Factory CRO for Medical Devices and IVDs

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Nederland
Bilthoven
Factory CRO for Medical Devices and IVDs

Full service European Contract Research Organization and global leader of specialization in medical device trials.

Factory-CRO is a full service European Contract Research Organization and global leader of specialization in medical device trials. Our focus lies in the complete management of clinical studies for medical devices, IVD’s, biologicals, and drug-device combinations. From determining where and how to start your clinical trial, to identifying the most influential KOL’s across Europe, our expertise will help you run the most efficient and cost-effective study possible. In addition to medical devices we have extensive experience in IVD studies, biological studies and device-drug combination, as well as therapeutic and surgical expertise, gained over the course of 20 years. On the application of the medical device, we are able to go into the field to provide in-person technical training for investigators.

17/02/2020

We are hiring!

The Factory CRO Group is currently looking for a Clinical Research Associate for the office in Bilthoven. Visit our website and LinkedIn for more information.

https://www.factory-cro.com/careers/open-positions/cra-clinical-research-associate-2/

10/01/2020

We are hiring!

Factory CRO for Medical Devices and IVDs is looking for a new Clinical Data Manager & Medical Writers to join our team.

Interested? See our website for more details.

https://www.factory-cro.com/careers/

15/04/2019

Na onze recente toevoeging van een Data Manager, heeft het sterk groeiende Data Management team weer ruimte voor een nieuwe aanwinst!

Vind hier meer informatie over de functie Data Manager bij Factory CRO in Bilthoven, NL.
https://www.factory-cro.com/careers/open-positions/data-manager-2/

Bedrijfsprofiel Na onze recente toevoeging van een Data Manager, heeft het sterk groeiende Data Management team weer ruimte voor een nieuwe aanwinst. Factory CRO is al dertig jaar actief als klinisch contract onderzoeksorganisatie die studies opzet en uitvoert voor de medische hulpmiddelen indust...

20/12/2018

We are hiring!

We are currently looking for a Data Manager (1.0 fte) for the office in Bilthoven. More information? Feel free to contact us!
For more information please see:

Bedrijfsprofiel Factory CRO is al dertig jaar actief als klinisch contract onderzoeksorganisatie die studies opzet en uitvoert voor de medische hulpmiddelen industrie. Wij organiseren patiënten studies door heel Europa, VS en Australië. Ons hoofdkantoor is gevestigd in Bilthoven waar we met een...

19/11/2018

We're hiring! Our Factory-CRO Group is seeking a highly motivated and hardworking individual interested in supporting our organizations. The candidate will develop and lead our global business development strategy together with our management team. Goals are to foster long-term relations with medical device manufacturers around the world with a focus on the USA clients. More info? https://www.factory-cro.com/careers/open-positions/business-development-director/

Send a message to learn more

06/09/2018

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.

Read our new blog at our website https://lnkd.in/gDsnW2X or on LinkedIn https://lnkd.in/gE2MXgH

01/06/2018

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

Read our colleague Jorrit Boersen his blog at our website!

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, and how do they address it? You will know more after reading this arti...

22/03/2018

What changes because of the Medical Device Regulation and how will this influence the conduct of clinical investigations with medical devices?

Read our blog on our website:

Does the MDR change your Clinical Investigations? April 5th 2017 was a historical moment for the medical device industry: the Medical Device Regulation (MDR) was adopted by the European Union. Beginning May 27th, 2020, after a 3 year transition period, this regulation will be the gold standard fo....

27/02/2018

There is interesting news in the medical device world that may impact your clinical strategy! On February 21, 2018, the FDA released its final ruling on the acceptance of data from clinical investigations for medical devices.

Read our blog at our website: https://www.factory-cro.com/news/one-medical-device-trial-fits-all-iso-14155-fda/
or on LinkedIn https://www.linkedin.com/pulse/one-medical-device-trial-fits-all-iso-14155-standard-your-leijsen/?published=t

On February 21, 2018, the FDA released its final ruling on the acceptance of data from clinical investigations for medical devices. Here, the FDA formally opens the path to submit foreign clinical data to secure marketing clearance for medical devices in the U.S. The FDA recognizes the ISO 14155:201...

13/02/2018

The reimbursement landscape is always evolving which means your reimbursement strategy needs to evolve as well. A knowledgeable reimbursement expert can assist throughout all the phases of the market adoption process. Wondering how?

Market adoption of new medical devices in the United States is largely dependent on the availability of an applicable CPT® code for use in reporting the services provided. Additionally, the existence of positive insurance medical policies outlining coverage for a particular product or service are n...

06/09/2017

The UDI Rule has been mandated by the FDA since 2013; recently, the MDR started mandating a harmonized UDI system in Europe. Wondering what these rules are about? Read more in our blog!

http://www.factory-cro.com/unique-device-identification-udi-system-path-toward-global-harmonization/

On Sept. 24, 2013, the Food & Drug Administration (FDA) mandated 78 FR 58786 (the UDI Rule), herewith establishing a unique device identification labeling system in line with the requirements of 2

31/08/2017

Niels van Tienen, Director of Education and Training at Factory, will be presenting at the Amsterdam 510k Workshop on the 11th and 12th of October, 2017. Do you want to meet us at the symposium? Please don't hesitate to contact us in advance or register at the event website!

http://www.factory-cro.com/amsterdam-510k-workshop/

http://medicaldeviceacademy.com/Amsterdam-510k-workshop/

Niels van Tienen, Director of Education and Training at Factory, will be presenting at the Amsterdam 510k Workshop on the 11th and 12th of October, 2017. Do you want to meet us at the symposium? Plea

Adres

Prof. Bronkhorstlaan 10, Bld. 54
Bilthoven
3723MB

Website

http://www.factory-cro.com/

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