Freyrsolutions

Freyr has been a trusted partner for the FDA medical device establishment registration services for medical devices and 510(k) submissions. We specialize in assisting medical device manufacturers with the registration process and ensuring compliance with US FDA regulations and requirements. Our team of Regulatory experts will guide you through the intricacies of US FDA medical device registration and assist you in navigating the complex Regulatory landscape and achieving successful registration for your medical devices.

At Freyr, we understand the importance of a successful US FDA FDA 510(k) submission for bringing your medical device to the market. Our expert team specializes in providing comprehensive support throughout the entire US FDA 510(k) submission process. With our knowledge and expertise, we ensure that your submission meets all the necessary 510(k) submission requirements for FDA 510(k) clearance. Our team of Regulatory experts will support and guide you through the compliant Regulatory pathway and maximize your chances for a successful FDA 510(k) submission.

At Freyr, we specialize in providing comprehensive 510(k) services to assist you in navigating the FDA 510(k) clearance process for your medical devices. Our team of Regulatory experts is well-versed in the intricacies of FDA regulations, ensuring a smooth and successful journey toward obtaining the FDA 510(k) clearance. Explore our wide range of services tailored to assist you with your 510(k) medical device approval process.
There are 3 types of 510(k) applications that can be submitted to the US FDA for device evaluation and approval.

For over a decade, Freyr has been a trusted partner for the US FDA 510(k) consulting services. Our team of experienced consultants specializes in providing comprehensive guidance and support throughout the FDA 510(k) clearance process. With their deep understanding of the FDA regulations and requirements, our expert FDA 510(k) consultants ensure that your medical device submission meets all the necessary criteria for a successful clearance. Freyr’s focus on comprehensive US FDA Regulatory strategy and the up-to-date US FDA new amendments will help you navigate the complex Regulatory landscape

US FDA has various mechanisms to facilitate interaction with the Agency regarding various applications that can be submitted for medical devices of varied risk classes. The early engagement with the Agency is facilitated through the request for feedback or a meeting with the US FDA under the “FDA Q-Submission Consulting Program”. This program enables interaction with the FDA on study and data considerations to improve the quality of submissions, reduced review timelines, and avoidance of unnecessary pre-clinical or clinical studies. Furthermore, manufacturers can leverage the FDA pre-submissi

The USFDA Premarket Approval (PMA) process is one of the device registration pathways provided by the US FDA, primarily designed for FDA Class III medical devices. The FDA PMA approval process for Class III devices entails meticulous scientific and regulatory evaluations to assess the medical device's safety and efficacy, ensuring the highest standards are met prior to the market authorization.
Device manufacturers must submit a PMA application if the device:
Is novel.
Belongs to a high-risk class.
Cannot be found in the Product Classification Database.
Is not substantially equivalent (N

The US FDA's medical device classification system in the United States of America predominantly depends on a predicate system for classifying medical devices. That is, drawing comparisons to legally marketed devices and determining the classification of I, II, or III based on the risk. To enable manufacturers, to determine the classification of their devices or to search for Substantially Equivalent (SE) of their devices, FDA provides a Medical Device classification database. In cases where the SE is not found, manufacturers can explore alternative options by submitting an FDA 513(g) Submissi

The Regulatory world is constantly changing, and to keep pace with the same compliantly, opting for medical device Regulatory consulting stands as a key for device and IVD companies. For over a decade, Freyr has been instrumental in keeping its customers aware of the updated regulations by providing compliant end-to-end Medical Device Regulatory Services. As a medical device Regulatory consulting services organization, Freyr ensures to bring safe, high-quality, and compliant medical devices and IVDs into the global markets faster. Our team of Regulatory experts will navigate the Regulatory co

Freyr iREADY is a technology based cosmetics ingredients database platform that enables manufacturers in management of cosmetics ingredients and product formulae in global markets. Freyr iREADY is a technology based cosmetics ingredients database platform that enables manufacturers in management of cosmetics ingredients and product formulae in global markets. Freyr iREADY is a technology based cosmetics ingredients database platform that enables manufacturers in management of cosmetics ingredients and product formulae in global markets. Freyr iREADY is a technology based cosmetics ingredients

Freyr Submit PRO, an eCTD publishing software that allows the user to track, modify and review of eCTD documents until submissions to Health Authorities. Freyr Submit PRO, an eCTD publishing software that allows the user to track, modify and review of eCTD documents until submissions to Health Authorities. Freyr Submit PRO, an eCTD publishing software that allows the user to track, modify and review of eCTD documents until submissions to Health Authorities. Freyr Submit PRO, an eCTD publishing software that allows the user to track, modify and review of eCTD documents until submissions to Hea

Freyr provides regulatory intelligence support for Lifesciences organizations for compliant market entry of products across the globe. Freyr provides regulatory intelligence support for Lifesciences organizations for compliant market entry of products across the globe. Freyr provides regulatory intelligence support for Lifesciences organizations for compliant market entry of products across the globe. Freyr provides regulatory intelligence support for Lifesciences organizations for compliant market entry of products across the globe. Freyr provides regulatory intelligence support for Lifescie

Freyr Artwork 360 is an easy-to-use Artwork PLM Tool that manages Artwork Workflow Management, Artwork Version Tracking, Artwork Proofing & Review, Artwork Digital Asset Library, Artwork Reports and Collaboration Between Stakeholders ect..

Freyr iREADY is a technology based food ingredients database platform that helps manufacturers in management of foods ingredients and product formulae in global markets.

Freyr provides cosmetic regulatory services in Brazil as per ANIVSA during cosmetic product registration, classification, Notification, formulation, claims review, CPSR and technical dossier compilation

Freyr provides food regulatory services in Brazil as per ANIVSA and CTCAF during food product registration, food classification, formulation, ingredient assessment, technical dossier compilation and submission

Freyr provides medical device regulatory services in Brazil during medical device registration, medical device classification and market entry as per ANVISA regulatory requirements

Freyr provides pharma/Medicinal product regulatory services in Brazil as per ANVISA during Medicinal Product Registration, classification, Market authorization and Dossier Gap analysis

Freyr provides regulatory services and solutions in Brazil to comply with ANVISA for pharmaceuticals, medical device, cosmetics and food supplement manufacturer companies

Freyr provides regulatory services and solutions in India to comply with CDSCO regulations for pharmaceuticals, medical devices, cosmetics, and food supplements manufacturing companies.

Freyr provides End-to-End Regulatory Solutions & Services in Australia to the Pharma Innovator, Generics, Biologics, Medical Device, Food Supplements, and Cosmetic Companies to comply with TGA Regulations.