评论 9
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D
8 几个月前

We have been working with Medreg consulting, llc f...

We have been working with Medreg consulting, llc for several months, and the experience has been outstanding. Their team is highly proactive and responsive, always making sure our needs are met. They have deep knowledge in medical regulatory matters and offer valuable guidance. We are extremely satisfied with their services and look forward to a continued partnership.

L
12 几个月前

I recently utilized the services of a medical regu...

I recently utilized the services of a medical regulatory consulting firm for my business needs. The experience was really great, and I found the assistance provided to be exceptional. The consultants were highly knowledgeable and provided practical solutions to our regulatory challenges. Their expertise helped us streamline our processes and ensure compliance. I would definitely recommend their services to others.

G
1年以前

Medreg consulting, llc is an excellent company to ...

Medreg consulting, llc is an excellent company to work with. Their expertise in medical regulatory matters is commendable. They provided us with valuable guidance and support, helping us navigate through complex regulatory requirements. The team at Medreg is highly knowledgeable and professional. They go above and beyond to ensure client satisfaction. I highly recommend Medreg consulting for all your medical regulatory needs!

S
1年以前

💯 Medreg consulting, llc is an exceptional company...

💯 Medreg consulting, llc is an exceptional company in the medical regulatory field. Their team is dedicated, knowledgeable, and always ready to help. We have benefited greatly from their expertise and guidance, ensuring compliance with relevant regulations. Their professionalism and attention to detail sets them apart from others. Highly recommended!

S
1年以前

👌 Medreg consulting, llc provides top-notch servic...

👌 Medreg consulting, llc provides top-notch services in the medical regulatory field. Their team is passionate, knowledgeable, and always willing to go the extra mile. They have helped us achieve compliance with ease, and their expertise has been instrumental in our success. We highly recommend their services to anyone in need of medical regulatory assistance!

S
1年以前

👍 Medreg consulting, llc is doing a fantastic job ...

👍 Medreg consulting, llc is doing a fantastic job in the medical regulatory field. Their team is always ready to assist and provide valuable insights. They have helped us immensely in navigating complex compliance requirements. Their expertise combined with a customer-centric approach makes them one of the best in the industry. Highly recommended!

B
1年以前

Medreg consulting, llc has been an incredible part...

Medreg consulting, llc has been an incredible partner in our medical regulatory journey. Their expertise in the field is unparalleled, and they consistently deliver exceptional results. Their team is highly professional, reliable, and goes above and beyond to ensure client satisfaction. We are grateful for their support and highly recommend their services!

A
1年以前

I recently worked with a consulting firm specializ...

I recently worked with a consulting firm specialized in medical regulatory matters. The assistance provided was of high quality and extremely helpful. The consultants demonstrated a profound understanding of the regulatory landscape, allowing us to navigate complex requirements effectively. I would highly recommend their services to anyone in the healthcare industry.

B
1年以前

Medreg consulting, llc has been a valuable partner...

Medreg consulting, llc has been a valuable partner for our business. Their expertise in medical regulatory matters has been instrumental in achieving compliance. We have found their team to be highly professional and reliable. They understand the unique challenges faced by healthcare companies and provide tailored solutions. We are really satisfied with their services.

关于Medreg consulting, llc

MedReg Consulting, LLC:您决定性的医疗器械/家庭法规事务咨询

MedReg Consulting, LLC 是一家领先的监管事务咨询公司,专门为医疗器械和家庭保健公司提供全面而果断的监管解决方案。凭借多年的行业经验,MedReg 已成为寻求驾驭复杂的法规遵从性世界的企业值得信赖的合作伙伴。

在 MedReg,我们了解驾驭监管环境可能具有挑战性且耗时。这就是为什么我们提供一系列旨在帮助我们的客户快速有效地实现其目标的服务。我们的专家团队对 FDA 法规、国际标准和行业最佳实践有着广泛的了解。我们与客户密切合作,制定满足他们独特需求的定制策略。

我们的服务

我们提供范围广泛的服务,旨在帮助我们的客户快速有效地实现他们的目标。我们的服务包括:

1) 监管战略制定:我们与客户合作制定满足其独特需求的定制战略。我们的团队将评估您的产品组合,识别潜在风险或挑战,并就如何最好地应对监管环境提供指导。

2) 上市前提交:我们协助上市前提交的所有方面,包括 510(k)、PMA 申请、IDE(研究器械豁免)、De Novo 请求(针对新器械)、CE 标记(针对欧盟市场准入) ), 加拿大卫生部提交(加拿大市场准入)。

3) 上市后合规:我们为不良事件报告 (MDR/MDV)、召回/纠正措施/现场安全纠正措施 (FSCA) 等上市后活动提供支持。

4) 质量体系实施和审核:我们协助质量体系实施和审核,包括 ISO 13485 认证准备和审核。

5) 培训与教育:我们提供与医疗器械法规相关的各种主题的培训,例如 FDA 对标签声明或临床研究的要求。

为什么选择 MedReg Consulting, LLC?

1) 专业知识:我们的专家团队对 FDA 法规、国际标准和行业最佳实践有着广泛的了解。

2) 定制解决方案:我们与客户密切合作,制定满足他们独特需求的定制策略。

3) 及时高效的服务:我们理解及时高效服务的重要性。这就是为什么我们努力在不影响质量的情况下为我们的客户提供快速的周转时间。

4) 有竞争力的价格:我们为所有服务提供有竞争力的价格,同时不影响质量。

5) 可靠的记录:我们可靠的记录不言自明。我们已帮助众多公司实现其产品的合规性和市场准入。

结论

总之,MedReg Consulting, LLC 是您决定性的医疗器械/家庭保健法规事务咨询合作伙伴。拥有多年的行业经验和精通FDA法规、国际标准和行业最佳实践的专家团队;我们相信我们可以帮助您快速有效地实现您的目标。立即联系我们,详细了解我们如何帮助您满足监管需求!

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Medreg consulting, llc

Medreg consulting, llc

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