ISO 13485:2016


ISO 13485:2016认证


ISO 13485认证:它是什么?

Safety and quality are essential to the medical device industry, 这就是为什么建立ISO 13485认证的质量管理体系是确保这些设备正确开发的关键. 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 产品开发.

您如何获得ISO 13485认证?

While many 产品开发 companies operate to ISO 13485 certification standards for medical devices and 软件, 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, 确保从仪器校准到文件命名的一切工作, 是密封的. Successful completion of audits show that a company’s practices are completely oriented to ensure their designs meet FDA standards of documentation.


甘露开发的产品必须值得信赖,以改善,有时甚至挽救,病人的生命. 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.

对于Nectar来说,获得ISO 13485认证不仅仅是持有这个高质量的证书. 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. 从研究到验证, Nectar’s quality engineers track and record every single variable to ensure our medical devices and products are safe and reliable.

为我们的pg电子游戏哪个平台好和消费者, our ISO 13485 medical device certification and quality assurance system can assure that your medical devices and 软件 systems are achieving the most prestigious standards possible in the global market.




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

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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, results-driven leadership style make him an invaluable asset to our team. Steve’s extensive knowledge in chemistry, 生物相容性, and biology only adds to his value as a team member.

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内莉罗克是一位经验丰富的专业人士,在会计领域拥有超过17年的经验, 人力资源, 和工资. 她有广泛的经验, having worked in industries such as manufacturing, 软件, 非营利组织. Nellie holds a Bachelor’s degree in Business Administration and Accounting, 显示她在财务管理和人力资源实践方面的坚实基础. 在她的职业生涯中, Nellie has gained extensive knowledge and expertise in these areas, making her a valuable asset to any organization.
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约翰是甘露的宝贵财富, 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, 以及为制造而设计, 机制, 根本原因分析. 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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With a wealth of experience as a medical device developer, Aaron is a valuable addition to the Nectar team. 他在将医疗设备和IVD仪器转移到生产方面的专业知识是无与伦比的, 他25年的专业工程经验证明了他的专业知识. 在花蜜, Aaron plays a crucial role in ensuring regulatory compliance throughout 产品开发 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, 他在医疗器械领域的13项专利进一步凸显了他对该领域的贡献.
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Director of Hardware and 固件 Engineering 

拉里•拉森 is a highly experienced engineering professional who has served as Nectar’s Director of Engineering for several years. 他有丰富的领导经验, 监督, and managing the design and development of innovative products, and has been involved in 70 unique product design cycles to date. 对医疗和航空航天设备等高度监管的行业有深入的了解, Larry has been instrumental in bringing cutting-edge technologies to market and delivering solutions that meet the needs of his clients. 他对工程充满热情,并致力于通过提供安全的产品来推动该领域的发展, 有效的, 而且质量最好.
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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. 他还直接与工程pg电子游戏哪个平台好合作开发医疗设备和实验室仪器.

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James是一位经验丰富的专业人士,在Nectar工作超过7年, where he brings his expertise in industrial design, 用户界面, 以及用户体验. 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. 他负责确保公司坚持以用户为中心的设计最佳实践, and he works closely with clients and partners on crucial human factors strategies for FDA submissions and the overall usability engineering process. 詹姆斯在这个领域的成就说明了他卓越的技能和对工作的奉献精神.
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Rejsa Kuci


Rejsa是Nectar推动销售和获得新cq9电子游戏平台网址的动力, where she excels in seamlessly aligning the Sales and Operations teams. 拥有罗彻斯特理工学院管理和多媒体专业的双学位, Rejsa brings a wealth of experience to her role as a Project Manager, 数字营销战略家, 创意领导. With over four years of expertise in the digital world, Rejsa is not only highly skilled but also enthusiastic about following the ISO 13485 path to ensure successful project completion. Her ability to 有效的ly bridge the gap between Sales and Operations, combined with her passion for driving projects forward, makes her an invaluable asset to the Nectar team.
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Belen Quintero


Belen是Nectar的一名cq9电子游戏平台网址经理,她为她的角色带来了丰富的经验和专业知识. 拥有加州大学数学和哲学的深厚背景, 河畔, she has honed her skills in a variety of industries including healthcare ,教育, 食品生产, 和工程. Belen作为cq9电子游戏平台网址经理的成功在很大程度上归功于她将cq9电子游戏平台网址与业务目标结合起来的能力, 清楚界定cq9电子游戏平台网址需要, 领导跨职能pg电子游戏哪个平台好, and 有效的ly communicate results to stakeholders. With her proven track record of success, Belen是Nectarpg电子游戏哪个平台好的宝贵财富,也是推动公司cq9电子游戏平台网址向前发展的关键人物.
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Erjon Ameti


