Full Service CRO

Factory CRO offers the top services for consultancy, regulatory,
and clinical trial services as well as data management and
statistics.

Learn more

Global Coverage

We are counted on for swift and reliable clinical medical
device/IVD services by companies and clients from every
corner of the globe.

Learn more

Questions?

We look forward to answering your questions and
helping you with the development of your device.

Learn more

  • 1
  • 2
  • 3

REGULATORY SERVICES

We are well acquainted with CE-marking requirements and FDA regulations and can assure that your study can be designed and controlled to meet the demands of Notified Bodies and FDA, in both the pre-market and the post-market phase of your product.

Read more

CLINICAL TRIAL SERVICES

  • Pre-study visits
  • Initiation visits
  • Monitoring visits
  • Close out visits
  • Source document verification
  • Trial document handling
Read more

CLINICAL EVALUATION SERVICES

Factory’s expert team of medical writers are well-trained in conducting clinical evaluations. We can conduct the clinical evaluation for you, or support you in the clinical evaluation process.

Read more

Latest news, blogs and events

April 6, 2017

Medical apps under the new European MDR

Worldwide 1 out of every 3 internet users currently monitors their health or fitness using an app. This was shown in a recent survey by market researcher GfK. Millions of health-related apps are downloaded every year, and this is expected...

Starter
Regulatory
Pre Market
September 6, 2017

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 21CFR830.20. Medical device labelers must submit product information to...

Starter
Regulatory
Life Cycle
November 28, 2016

Audits – a quality control tool that can’t be absent in a product development program

Nowadays, it becomes more and more important to control the various stages and (outsourced) processes in the development of a medical device. It is therefore not surprising that the revised ISO 13485:2016 is more stringent when it comes to (outsourcing) processes....

Expert
Regulatory
Post Market
25
Oct
Orlando, FL, United States

North American Spine Society (NASS)

Factory will attend the North American Spine Society (NASS) congress. The NASS is a global multidisciplinary medical society that utilizes education, research and advocacy to foster the highest quality, ethical,​ value- and evidence-based spine care for patients. This is a-kind...

Meetings & Seminars
30
Oct
700 14th St, Denver, CO 80202, USA

Transcatheter Cardiovascular Therapeutics (TCT)

TCT Meeting of the Cardiovascular Research Foundation, will be held from 29 Oct to 02 Nov 2017. The prominent event in Medical and Cardiology categories will be the centerpiece of Medical, Health Care, Cardiovascular, Vascular Medicine, Heart Care, Interventional Cardiology...

Meetings & Seminars
See all news & events

Welmoed Gjaltema

I like the dynamics, everyday is different. One day you’ll be at the office, another day you’re on site meeting new, different people.

Meet the team