REGULATORY AFFAIRS.

FDA & EUROPEAN REGULATION SERVICES

GLOBAL REGULATORY STRATEGY AND APPROVAL SERVICES

Receive dedicated support in every stage of the technology lifecycle approval, maximizing compliance, performing correct tests.

Our team of medical, regulatory and technical experts will assist you to efficiently bring innovative medical devices, in vitro diagnostics and combination products to market.

FDA SERVICES
EUROPEAN SERVICES

FDA SERVICES

Your Regulatory Roadmap for FDA

Our strategic assessments of regulatory requirements address business needs for medical device, in vitro diagnostic and combination product market authorization. We offer evaluations of product classification, submission type, data requirements and timelines.

  • Gap Assessments
    We provide submission-readiness evaluations and remediation recommendations, including reviews of device labeling.

  • Preclinical Testing Support
    Receive regulatory input during design control, as well as regulatory guidance for device safety and performance testing plans, protocols and reports.

  • Due Diligence Assessments
    Evaluate regulatory documentation and status ahead of your company’s major acquisitions with the help of our experts.

Regulatory
Agency Meeting Support

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Premarket Submission Support

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Our services also include:

  • Breakthrough devices program support for developing and requesting expedited review pathways
  • Device classification via the 513(g) pathway
  • Investigational device exemption (IDE)
  • Premarket approval (PMA)
  • Humanitarian use device (HUD)
  • Humanitarian device exemption (HDE)
  • Premarket notification (510(k))
  • De novo classification requests
  • Request for Designation (RFD) and Pre-RFD
  • Device master file (DMF)

EUROPEAN SERVICES

EU MDR Preparation and Compliance

Navigate significant EU MDR changes with the help of our experts. Schedule training for your staff, receive regulatory and clinical support or request an audit to prepare for everything from device classification to new requirements for technical documentation and clinical evidence.

EU IVDR Preparation and Compliance

Receive an introduction to regulatory requirements for bringing an IVD to market in the EU. Our experts offer training and support to meet the new requirements for clinical evidence, post-market surveillance and economic operators, such as manufacturers, distributors and importers.

CE Mark
Roadmap

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Risk
Management

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Clinical
Evaluation

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Post Market
Surveillance

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MDR EXPERT SUPPORT

Europe’s new Medical Devices Regulation 2017/745 (MDR) is finally here and takes effect in May 2021. If you need help with MDR transition strategy, gap assessments, or simply getting up to speed quickly on the MDR requirements, check out our MDR Training and MDR Consulting options.

Our team is here to help.

Contact Us online!