Regulatory & Consulting

您需要提前思考并询问正确的问题，以发现可能让您退回的潜在监管风险。

Are my preclinical studies addressing biocompatibility endpoints?

Do my predicates align with reimbursement and regulatory goals?

What are the regulatory compliance requirements of my targeted global marketplace?

Efficiently integrating your market approach from conception to completion ultimately saves you time, money and effort. By looking at product classification, required quality standards and required testing upfront, you can avoid unnecessary testing and facilitate discussions with regulators and notified bodies to prepare for regulatory submissions.

我们的监管专家早期开始，检查监管遵守情况的各个方面，以确定可能影响您的设计，材料，制造方法或财务计划的潜在问题。利用全球监管机构的经验，我们培养了小说，有针对性的战略，以帮助您在目标市场中实现监管批准。

全面的监管咨询能力：

Need comprehensive Quality Systems support for FDA quality system regulation (QSR) and ISO 13485 compliance? No matter your size, we can scale the quality system to your goals, products and culture:

• 使用基于风险的方法整合法规和质量策略。
• Design and implement quality systems.
• 维护创新的质量策略，在产品生命周期期间，解决设备细微差别并与您的设备一起成长。
• Research regulatory body “hot buttons” for proactive risk-mitigation strategies to avoid regulatory sanctions.

质量体系。质量支持。

充分了解当前的健康经济和报销景观至关重要。监管清关仅使医疗设备公司有机会推销设备 - 它不确保付款。

综合方法支持通过市场后发射从早期概念的整个商业化旅程。提高您的市场验收机会，以获得更快的投资回报，我们的报销专家指导。

帮助您实现偿还的工具：

深思熟虑的试验设计和执行达到most efficient acquisition of sound scientific evidence on your device. Every trial has unique characteristics. Optimizing the appropriate study design to get the evidence you need, saves you both time and money during the operational phase of your project.

值得信赖，经过验证和尊重

我们的顾问在市场前和市场后的研究方面的深入经验可以快速查明改进或效率的领域，确定数据中的不寻常的发现，并与您合作，以期待和克服挑战。在您在产品生命周期的正确时间获取必要的证据时。

有时,成功的关键是改变中找到the business approach, not the product. That’s where our Device Consulting solutions come in. Our savvy medical device strategy advisors know the ins and outs of the new value-driven health economy and how to navigate through today’s marketplace landscape – and landmines. We can examine every detail of your development process to uncover opportunities, reduce cost and improve timelines.