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.

  • 420

    +

    Medical Device Customers

  • 1200

    +

    Projects

  • 1450

    +

    Device Approvals

  • 99%

    +

    First-time-right Submission

  • 120

    +

    Markets

  • 70

    +

    Product categories supported

  • 350

    +

    High Risk Device Approval

  • 500

    +

    Moderate Risk Device Approval

  • 600

    +

    Low Risk Device
 

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 pathway to effectively introduce your medical devices into target markets. .

     

  • Regulatory Affairs

    Ensuring compliance with regulatory requirements to ensure the safety and efficacy of medical devices for patient use.

     

  • Clinical & Performance Evaluation

    Includes a range of medical writing services to ensure smooth entry into your target market.

     

  • Quality, Compliance, & Audit

    QMS solutions to meet the international regulatory standards requirement.

     

  • Digital Health

    Regulatory compliance services for SaMD ensure software meets all required standards and regulations for safety and effectiveness.

     

  • Human Factors Engineering 

    Enhances the safety and usability of your medical devices, helping you meet and exceed regulatory standards, and ensuring your medical device is user-centered and compliant.

     

  • Global Regulatory Intelligence

    Master the complexity of Medical Devices regulations by harnessing the power of 24000+ insights spanning classifications, labelling, registrations, approvals and post-market surveillance.

     

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.

Americas

LATAM

Asia Pacific

Middle East & Africa

Europe

Contact Us for Medical Device Regulatory Expert Guidance and Support

Send Us a Request

The Regulatory Journey of a Medical Device Company: From Concept to Post-Market

Concept Phase: Navigating Regulatory Ambiguity and Market Complexity

Medical device companies often begin with a groundbreaking idea — a novel diagnostic tool, wearable monitor, or software-driven application. But turning that innovation into a marketable product brings an immediate obstacle: Regulatory uncertainty.

  • Problem: Companies face challenges in determining how their device will be classified globally. Is it a Class I or Class III device in the U.S.? What about in the EU, Japan, or the market you are trying to enter?
  • Solution: A Regulatory consultation and global risk classification help define the pathway forward. This includes understanding global Regulatory frameworks like FDA, MDR, and IVDR, and mapping risk classification accordingly.

Additionally, businesses need to know what claims their competitors make and how to position their product without overstepping legal boundaries.

  • Competitor claims analysis and due diligence ensure companies don’t walk into legal traps or make unverifiable claims.

Engaging with Regulatory bodies becomes a minefield for complex or combination products (e.g., drug-device combos or AI-based SaMD).

  • Pre-submission strategies ensure effective dialogue with the FDA or Notified Bodies, preventing costly missteps.

Understanding Regulatory intelligence and market-entry strategies allows companies to focus their efforts on the right markets with the right approach.

Planning Phase: Establishing a Robust Regulatory Foundation

With concept clarity, planning must focus on operational readiness and regulatory structure. Many organizations lack scalable documentation systems at this stage.

  • Challenge: Absence of standardized templates, document structures, or traceable quality frameworks.
  • Challenge: Uncertainty regarding applicable regulatory standards and user needs.

Freyr’s Solutions:

  • Creation of tailored regulatory templates, checklists, and file structures that align with FDA, MDR, IVDR, and ISO expectations.
  • Proactive identification of applicable standards (e.g., ISO 13485, ISO 14971, IEC 62304) and detailed documentation of user requirements, ensuring design inputs are appropriately captured and justified.

Design Phase: Ensuring Documentation and Risk Alignment

As product development progresses, design documentation and risk management become critical compliance elements. Gaps during this phase are frequently uncovered during audits or technical file reviews.

  • Challenge: Incomplete or improperly structured design control documentation.
  • Challenge: Misaligned or insufficient risk management and usability engineering documentation.
  • Challenge: Hidden documentation gaps that delay submissions.

Freyr’s Solutions:

  • Development and remediation of design control documents (Design & Development Plan, Inputs, Outputs, Reviews) that establish end-to-end traceability.
  • Comprehensive risk management files (per ISO 14971) and usability engineering documentation (per IEC 62366), demonstrating product safety and human factors compliance.
  • Execution of comprehensive gap assessments to identify and address deficiencies prior to formal submissions.

Validation Phase: Demonstrating Performance, Safety, and Compliance

Validation is a critical checkpoint where many organizations experience bottlenecks. Without properly structured evidence, Regulatory approvals may be delayed or denied.

  • Challenge: Incomplete or non-compliant technical documentation.
  • Challenge: Underdeveloped clinical, biological, or performance evaluation reports.
  • Challenge: Weak validation protocols for software, packaging, or sterilization processes.

Freyr’s Solutions:

  • Authoring and assembly of compliant technical documentation for medical devices (MD), in vitro diagnostics (IVD), software as a medical device (SaMD), and drug-device combinations (DDC).
  • Preparation of GSPR checklists, Declarations of Conformity (DoC), and Design History File (DHF) updates.
  • Development of robust clinical and biological evaluation reports (BRA, BEP, BER, CEP, CER, CEAR) aligned with EU MDR/IVDR and MEDDEV guidance.
  • Execution of thorough validation protocols for all critical systems, including software, packaging, sterilization, and labeling.

Launch Phase: Securing Regulatory Approvals and Market Access

At this pivotal stage, Regulatory readiness determines time-to-market. A lack of strategic guidance or submission experience can result in costly delays or rejections.

  • Challenge: Unfamiliarity with global Regulatory submission requirements.
  • Challenge: Inadequate preparation for MDR/IVDR transitions or market-specific submissions.
  • Challenge: Lack of specialized expertise for digital health products or device software.

Freyr’s Solutions:

  • Support for global Regulatory submissions including 510(k), PMA, CE Marking, UKCA, Swiss medic, and Emergency Use Authorizations (EUA).
  • Expertise in MDR/IVDR transition planning, submission remediation, and compliance gap closure.
  • Specialized submission strategies for SaMD, MDSW, and procedure packs with complex classification or intended use.
  • End-to-end support for Regulatory authority and Notified Body interactions, including query responses and deficiency remediations.

Post-Market Phase: Sustaining Compliance and Managing Change

Post-market responsibilities are often underestimated. Yet, failure to maintain documentation, investigate complaints, or submit variation filings can lead to serious Regulatory consequences.

  • Challenge: Outdated biocompatibility assessments or QMS documentation.
  • Challenge: Lack of a strategy for recertification or technical file maintenance.
  • Challenge: Unmanaged product or process changes impacting compliance.

Freyr’s Solutions:

  • Periodic biocompatibility reviews and QMS gap assessments to ensure ongoing alignment with updated standards and guidance.
  • Development of a structured technical file maintenance and re-certification strategy, reducing rework and ensuring audit readiness.
  • Management of clinical investigations and variation filings in compliance with authority expectations.
  • Performance of change impact analyses and notification strategies to manage updates, manufacturing changes, and product enhancements.

From initial strategy to sustained compliance, Freyr ensures your medical device journey is globally aligned, audit-ready, and market-driven.