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WEB DEMO
  • Home
  • About
    • Our Story
    • The Executive Team
    • Why CRFWEB?
    • Contact
      • Our locations
      • Europe – UK Office
      • India
    • Careers
    • Security and compliance
  • Solutions
    • The EDC process
    • eCRF
    • MedDRA
    • Randomization
    • ePRO
    • eDiary
    • The Clindox App
    • Clindox eLab
    • Innovations Hub
  • Medical Devices
    • Medical Devices Home
    • Introduction to Medical Device Investigations
    • Pre-Licence Investigations
    • Post-Market Investigations
    • Technologies for Investigations
      • technologies for medical device clinical trials
      • ePRO & eDiary for medical device clinical trials
      • EDC for medical device clinical trials
      • The Clindox App for medical devices
      • Clindox eLab
    • Medical Device Regulations
    • Medical Device Resource Centre
    • Clindox for IVD Studies
  • Other Sectors
    • Pharma-Biotech
    • Nutraceuticals
    • CROs
    • Academia
    • Clindox for IVD Studies
  • News

Pre-licence investigations for Medical Devices

Medical equipment on table. Blue stethoscope and tablet on white background.

CRFWEB is a fast to set-up fully functioning, flexible, reliable and cost-effective SaaS eClinical platform to manage medical device clinical studies. It’s a critical part of the strategy to get your medical device products to market.

A Proven Specialist in Medical Device Clinical Data

CRFWEB‘s focus and experience in medical device studies means our software platform provides all the tools you’re likely to need to meet your pre-licence regulatory requirements. CRFWEB will also provide you with the opportunity to discover new scientific, technical and operational insights derived from your data. 

  • All your Compliance and regulatory requirements supported 

    FDA (CDRH) 21CFR 807 and 814, GDPR, HIPAA, MEDDEV and the transition to IMDR and IVDR

  • Device study specific features 

    Device logs: AE, ADE, SAE, SADE, USADE, randomization for sham controlled studies

  • The features you need, all integrated

    SDV, SDTM, Medical coding (MedDRA), ePRO & eDIARY (browser-based entry and via the Clindox App), Randomization and Trial Supply Management

  • What technologies do we offer for data capture?

    Browser or app-based entry, researcher or subject-led data entry. You choose. Click here to read more.

Learning more on pre-market regulatory impact

It’s important to have a thorough understanding of the pre-market MDR regulations and their global impact. Our info sheets and articles will get you up to speed in no time at all. Below you will find links to 2 useful overview pages and you can access all info sheets and articles by visiting the Medical Device Resource Centre.

  • Info Sheet – Medical Device Clinical Studies explained

    What protocol options are available for Medical Device Studies? How are they supported by technology and what are the design considerations?

  • Info Sheet – Pre-market Studies

    A guide to Pre-Market Studies under EU MDR.

Paper, spreadsheets, legacy databases or eCRF?

If you have current data in paper, spreadsheet format or legacy databases, we can help. With CRFWEB we can develop an eCRF from that and import data, as appropriate allowing you to benefit from the efficiencies offered by our SaaS solution. If you are considering using spreadsheets as an alternative to an eCRF however, we strongly recommend you take advice first. An eCRF designed correctly on an eClinical platform like CRFWEB, with the requirements of Medical Device studies in mind, will make your study manageable and reportable.

rsz_meeting_demands_of_medical_device_clients-1

Understanding the demands of Medical Device Data Capture and Management

 

CRFWEB is being used by numerous medical device clients in a number of countries. We understand the needs of medical device investigations. We have a template library of relevant medical device adverse event/effect logs – AE, SAE, ADE, SADE, USADE. We can perform sham-controlled randomized trials with our randomization module.

We are also well positioned for the move towards decentralised and hybrid trials with a number of Direct Data Capture and subject-led data capture options through the Clindox App.

Click here to learn more on our technologies for medical device trials

Concept of MDR Medical Device Regulation.

Making sense of Medical Device EDC in a complex global market

How are you achieving regulatory compliance? We all recognise that the transition to European MDR regulations are driving significant changes to compliance in the medical device industry.  Not only do new Medical Device Trials require evaluation on grounds of safety and efficacy, but existing products are also being required to demonstrate the same.
It isn’t just Europe, legislation that tightens regulatory requirements is being brought in across the globe, for example IMDR in India.
  • Understanding the regulations

    Our Medical Device Regulations page looks at the compliance situation with respect to clinical investigations

  • INFO SHEET – The MDR Regulations

    Our Info Sheet summarises the impact of the MDR regulations on the Medical Device Industry

  • Info Sheet – Pre-market regulatory requirements 

    Read more detail on pre-market regulations

  • The True Impact of MDR: a Clinical Affairs Perspective

    An experienced Clinical Affairs Director shares his insights on how MDR will impact the European market

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What our clients say

Maria Galligan, PMD Solutions

" The Clindox team have been an incredible support and are always available to help in any way they can."

Nigel McLean, Cytosystems, UK

" CRFWEB eCRF, plus their helpful and accommodating staff, helped us quickly set up and personalize, with quick turn-around times of modifications, exactly what we, the clinical staff, and statistical consultants demanded, all at an affordable price "

Next Steps

For system overview, click here

Seeing is believing. Book a consultation now.

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Useful Links

  • eCRF
  • eDIARY
  • ePRO
  • MedDRA
  • Randomization
  • Security and compliance

Latest News

June 20, 2022

Meeting the IVDR challenge: digitizing the collection of study data

Read more
March 14, 2022

Covid-19: What has been the impact of the pandemic on India and how have Indian Clinical Trials been affected?

Read more
January 18, 2022

Decentralized Clinical Trials – new kid on the block or a venerable idea resurrected?

Read more

5 Star rated on Capterra

CRFWEB is a clinical trial software application by Clindox

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