Services

Regulatory

An Integrative & Comprehensive Approach

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Our submission experience encompasses pre-submissions, 510(k), IDE, PMA, De Novo, Reports for PMAs and IDEs and the preparation of meeting materials.

WCRO’s Regulatory team have extensive experience working for the FDA and Notified Bodies, as well as within the private industry and have biomedical engineering, biostatistical, material science, medical writing and clinical backgrounds.

Our integrative and comprehensive approach to the regulatory process assists you through the developmental process with the end-goal of delivering your device through the regulatory and reimbursement process expediently, efficiently and economically.

Regulatory Services

Services

  • Clinical Evaluation Reports
  • Clinical Trial Protocol Development
  • FDA Marketing & Labeling Compliance
  • FDA Meeting Preparation
  • FDA Submissions & Reports
  • Preclinical Strategy and Development
  • Strategic Regulatory Advisory Services

Our Therapeutic Specialties

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Cardiovascular

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Dental

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Gastroenterology & Urology

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General & Plastic Surgery

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Orthopedics & Spine

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Wound Care & Dermatology

Frequently Asked Questions

What is a Clinical Evaluation Report?

A clinical evaluation report, CER for short, documents the finding and conclusions of a clinical evaluation of your medical device. A CER consists of analyzed clinical data that was collected either from a clinical investigation of your device or the results of other studies on substantially equivalent devices. It is a part of your larger technical file or design dossier and often includes the following elements:

  • Device and manufacturer name and information
  • Concise physical and technical device description and intended application
  • Outline of intended therapeutic or diagnostic claims
  • Clinical evaluation and data types
  • Summary of clinical data and review
  • Describe analyses used to assess performance, safety and relevance/accuracy of product literature
  • Conclusions about safety, performance and conformity

How should I prepare for a successful FDA meeting?

It is always recommended that you work with an experienced CRO if you do not have a team member with FDA meeting experience; however, here are a few tips for a successful FDA meeting:

  • Include a proposed agenda with focused questions and a background package or briefing document with your position, an outline of product data and your development recommendation.
  • Make sure you have the right people at the table. Include meeting attendees who work directly in the development and testing of your device.
  • Practice your message and be punctual
  • Manage your allotted time carefully to ensure that your pacing through your questions and information so time does not run out before you have what you need.

What is the difference between a device label and device labeling?

Section 201(k) of the Federal Food, Drug and Cosmetic Act (FD&C Act) defines ‘label’ as a ‘display of written, printed, or graphic matter upon the immediate container of any article…’ while ‘labeling’ is defined as ‘all labels and other written, printed, or graphic matter (1) upon any article or any of its containers or wrappers, or (2) accompanying such article’ at any time while a device is held for sale after shipment or delivery for shipment in interstate commerce. Consult WCRO to ensure that you are making the correct representations in the correct places.

Contact WCRO For Effective Regulatory Guidance