甘露的监管专业知识, rooted in successful engagements with authorities like the FDA, MHRA, 和教育津贴, 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.
规管程序 市场的成功
甘露的监管cq9电子游戏平台网址将早期评估整合到设计和开发中, 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, 特别是未满足的, 激发产品创新. We establish a comparative analysis for intended use and indications, 指导法规分类,制定检测和提交要求的等级. This critical step forms the foundation of our development planning, 确保全球市场准备就绪.
Nectar strategically determines the need for clinical evaluations based on product classification and regulatory jurisdiction. 我们的风险评估方案优先考虑患者安全和资源优化, providing a solid basis for any required clinical study applications and ensuring alignment with regulatory expectations for performance evidence.
随着产品的发展, our regulatory team works in tandem with engineers, 确保设计和评估报告符合质量和法规标准. 这一阶段的确认可能包括提交前的FDA会议和优化的临床前测试计划. 最后, 我们彻底的DESIGN TRANSFER审查过程确保任何设备都可以上市, with future models and modifications envisioned from the outset.
达伦是一位多才多艺、充满活力的领导者,他创立了Nectar、X-Naut和BreathDirect. 他致力于通过技术、科学和艺术的综合来改善世界. 在达伦的领导下, Nectar is leveraging the latest advances in cutting-edge technology to transform medical device development and design. 作为他的
Dr. Steve Wells在指导Nectar的运营和确定其战略方向方面发挥着关键作用. 他卓有成效的领导为公司的成功开辟了一条清晰的道路. He has revitalized the company with a passion for maximizing impact through expert resource utilization since taking the helm in 2020. 史蒂夫提升了甘露的pg电子游戏哪个平台好, 简化流程, and reinvigorated its innovation agenda, all with the goal of developing life-saving and impactful products. 他在乔治菲舍尔担任高级领导职务的背景和他以人为本的思想, 以结果为导向的领导风格使他成为我们pg电子游戏哪个平台好的宝贵财富. Steve’s extensive knowledge in chemistry, 生物相容性, and biology only adds to his value as a team member.
亚当貂 has worked in the aerospace and consumer products industries since 2006 with lead engineering experience in conceptual design, 产品开发, analysis and performance qualification 测试. Adam has experience leading a range of technical projects, 包括军事和航空航天应用的多种结构分析. He has also worked directly with engineering teams to develop medical devices and laboratory instrumentation.
With over two decades of experience in healthcare innovation, 凯瑞在改变全球患者护理和改善患者预后方面发挥了重要作用. 她在心血管和心胸外科手术室的丰富知识和专业知识, as well as her experience in emergency medicine, 老年病学, 儿童精神病学, 主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, 包括EPIC的使用, 欧洲核子研究中心, and Meditech electronic charting systems, have positioned her as a leader in her field. Her recent involvement in helping transition the Providence St. Vincent 医疗 Center’s Cardiac Surgery program from paper charting to electronic documentation further underscores her commitment to advancing the healthcare industry.