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FDAnews: Postmarket Is CDRH's Top Priority, Official Says

Of all CRO's listed in the Applied Clinical Trials, Factory is the only CRO outside the US, specialized in Medical Devices

Factory is not only the best CRO but also the “fastest.” Factory CRO has won the 10 kilometer Fortis City-Pier-City business run in The Hague 3 times.

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Active in over 20 countries ›

 

Expertise

Factory-CRO is successful because we provide clients a combination of medical and technical expertise within our tightly-controlled clinical studies. Our expertise includes safety and performance studies, efficacy studies, effectiveness studies, clinical economic studies, quality of life studies, and post-marketing studies. Factory has experience with Class II (a and b) and Class III medical devices.

We have performed multi-centre clinical trials with 20 to 300 patients per study, recruited 2 to 40 participating investigators in up to 20 different European countries, and provided detailed follow-up and reporting. (Follow-up periods for clinical device trials vary from one month to two years depending on the calculated safety risks of the device.)

Start Sooner, Finish Faster

Our Experience Evaluating Medical Devices includes these Surgery Disciplines:

Abdominal Surgery                                 

  • Morbid obesity
  • Hand assisted laparoscopic surgery
  • Endoscopic surgery
  • Continence preservation
  • Electro surgery
  • Intra-abdominal adhesion prevention
  • Pancreatic stenting
  • Inguinal hernia repair
  • Tissue glue

Cardio/Vascular Surgery              

  • Endovascular stenting
  • Drug eluting stents
  • Drug eluting vascular devices
  • Endovascular embolisation
  • Tissue glue, hemostatic and surgical sealants
  • Endocardiovascular CPB
  • Cardiac adhesion prevention
  • PAD treatment

Bone and Joint Surgery             

  • Bone defect studies
  • Cartilage replacement
  • Osteosynthesis, biodegradable and non absorbable
  • Endoscopic spine surgery
  • Maxillofacial surgery
  • Vertebral disc replacement
  • Osteoarthrose

Cardio-Thorax Surgery              

  • Trans myocardial revascularisation
  • Adhesion prevention
  • Endoscopic lung resection
  • Lung air-leak sealant
  • Emphysema treatment

Urology             

  • Nefrectomy techniques
  • Bladder replacement procedures
  • Incontinence therapies

 Interventional Radiology              

  • Endovascular stenting
  • Endovascular embolisation
  • Surgical hemostatics and sealants

Wound Care

  • Tissue Engineered Wound Treatment

Dermatology

  • Wrinkle treatment
  • Chronic leg ulcers

Dental

  • Anti-bruxism therapy

Diabetes

  • Diabetes Type II treatment (smart molecule)