ISO 13485:2016
DEVICE DEVELOPMENT
DEVICE DEVELOPMENT
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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
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.
