Nectar’s regulatory expertise, rooted in successful engagements with authorities like the FDA, MHRA, and EMA, is bolstered by our ISO 13485 certification. This global standard affirms our commitment to the highest quality management in medical device development. Our thorough internal compliance audits ensure adherence to rigorous international safety and quality standards.
Regulatory Process for Market Success
Nectar’s regulatory services integrate early assessment into design and development, ensuring efficient submissions and built-in risk management. By staying ahead of shifting standards and documentation requirements, we optimize the design control phases, keeping surprises to a minimum and streamlining the path to market.
Our approach begins with a thorough assessment of user needs, particularly unmet ones, to motivate product innovation. We establish a comparative analysis for intended use and indications, guiding the regulatory classification and setting the level of testing and submission requirements. This critical step forms the foundation of our development planning, ensuring global market readiness.
Nectar strategically determines the need for clinical evaluations based on product classification and regulatory jurisdiction. Our risk assessment protocols prioritize patient safety and resource optimization, providing a solid basis for any required clinical study applications and ensuring alignment with regulatory expectations for performance evidence.
As products evolve, our regulatory team works in tandem with engineers, ensuring design and evaluation reports meet quality and regulatory standards. This phased confirmation may include pre-submission FDA meetings and optimized preclinical testing plans. Finally, our thorough DESIGN TRANSFER review process ensures that any device is market-ready, with future models and modifications envisioned from the outset.
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.