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

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


We support your company’s regulatory agency meetings by preparing briefing documents and meeting requests, conducting preparatory sessions and facilitating meetings with the FDA and other regulatory bodies. We provide strategic and tactical support for medical device panel meetings, in addition to Q-submission and pre-submissions.

 

Premarket Submission Support


MEDITRIAL offers a range of services throughout the pre-market submission development process. This includes documentation review, submission writing or other document preparation and scientific literature review, as well as FDA and regulatory response strategy and communications.

 

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

Our integrated team of medical writers, biostatisticians, regulatory specialists, and clinical experts working all over Europe, will support you in conducting your clinical trial by analyzing and interpreting data and ultimately packaging your trial to obtain an expedited CE mark.

Risk Management

Having difficulties in maintaining your clinical trials compliant with ISO 14071? Meditrial makes it easy. With our global experts we will guide you through all the steps for a successful implementation of a risk-management process.

Clinical Evaluation

Guarantee the clinical safety and performance of your medical device thanks to our highly specialized team work. We shall carry out the assessment and analysis of clinical data pertaining to your clinical device.

Post Market Surveillance

Make it simple. Trust our experts in meeting post-market surveillance (PMS) requirements to guarantee compliance with international and harmonized standards in observance with all applicable regulations regarding the European Medical Devices Directives.

MDR AND IVDR ACADEMY

  • CLINICAL EVALUATION REPORT (CER) is essential to obtain the CE Mark based on a scientifically solid methodology.
  • The same report can be used for due diligence, FDA submission and global regulatory approvals in other countries.
  • Meditrial CERs have gained approval for 100+ Innovative devices, including high risk class III products involving software, hardware, animal tissue, drug combination and more.

The Meditrial Academy training program allows easy understanding of the steps to produce the CER and superior collaboration.