Medical Devices

As a trusted medical device Regulatory consulting firm, for nearly a decade, Freyr has been setting the industry standards in assisting Medical Device and IVD companies worldwide for end-to-end Regulatory needs and device registration.

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    Customers
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    Projects
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    CER & PER Support
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    Regulatory Strategy Projects
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    Product Categories
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    EU MDR Transition Products
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CDSCO Extends License Opportunities

Unlock the "06-month" extension perk, right now!

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FDA eSTAR Compliance: The Key to Successful 510(k) and De Novo Submissions

We offer end-to-end support for successful eSTAR compliance

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It’s Time to Switch Over: Make the Switch from the 510(k) eCopy to the Obligatory eSTAR Template

Elevate your submissions process

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Simplify Global Compliance with MDSAP

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Ensure Seamless SaMD Registration Compliance in the US

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Overview
 

Medical Device Regulatory Consulting

Freyr, as a proven Regulatory partner, provides end-to-end Medical Device Regulatory services that span across decoding Medical Device classification, compiling Device documentation, Medical Writing, Device Registration and acting as an in-country representative. We customize the process with respect to service and software assistance for end-to-end device approvals. With our presence across the continents, Freyr offers Regulatory services for market entry and Regulatory compliance across all regions. Our dedicated team consist of a mixed pool of expertise offering one-stop solution for all the Regulatory needs.

Medical Device Regulatory Expertise

Navigating Regulations, Ensuring Innovation: Your Trusted Medical Devices Regulatory Experts

  • Market Access

    Implementing strategies to navigate regulatory, reimbursement, and distribution hurdles to effectively introduce products or services into target markets.

     

  • Regulatory Affairs

    Ensuring compliance with regulations to guarantee the safety and efficacy of medical devices for patient use.

     

  • Clinical & Performance Evaluation

    Rigorous assessment of medical device safety, efficacy, and performance to meet regulatory requirements and ensure suitability for use.

     

  • Quality, Compliance, & Audit

    Structured framework ensuring consistent quality and compliance across processes, products, and services within an organization.

     

  • Digital Health

    Digital Health/SaMD: Software serving medical purposes, offering diagnostic or therapeutic solutions through digital technology.

     

Country-specific Medical Device Regulatory Consulting

Operating across continents, Freyr Solutions has established a strong global presence. With regional expertise and a deep understanding of local regulations, we deliver tailored solutions in key markets worldwide.

Contact Us for Medical Device Regulatory Expert Guidance and Support

Freyr's Approach to Medical Device

In the intricate Medical Device’s Regulatory landscape, classification stands as a fundamental step in market entry and compliance. Understanding the nuances of the classification criteria set by Regulatory authorities worldwide is crucial for manufacturers seeking to bring their products into global markets. From the United States Food and Drug Administration’s (US FDA’s) classification system to the criteria outlined in the European Union Medical Device Regulation (EU MDR), accurately determining the classification of a device based on its intended use and inherent risks is paramount. Through meticulous analysis and adherence to Regulatory guidelines, manufacturers can ensure that their devices are appropriately categorized, paving the way for smoother processes and ensuring patient safety. Navigating the complexities of medical device classification requires expertise and attention to detail, which guide manufacturers through the Regulatory maze with precision and confidence.

The medical device industry faces numerous Regulatory challenges that impact product development, market access, and patient safety. One of the major hurdles is the constantly evolving Regulatory landscape, characterized by frequent updates to regulations and standards across markets. Keeping abreast of these changes and ensuring compliance with the varying requirements can be a complex and resource-intensive task for manufacturers.

Another significant challenge is the lack of harmonization among Regulatory frameworks across the globe. Regional variations in Regulatory requirements can lead to delays in market approvals and increased costs for manufacturers seeking to enter multiple markets simultaneously. Thus, harmonizing regulations across regions remains a key priority for facilitating market access and streamlining Regulatory processes. In fact, Regulatory agencies are placing greater emphasis on conducting Post-market Surveillance (PMS) and gathering Real-world Evidence to monitor the safety and efficacy of medical devices throughout their lifecycle.

We leverage our industry insights to anticipate Regulatory changes, providing strategic guidance to navigate the shifting landscape. From evolving compliance requirements to novel technological advancements, we empower our customers to adapt and thrive. Freyr’s unwavering commitment to staying ahead of Regulatory trends positions our customers for success, allowing them to focus on innovation while we navigate the complexities of compliance, ultimately facilitating a smoother journey through the regulatory maze.

Our seasoned professionals offer strategic guidance, ensuring that you not only meet Regulatory requirements but also seamlessly integrate them into product development. We collaborate closely with our customers to help them develop comprehensive Regulatory strategies that align with their business goals, thereby facilitating a smooth market approval process. Freyr’s commitment to excellence empowers customers to navigate the Regulatory landscape with confidence, knowing that they have a reliable partner dedicated to their success.

Country-specific Regulatory standards pose challenges in terms of product submissions and documentation, necessitating tailored Regulatory solutions. These factors highlight the importance of developing customized strategies that can effectively address the unique requirements of each market. By implementing tailored solutions, manufacturers can streamline their registration process, ensure accurate labeling, and meet country-specific Regulatory requirements, ultimately facilitating market access and product commercialization on a global scale.

Whether it is navigating complex Regulatory pathways, overcoming market access barriers, or addressing specific compliance requirements, Freyr offers solutions tailored to meet the unique needs of each customer. Our proactive approach ensures that manufacturers can confidently navigate Regulatory challenges, streamline the approval process, and bring safe and effective medical devices to the market. You can trust our commitment to delivering tailored Regulatory solutions that optimize compliance, minimize risks, and drive success in the dynamic medical device industry.

Post-market Surveillance (PMS) is a critical aspect of medical device regulation, aimed at monitoring the performance and safety of devices once they are placed on the market. Regulatory authorities worldwide require manufacturers to establish robust surveillance systems that can promptly identify and address any issues that may arise after the commercialization stage. This includes monitoring adverse events, conducting post-market studies, and maintaining open lines of communication with regulators and healthcare professionals. By diligently tracking real-world data on device performance and patient outcomes, manufacturers can proactively identify potential concerns and accordingly take corrective actions to safeguard patient safety. PMS activities play a pivotal role in ensuring the continued safety and efficacy of medical devices throughout their lifecycle, reinforcing public confidence in Regulatory systems and promoting patient welfare.

Freyr’s PMS capabilities not only help meet Regulatory requirements but also enhance the overall lifecycle management of medical devices, facilitating sustained success in the market. With Freyr as your Regulatory partner, you can navigate the complexities of PMS with vigilance and assurance.