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Risk Based Monitoring – A state of the art approach for your clinical investigation

Factory CRO witnesses and is part of a new trend in the clinical investigation landscape: Risk Based Monitoring (RBM). In this novel approach, focus lies on specific risks related to your clinical investigation, thereby more efficiently using resources, which improves investigation conduct and quality. Under the guidance and regulation of ISO 14155, MDR, TGA and the FDA, the rights and safety of subjects are ensured while maintaining the integrity of data. However, the extent and nature of the monitor activities can be determined by the sponsor. The FDA’s guidance for...

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Meetings and seminars

Monday, Dec 17, 2018

Factory CRO for Medical Devices B.V., Professor Bronkhorstlaan, Bilthoven, Nederland

Essentials on Lifecycle Management under the EU MDR

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Latest news

Five Corners joins Factory CRO

Bilthoven, Netherlands — Factory CRO, a leading global contract research organization (CRO) focused on medical devices and in vitro diagnostics (IVDs), has announced that Five Corners is joining Factory CRO. Five Corners is the premier device CRO in Australia, supporting the...

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Post-market surveillance under a “522 order”: Why, how and what?

Company X has gained 510k clearance for their new heart valve, and was notified by the Food and Drug Administration (FDA) that post-market surveillance (PMS) is required. Why did they receive it, what is it and what does it mean,...

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FREE 30 minutes consultation

You may have questions about the regulatory framework for medical devices or clinical trial requirements or even Factory CRO’s services.