development Coordinator

Rejsa is a dynamic force in driving sales and acquiring new projects at Nectar, where she excels in seamlessly aligning the Sales and Operations teams. Holding a prestigious double degree from the Rochester Institute of Technology in Management and Multimedia, Rejsa brings a wealth of experience to her role as a Project Manager, Digital Marketing Strategist, and Creative Lead. With over four years of expertise in the digital world, Rejsa is not only highly skilled but also enthusiastic about following the ISO 13485 path to ensure successful project completion. Her ability to effectively bridge the gap between Sales and Operations, combined with her passion for driving projects forward, makes her an invaluable asset to the Nectar team.
image 65 (9)

Belen Quintero

Associate Project Manager

Belen is a project manager at Nectar who brings a wealth of experience and expertise to her role. With a strong background in Mathematics and Philosophy from the University of California, Riverside, she has honed her skills in a variety of industries including healthcare ,education, food manufacturing, and engineering. Belen’ success as a project manager is due in large part to her ability to align projects with business goals, clearly define project needs, lead cross-functional teams, and effectively communicate results to stakeholders. With her proven track record of success, Belen is a valuable asset to the Nectar team and a key player in driving the company’s projects forward.
image 65 (10)

Erjon Ameti

Mechatronics Engineer

Erjon Ameti is a highly knowledgeable Mechatronics Engineer with a wealth of experience in both academic settings and startup environments. With a strong background in electronics, robotics, and 3D modeling, he possesses a unique combination of skills that allow him to excel in the fields of automation systems and mechatronics. Over the past five years, Erjon has honed his expertise in product development and industrial automation, emerging as a leading authority in his field. Currently, Erjon works at Nectar as a hardware engineer, where he is responsible for documentation, CAD design, and electronics in general. He has been involved in the entire process of Nectar engineering, bringing his expertise and experience to the forefront of the company’s success.
image 65 (11)

Redon Berisha

Electronics Engineer

Redon is a highly skilled engineer with a passion for technology and innovation. He has a background in mechatronics, which has given him a strong foundation in electronics, including electronic design, PCB design, and cable design. Redon excels in the critical components of the design process, including documentation for assemblies, testing, debugging, and ensuring each project is completed to the highest standard. At Nectar, he plays a crucial role in the creation of cutting-edge technology, bringing his unique vision to life and making him a valuable member of the team. With his technical expertise and creative vision, Redon is a leader in the field of electronic design.
image 65 (12)

Kerry Eiss

Clinical Expert - RN, BSN, CLNC

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.

image 65 (13)

Flaka Brahimi

Marketing Manager

Flaka, a highly skilled professional with a background in Architecture and Spatial Planning from the University of Business and Technology in Pristina, holds a dual role at Nectar as both the Marketing Project Manager and a valuable member of the Business Development team. In her role as Marketing Project Manager, she is responsible for overseeing the development and execution of marketing strategies and as a member of the Business Development team, she actively contributes to the growth of the company by assisting in the creation of impactful marketing tactics. With her diverse background and expertise, Flaka plays a crucial role in ensuring the success of Nectar’s projects.
image 65 (14)

Brayton Hammerli

User Experience Designer

Brayton is a multi-disciplinary designer with a A.A in Studio Arts and a B.S in Industrial Design from California State University Long Beach. As a user experience designer, Brayton specializes in usability evaluations, user research, feedback studies, GUI design, mobile app design, human factors evaluations, and formative studies. In his free time, Brayton enjoys outdoor activities such as hiking, mountain biking as well as other creative pursuits. He approaches problems with a solution-focused mindset and enjoys exploring ideas. 
image 65 (15)

Stephanie Rodriguez

Accounting Coordinator

Stephanie Rodriguez is a highly experienced administrative professional with over 10 years of expertise across a diverse range of industries, including contract manufacturing, financial and wealth management, and the medical field. She holds a Bachelor’s degree in Humanities from Northern Arizona University. As a valued member of the Nectar team, Stephanie plays an integral role in supporting the engineering teams by acquiring materials and parts for the prototype phase of our clients’ projects. She also assists the Director of Accounting by issuing purchase orders and provides project managers with accurate data to effectively manage and track budgets for each stage of the statement of work. Stephanie’s knowledge and skills, combined with her dedication and drive, make her an asset to Nectar and a key player in ensuring the successful completion of our projects.
image 65 (16)

Toska Ukaj

Scientific Content Writer

Toska Ukaj is a gifted writer who brings a wealth of expertise and passion to Nectar. With a background in medical science and years of experience producing high-quality scientific and medical publications, Toska’s writing skills are unparalleled. She boasts an excellent educational record, advanced interpersonal skills, and a deep passion for healthcare. As Nectar’s writer, Toska consistently produces clear, concise pieces that can be easily understood by the public and truly captures the essence of Nectar’s mission. With her exceptional writing abilities and commitment to healthcare, Toska is an invaluable asset to the Nectar team.
image 66

Sean Wells

Mechanical R&D Technician

Sean plays a critical role at Nectar. He has a wide range of skills that help keep the company and equipment running. His background in machine and building maintenance means he has skilled hands ready for anything. Sean runs our lab equipment including 3D printers and a laser cutter. He also helps with complex project builds, assemblies, and testing.
image 65 (18)

Jonathan Cantera

Quality Manager

Jonathan at his core is a Human Factors Engineer with his M.S. in Human Factors and Minor in Sociology from California State University of Long Beach. At Nectar, Jonathan is responsible for managing and maintaining the company’s ISO 13485 Quality Management System keeping in compliance with US and international regulations for product development. Jonathan’s role ensures each department is in compliance every step of the design process, making him a critical Nectar team member. Jonathan’s Human Factors background also allows him to aid in user research, feedback sessions, usability evaluations, and formative studies such as risks assessments. When he’s not in the office, Jonathan enjoys film photography, and reading.
Vessa Hyseni Purchasing Manager

Vesa Hyseni

Purchasing Manager

Vesa is a skilled Purchasing Manager with a strong focus on procurement strategies and vendor management. With a track record of successfully leading procurement teams, Vesa excels in optimizing procurement processes, consistently striking a balance between quality assurance and cost-effectiveness. Her ability to identify cost-saving opportunities and manage supplier relationships effectively makes her an indispensable asset to Nectar.
Uran Cabra Engineer

Uran Çabra

Software Engineer

Uran Çabra, with a background in Mechatronic Systems Engineering, has been working on Embedded Systems, specifically on IoT product development. His responsibilities include firmware development and electronics design and testing. He holds a master’s degree in Electrical Engineering with a focus on Autonomous Mobile Robotics.
Sarah Clark UX UI Designer

Sarah Clark

Industrial Designer

Sarah has a background in fine art & graphic design with a B.S in Industrial Design from California State University Long Beach. As a user experience designer her specialties include: keen aesthetics, creative problem solving, a detail oriented approach to research, and improving user journeys within complex experiences.