管理专业知识 &
质量认证
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.
战略 产品评估
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.
临床评价 &
风险管理
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.
分阶段发展的
与市场转型
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.
Changing the world one breakthrough medical device at a time.
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