ISO 13485:2016

ISO 13485:2016 Certification and MDSAP: Nectar’s Pledge to Medical Device Quality Excellence

ISO 13485:2016 Certification and MDSAP: Nectar’s Pledge to Medical Device Quality Excellence

What is the significance of ISO 13485:2016 certification for medical device companies like Nectar?

In the world of medical devices, where precision and safety are paramount, adhering to stringent quality standards is non-negotiable. Every device that reaches the hands of healthcare professionals and vulnerable patients must undergo a rigorous process to ensure its reliability and safety. Nectar, a frontrunner in medical device innovation, has consistently prioritized user safety through meticulous safety assessments at every phase of development. This ensures its reliability and safety throughout its lifecycle. Adherence to rigorous quality standards is pivotal in maintaining the trust and credibility of both end-users and stakeholders in the industry.

Nectar’s legacy is deeply entrenched in prioritizing user safety. The company has been steadfast in its commitment, evident through meticulous safety assessments at every development phase. This allegiance to the user is further strengthened by its unwavering compliance with globally recognized regulatory frameworks. These frameworks have been thoughtfully architected to set and maintain the zenith of quality standards in the industry.

The Evolution of ISO 13485

The ISO 13485 standard has its roots in the broader ISO 9001 quality management system standards. However, the ISO 13485 was specifically tailored for the medical device industry, emphasizing risk management, regulatory compliance, and ensuring product safety. Since its inception, the ISO 13485 standard has undergone multiple revisions to align with the dynamic landscape of medical technologies and global regulatory requirements, with the 2016 revision being the most current and comprehensive.

What is ISO 13485:2016 Certification and Why is it Important?

The journey of ensuring medical device safety is shaped by influential organizations such as the International Organization for Standardization (ISO), a global standard-setter for quality and risk management across various sectors, including medical devices. Nectar proudly holds the ISO 13485:2016 certification, a testament to its dedication to maintaining exemplary safety and quality standards.

The ISO 13485:2016 certification, in particular, stands as a beacon for excellence in medical device safety and quality. Wearing this certification as a badge of honor, Nectar demonstrates its unwavering dedication to maintaining unparalleled safety and quality standards. But what does it truly signify?

In essence, ISO 13485:2016 certification underscores the adept implementation of a robust Quality Management System (QMS). A QMS that diligently governs and provides oversight to every nuanced facet of medical device creation. While it’s plausible for many organizations to claim adherence to ISO 13485:2016 standards, earning this prestigious accolade is a rigorous endeavor. It demands comprehensive internal audits, a commitment to continuous improvement, and tangible proof of an organization’s persistent dedication to ensuring the paramount safety, unyielding reliability, and superior quality of their offerings.

The Pillars of ISO 13485:2016

Risk Management: At the heart of ISO 13485:2016 is the principle of risk management. It ensures that medical devices are designed and manufactured considering all potential risks to patients, healthcare providers, and other stakeholders. The process of risk management continues throughout the product lifecycle, from conceptualization to post-market surveillance.

Regulatory Compliance: ISO 13485:2016 aligns with global regulatory requirements, ensuring that certified companies like Nectar are better equipped to navigate the intricate maze of international regulations. This makes it easier for them to launch products in multiple markets.

Continuous Improvement: The standard promotes a culture of continuous improvement. This means companies are not just resting on their laurels but are proactively seeking ways to refine processes, enhance product quality, and respond to feedback.

Benefits Beyond Certification

Global Market Access: With ISO 13485:2016 certification, companies like Nectar gain easier access to global markets. Many countries view this certification as a prerequisite for medical device approvals, thus simplifying the entry process.

Stakeholder Trust: By achieving and maintaining this certification, Nectar builds a reservoir of trust with stakeholders, including distributors, healthcare professionals, and patients.

Operational Excellence: ISO 13485:2016 drives operational efficiency. The rigorous processes and best practices help companies streamline operations, reduce wastage, and optimize resource utilization.

Challenges & How Nectar Overcomes Them

Attaining and maintaining ISO 13485:2016 certification is not without challenges. It demands substantial investment in training, infrastructure, and regular audits. Nectar, with its deep industry knowledge and a team of dedicated professionals, has seamlessly integrated the ISO requirements into its core operations. Continuous training, regular internal audits, and an ethos of embracing global best practices underpin Nectar’s success in this realm.

What does ISO 13485:2016 Certification Entail?

