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Pre-licence investigations for Medical Devices
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.
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.
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.
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.
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.
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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