Post-market Medical Device Studies

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

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 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
Medical coding (MedDRA) and Randomization

Making sense of Medical Device EDC in a complex global market

How are you achieving regulatory compliance? for example, we all understand the transition to European MDR regulations are driving significant changes to compliance in the medical device industry. Legislation that tightens regulatory requirements is being brought in across the globe, for example IMDR in India. 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.

The clock is ticking as you figure out the optimal path to maintain compliance. CRFWEB can be part of your strategy. It is a proven medical device study software application and can help facilitate a rapid turnaround of design and data entry for your medical device clinical study or program – whilst providing all the reporting outputs you need. CRFWEB will also provide a full electronic audit trail and a host of additional features to make your clinical study efficient, manageable and reportable – even when your study is performed across multiple sites in a number of countries.

Can you risk your regulatory body turning down your licence application or disrupting product sales?

Clearly the answer is no, so act today and get in touch with CRFWeb to discuss the ways we can help you.

Concept of MDR Medical Device Regulation.

Learning more on post-market regulatory impact

It’s important to have a thorough understanding of the post-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 – Post-market StudiesA guide to the requirements of Post-Market Clinical Follow-up studies as part of Post-Market Surveillance 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 EDC database like CRFWEB, with the requirements of Medical Device studies in mind, will make your study manageable and reportable. Deploy CRFWEB for these study types:

Pilot or Feasibility
First-in-Human
Pivotal
Post-Market Clinical Follow-up
Post-Market Safety Study
Registry
Investigator Initiated Study

CRFWEB is a fast to set-up fully functioning, flexible, reliable and cost-effective SaaS EDC platform to manage medical device clinical studies. Its a critical part of your strategy to get your products to market. And a critical element to keep your products compliant post-market.

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 CRFWEB app including eConsent, eDiary and ePRO.

5 Star Reviewed

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

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Latest News

June 20, 2022

Meeting the IVDR challenge: digitizing the collection of study data

March 14, 2022

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

January 18, 2022