ISO 13485:2016 certification signifies the implementation of a robust Quality Management System (QMS) that meticulously oversees every facet of medical device creation. While many companies may operate according to ISO 13485:2016 standards, obtaining official accreditation involves rigorous internal audits that demonstrate a company’s unwavering commitment to ensuring the safety, reliability, and top-notch quality of their products.

Beyond Patient Safety: How ISO 13485:2016 Benefits Companies

Beyond ensuring patient safety, ISO 13485:2016 certification provides an invaluable layer of credibility for medical device companies like Nectar. Investors and financial institutions often view this certification as a measure of reliability, endorsing a company’s reputation and the safety of their products. This stamp of approval has the potential to bolster success and profitability, making it a sought-after marker for growth-oriented businesses.

This indelible stamp of approval holds immense potential. It can fuel success, spur profitability, and provide a competitive edge, making it an aspirational marker for businesses poised for exponential growth and market leadership.

Nectar’s Enduring Commitment to Excellence

Nectar has always been synonymous with precision, reliability, and dedication to advancing medical device technology. With more than seven years proudly bearing the ISO 13485:2016 certification, Nectar’s journey reflects its enduring commitment to meeting and surpassing international benchmarks of quality.

Deep-rooted in a Culture of Compliance and Safety

Nectar’s adherence to ISO certification is not just about meeting a checklist of criteria. It’s an ingrained part of the company’s ethos. At its core, the ISO 13485:2016 certification emphasizes rigorous quality management systems, continuous improvements, and most importantly, a patient-first approach. Nectar has internalized these values and put them into practice across all facets of its business. This commitment ensures that each medical device, from conception to delivery, undergoes meticulous scrutiny to guarantee optimal performance and user safety.

The Journey of a Nectar Product: Setting Industry Benchmarks

When one examines the lifecycle of any of Nectar’s products, what stands out is the rigorous, systematic approach to design and manufacturing. The company’s ISO certification journey started over seven years ago, but their legacy of commitment to quality and safety predates even this accomplishment. Every phase, from ideation to prototyping, from testing to production, echoes Nectar’s dedication to excellence. Leveraging cutting-edge technology, ongoing employee training, and a robust feedback mechanism, Nectar ensures that its products not only comply with but often surpass global quality standards.

Building Trust and Assurance in a Dynamic Medical Landscape

In an ever-evolving medical device industry, trust is paramount. Healthcare professionals, patients, and stakeholders need to have unwavering confidence in the tools and devices they utilize. Nectar’s longstanding ISO certification serves as a beacon of that trust. Every product bearing the Nectar name assures users of its world-class quality, safety, and reliability. This assurance is further amplified by countless testimonials, industry accolades, and peer reviews, underlining Nectar’s dominant position in the medical device realm.


ISO 13485:2016 certification goes beyond a mere label; it embodies a commitment to excellence, safety, and credibility within the medical device industry. Nectar’s steadfast adherence to these standards not only ensures patient well-being but also positions the company as a reliable and secure partner for investors and clients alike. As a beacon of innovation, Nectar’s ISO 13485:2016 certified QMS stands as a testament to its dedication to creating safe, reliable, and high-quality medical devices that transform lives.

Intrigued to know more? For deeper insights into how the rigor of Nectar’s ISO 13485:2016 certified QMS can exponentially elevate your product development trajectory, we invite you to reach out. At Nectar, your aspirations, safety, and success form the bedrock of our ethos. Let’s shape the future of medical devices, together. Your journey to excellence begins here, with Nectar.

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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.
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What is ISO 13485:2016 certification, and why is it crucial for companies like Nectar?

ISO 13485:2016 is a certification ensuring quality management for medical device development. It’s vital for Nectar to show commitment to safety and quality.

How does ISO 13485:2016 certification benefit companies beyond safety?

Besides safety, ISO 13485:2016 enhances credibility, attracting investors and partners for growth and success.

How does Nectar stand out with its ISO 13485:2016 certification?

Nectar’s ISO certification reflects dedication to top-tier safety and quality, backed by over three years of proven excellence in design and manufacturing.

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

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Mechanical engineering, Industrial Design, Software
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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

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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.

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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.
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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.
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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.
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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.
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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.

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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.
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Rejsa Kuci

Business Development Coordinator

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Belen Quintero

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Kerry Eiss

Clinical Expert - RN, BSN, CLNC

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Flaka Brahimi

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Stephanie Rodriguez

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Sean Wells

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Jonathan Cantera

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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.
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Uran Çabra

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