Devices and Diagnostics

Service overview

Real Regulatory has a proven track record in all aspects of medical technology. We will work with you to design and implement a competitive and cost-effective regulatory strategy, prepare and submit a comprehensive technical file/design dossier application and act as your intermediary with the notified body or regulatory authority.

Medical Device Consulting Services

General Services

  • Regulatory and Technical review and consulting
  • Preparation and submission of registration for product applications
  • Preparation and submission of Clinical Trial Applications
  • Medical device vigilance and reporting systems
  • Regulatory and manufacturing compliance
  • Strategic and regulatory planning
  • Auditing of Quality & Regulatory systems to ensure compliance
  • Quality Management System Integration
  • Regulatory/Quality Gap Analysis
  • Interpretation of guidance documents and legislation
  • Assistance with device labelling requirements
  • Liaison with Regulatory Authorities/Notified Bodies
  • Determination of product classification
  • Risk Management (ISO 14971)

European Services

  • Preparation and submission of EU Regulatory documentation including:
    • Technical Files
    • Design Dossiers
  • Liaison with EU Competent Authorities and Notified Bodies
  • Implementation of MDR and IVD requirements
  • Determination of product classification
  • Pre-/post-inspection audits to ISO 9001, ISO 13485
  • Standards Update
  • Company Specific Training
  • Provision of European Authorised Representative Services

US Services

  • Pre-market Notification 510 (k)
  • New Products
  • Product/Process changes
  • New Intended use
  • Pre-market Applications (PMA)
  • Establishment Registration
  • US FDA Liaison including pre-submission meeting if required
  • Provide medical device classification and pre-market strategy
  • Monthly/Quarterly Medical Device Reporting
  • Post-Market Requirements
  • Perform regulatory GAP analysis
  • Compliance program development
  • GMP Quality System expertise

Typical projects

Project:  Clinical Evaluation of a class IIb medical device
Client: International manufacturer of specialist medical equipment
Challenges: Generation of a clinical evaluation report for one device which expanded to include a final of six products under extremely tight and inflexible timelines for submission to the Notified Body.
Our Solution: Clinical Evaluation was conducted by a competent and experienced consultant in the literature review of clinical data. The project was effectively managed to encompass all six products with support from the wider Real Regulatory team. Technical and clinical input from the client and clinical expert, respectively, were successfully managed to facilitate timely submission to the Notified Body.

Project: Submission to Notified Body for a Class III medical device which incorporates an ancillary drug substance (combination device)
Client: A large global provider of medical devices used in a variety of therapeutic areas
Challenges: The project relied on Real Regulatory’s experience and awareness of the overall device development strategy, timelines and collective technical documentation requirements originating from various parties (e.g. device manufacturer, drug substance manufacturer, drug product manufacturer, etc.). Submission timelines to the Notified Body were tight. As the device included an (integral) ancillary drug substance understanding the pharmaceutical documentation requirements for the consultation process with the Competent Authority was critical.
Our Solution: Real Regulatory provided experienced experts in pharmaceutical drug development and medical device technology from the outset of the project. Frequent strategy development meetings were held with the client and relevant parties. This ensured that any potential developmental hurdles were anticipated and quickly overcome. In addition regular contact was maintained with the Notified Body and consulting Competent Authority to ensure that all submission requirements and key milestones were met within the desired time-lines. A positive decision notification was recently received from the consulting Competent Authority.

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