IVDs

IVDs

HMC experts will work with your team on a global scale to fast-track the commercialization of IVDs products. With our in-depth knowledge of current requirements, you will understand precisely the complex legal challenges that IVDs manufacturers sometimes face. However, our goal is not for you to purely understand the IVDs, but to make your growth strategy easier and more efficient .

Whether you're supporting IVDs regulatory reviews and submissions, developing IVDR-compliant technical files, designing and managing clinical trials, or building an ISO 13485-compliant quality system: 2016 and 21 CFR part 820… we both help you.

We need whatever needs you may require, and we guarantee high quality and cost-effective results for you.

IVDs Lifecycle 1

Product development

Corate with HMC for valuable advice and input. Let us accompany and assist you from the very beginning of your product development. Your steps will be solid and cost-effective when the project is followed with us from the top. We help you synchronize workflow, regulation and quality by making sure your products are always comply with the required regulations.

Learn more about product development.

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Regulatory strategy

By having a well-thought out strategy, you will minimize risks and quickly pass important milestones

Learn more about Regulatory strategy.

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Clinical investigation

Help your clinical trials quickly succeed, and eliminate unnecessary errors. We help you develop studies in a timely and effective manner. We also create medical examination, survey sites, and produce records with accurate and transparent data

Learn more about Clinical investigation.

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Submit

We stay up-to-date with the latest regulations to help get your product submitted in a correct, timely manner with minimal returns and loss of time.

Learn more about regulatory submissions.

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Developing and ensuring the quality system

We rely on your system to create the most suitable management mechanism. Based on our proprietary approach, we implement the following: Compliant, Lean, Integrated, and Custom QMSs. We will maintain all elements to ensure this quality system.

Learn more about Developing and ensuring the quality system.

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Post-market surveillance

We will carry out after-market monitoring activities and issue the necessary warnings. Making sure your business is sustainable.

Learn more about Post-market surveillance.

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Headquarters

5 Penn Plaza, 19th Floor, New York, New York, 10001, United States of America

Contact Us

800 320-1438 info@hopkinsmedtech.com

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