Dalia Givony Regulatory & Clinical Consulting for Medical Deviceת | FDA Clearance & CE Mark, AMAR, Clinical Studies| Israel

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medical device strategy consulting

CREATIVE SOLUTIONS TO PAVE THE PATH TO THE MEDICAL DEVICE MARKET

Our Expertise
Professional, Creative & Flexible Support

The medical device industry is a fast-growing yet challenging space.

Constantly evolving regulatory environment requires an expert partner, helping you identify the regulatory requirements as well as plan and conduct clinical studies for your medical device, anticipate risks and address issues before they arise.

We are your partner from product concept to global marketing, deploying innovative strategy with on the ground insight, negotiate with FDA, CE Notified Bodies and other regulatory authorities. Asking the right questions and collaborate with your team to provide hands-on support and identify creative, yet compliant solutions for your challenges.

Medical device quality consulting

regulatory stretagy for medical device and IVD in US - FDA, EU - CE Mark, Israel- AMAR, Canada

Regulatory Strategy

US FDA regulation for medical device and IVD

CE mark for medical device and IVD according to EU MDD or MDR

Global registration of medical device and IVD

Global Registration

clinical study, strategy, design, clinical study file

analysis and management for medical device

fda regulatory consulting services

medical device fda consultant

FDA Clearance & CE mark

Expert Guidance & Submissions

With years of experience, we have the capabilities and expertise to take your business to the next level. We combine our insights and skills to create a cost - effective, risk based regulatory strategy to facilitate your company expansion into global markets. We’re proud to provide hands-on regulatory support through the product life cycle, from concept to post market stage, with specialization in FDA and CE regulations; resolving regulatory issues while communicating directly with FDA and other regulatory authorities.

medical device fda consultant

Clinical Studies

Plan & Execute

Looking to design a clinical study to support 510(k) submission or your CE technical file? Need help planning or executing your next post market clinical study to support marketing or regulatory requirements? Let us support you with our deep scientific & clinical knowledge and with our experience in planning and managing successful clinical studies in the most cost efficient, timely manner yet compliant way.

medical device fda consultant

Global Registration

Expand Your Potential Markets

Canada, China, Brazil, Japan, Mexico, Argentina and many other countries have their own regulatory requirements for medical devices. 510(k) clearance or CE technical file can be used as a strong basis for global product registration, though in some cases, compliance with other standards and regulations may be required by the authorities. We are here to help you identify the requirements as well as prepare the required reports while risk based, least burdensome approach is considered.

FDA's Breakthrough Devices Program

Dalia Givony

FDA's Breakthrough Devices Program

In Vitro Diagnostic (IVD) Tests - US FDA and EU Regulation

Dalia Givony

In Vitro Diagnostic (IVD) Tests - US FDA and EU Regulation

Post Market Surveillance (PMS) under the EU MDR

Dalia Givony

Post Market Surveillance (PMS) under the EU MDR

US FDA Regulatory Approach to Clinical Decision Support (CDS) Software

Dalia Givony

US FDA Regulatory Approach to Clinical Decision Support (CDS) Software

Consulting with FDA under the Pre-Sub process before submitting a 510(k)/ De Novo

Dalia Givony

Consulting with FDA under the Pre-Sub process before submitting a 510(k)/ De Novo

Labeling requirements for medical devices

Dalia Givony

Labeling requirements for medical devices

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