Erjon Ameti is a highly knowledgeable 机电一体化工程师 with a wealth of experience in both academic settings and startup environments. With a strong background in electronics, 机器人, 和3D建模, he possesses a unique combination of skills that allow him to excel in the fields of automation systems and mechatronics. 在过去的五年里, Erjon在产品开发和工业自动化方面拥有丰富的专业知识, emerging as a leading authority in his field. 目前, Erjon works at Nectar as a hardware engineer, where he is responsible for documentation, 计算机辅助设计, 以及一般的电子产品. He has been involved in the entire process of Nectar engineering, 将他的专业知识和经验带到公司成功的最前沿.
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Redon是一位对技术和创新充满热情的高技能工程师. 他有机电一体化的背景, which has given him a strong foundation in electronics, 包括电子设计, PCB设计, 电缆设计. Redon excels in the critical components of the design process, 包括程序集的文档, 测试, 调试, and ensuring each project is completed to the highest standard. 在花蜜, he plays a crucial role in the creation of cutting-edge technology, 将他独特的愿景变为现实,使他成为pg电子游戏哪个平台好中有价值的一员. With his technical expertise and creative vision, Redon is a leader in the field of electronic design.
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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.

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Flaka, a highly skilled professional with a background in Architecture and Spatial Planning from the University of Business and Technology in Pristina, holds a dual role at Nectar as both the Marketing Project Manager and a valuable member of the Business Development team. In her role as Marketing Project Manager, she is responsible for 监督 the development and execution of marketing strategies and as a member of the Business Development team, 她通过协助制定有影响力的营销策略,积极为公司的发展做出贡献. With her diverse background and expertise, Flaka plays a crucial role in ensuring the success of Nectar’s projects.
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Brayton is a multi-disciplinary designer with a A.工作室艺术A和B.S in 工业设计 from California State University Long Beach. 作为一个用户体验设计师, Brayton specializes in 可用性评估, 用户研究, 反馈的研究, GUI设计, 移动应用设计, 人为因素评价, 以及形成性研究. 在他空闲的时候, Brayton enjoys outdoor activities such as hiking, mountain biking as well as other creative pursuits. 他以解决方案为中心的思维方式处理问题,喜欢探索想法. 
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斯蒂芬妮·罗德里格斯 is a highly experienced administrative professional with over 10 years of expertise across a diverse range of industries, 包括合同制造, 财务及财富管理, 以及医疗领域. 她拥有北亚利桑那大学人文学科学士学位. 作为甘露pg电子游戏哪个平台好的重要成员, Stephanie plays an integral role in supporting the engineering teams by acquiring materials and parts for the prototype phase of our clients’ projects. She also assists the Director of Accounting by issuing purchase orders and provides project managers with accurate data to 有效的ly manage and track budgets for each stage of the statement of work. 斯蒂芬妮的知识和技能, 加上她的奉献精神和干劲, 让她成为甘露的一笔财富,并成为确保我们cq9电子游戏平台网址成功完成的关键人物.
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Toska Ukaj


Toska Ukaj是一位才华横溢的作家,她为Nectar带来了丰富的专业知识和激情. With a background in medical science and years of experience producing high-quality scientific and medical publications, Toska’s writing skills are unparalleled. She boasts an excellent 教育al record, 高级人际交往能力, 以及对医疗保健的热情. 作为甘露的作者, Toska始终如一地生产clear, 简洁的作品可以很容易地被公众理解,并真正抓住了甘露使命的精髓. With her exceptional writing abilities and commitment to healthcare, Toska is an invaluable asset to the Nectar team.



肖恩在甘露公司扮演着关键角色. 他拥有广泛的技能,有助于保持公司和设备的运行. 他在机器和建筑维修方面的背景意味着他有一双熟练的手,可以应付任何事情. Sean runs our lab equipment including 3D printers and a laser cutter. He also helps with complex project builds, assemblies, and 测试.
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Jonathan at his core is a Human Factors Engineer with his M.S. 加州州立大学长滩分校人因学辅修社会学. 在花蜜, Jonathan is responsible for managing and maintaining the company’s ISO 13485 Quality Management System keeping in compliance with US and international regulations for 产品开发. 乔纳森的职责是确保每个部门都遵守设计过程的每一步, making him a critical Nectar team member. Jonathan的“人为因素”背景也使他能够帮助用户研究, 反馈会议, 可用性评估, 以及形成性研究 such as risks assessments. When he’s not in the office, Jonathan enjoys film photography, and reading.
Vessa Hyseni采购经理



Vesa是一名熟练的采购经理,专注于采购策略和供应商管理. With a track record of successfully leading procurement teams, Vesa excels in optimizing procurement processes, 始终在质量保证和成本效益之间取得平衡. Her ability to identify cost-saving opportunities and manage supplier relationships 有效的ly makes her an indispensable asset to Nectar.
Uran Cabra工程师



巨蜥Cabra, with a background in Mechatronic 系统工程, 一直致力于嵌入式系统, specifically on IoT 产品开发. 他的职责包括固件开发和电子设计与测试. 他拥有电气工程硕士学位,专注于自主移动机器人.
莎拉克拉克 UX UI设计师



萨拉有美术方面的背景 & 平面设计与B.S in 工业设计 from California State University Long Beach. 作为一个用户体验设计师 her specialties include: keen aesthetics, 创造性地解决问题, a detail oriented approach to research, and improving user journeys within complex experiences.