ISO 13485 | AS9100
DUAL-CERTIFIED QUALITY SYSTEM
DUAL-CERTIFIED QUALITY SYSTEM
ISO 13485 certification: What is it?
Safety and quality are essential to the medical device industry, which is why establishing an ISO 13485 certified QMS is key to ensure these devices are developed correctly. ISO is the International Standardization Organization which defines the requirements for quality management systems specific to various critical industries. The ISO 13485 medical device certification regulations have become the standard of Quality System regulation for the FDA and its international equivalents, focusing on a risk-based approach to product development.
While many product development companies operate to ISO 13485 certification standards for medical devices and software, not all possess their own ISO 13485 Certified QMS. Obtaining ISO 13485 medical device certification for the Quality Management System requires rigorous internal audits by an independent third party. Their inquiry examines a company’s entire body of operating procedures, ensuring everything from the calibration of instruments to the naming of documents, is airtight. Successful completion of audits show that a company’s practices are completely oriented to ensure their designs meet FDA standards of documentation.
Quality Assurance in Nectar’s Process
The products Nectar develops must be trusted to improve, and sometimes even save, patient’s lives. Thus the creation of products must be finely tuned, requiring tedious and detailed assessment; an ISO 13485 certified QMS is proven to support this undertaking.
For Nectar, being ISO 13485 certified goes beyond holding this highly qualified certificate. Our medical device quality assurance has been woven into our DNA as regulatory compliance standards can be found through each step of our proven process. From research to verification, Nectar’s quality engineers track and record every single variable to ensure our medical devices and products are safe and reliable.
For our clients and consumers, our ISO 13485 medical device certification and quality assurance system can assure that your medical devices and software systems are achieving the most prestigious standards possible in the global market.
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
Stefanie brings over 10 years of experience in regulatory affairs and quality assurance, guiding a wide range of medical devices and pharmaceutical products through complex global requirements. She has successfully managed FDA 483 responses, 510(k) submissions, and audits across U.S., EU, APAC, and LATAM markets. Known for her collaborative and solutions-driven approach, Stefanie helps both startups and established companies navigate evolving regulatory landscapes with creative, compliant strategies.
Bryan Chan is a Senior AI and Software Architect with extensive experience in developing AI-driven medical technologies that are both innovative and compliant with industry standards (ISO 62304). His accomplishments include leading the development of: an AI-powered, contactless remote patient monitoring device with LLM-based voice engagement, a closed-loop insulin pump for Type 2 diabetes using on-body sensors, a motorized smart walker with real-time gait analysis, and an FDA-compliant AI SaMD platform for gastrointestinal disease detection. Bryan excels at defining technical vision, building high-performance teams, and navigating complex regulatory pathways to deliver scalable, market-ready MedTech solutions.
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.
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.
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.
Jonathan is a Human Factors Engineer with a background in psychology and sociology, bringing a unique perspective that bridges human behavior, usability, and inclusive design. Grounded in universal design principles, his work focuses on creating safe, accessible, and intuitive user experiences informed by both qualitative and quantitative research. At Nectar, Jonathan leads the Human Factors team, guiding research and risk management efforts through user testing, field studies, and evidence-based evaluations to ensure that every product decision reflects the real needs of its users.
Jenny is a Human Factors Engineer with a strong foundation in psychology, bringing a research-driven approach to usability, workflow analysis, and user-centered design. She has worked across clinical, consumer, and emerging technology spaces, leading studies that examine cognitive workload, fatigue, task performance, and product interaction to optimize safety and usability. At Nectar, Jenny collaborates with cross-functional teams to translate user needs into actionable design recommendations, supporting risk management, formative evaluations, and usability strategies for regulatory submissions.