Our mission
- To improve the safety and effectiveness of medical devices, medical device/drug combinations, biological and cell-based products by objective testing of the conformity of product properties with predetermined safety requirements
- To guide manufacturers of medical devices, medical device/drug combinations, products towards product registration and reimbursement via the most efficient pathway
- To provide advice and facilities for preclinical and clinical research within the relevant standards and guidelines
Bielderman has experience in the preparation and execution of different medical device trial designs including 'phase II-IV' clinical trials, safety & performance studies, efficacy studies, effectiveness studies, clinical economic studies, quality of life studies, and post-marketing studies. Bielderman also has experience with different device classes like Class II (a and b) and Class III devices.
We have performed multi-centre clinical trials with 20 to 300 patients per study, recruited by 2 to 22 participating investigators in up to 10 different European countries. Follow up periods for clinical device trials vary from one month to two years, depending on the calculated safety risks of the device.
We are experienced in evaluating devices in a number of different surgery disciplines, which you can find listed below.
We have performed multi-centre clinical trials with 20 to 300 patients per study, recruited by 2 to 22 participating investigators in up to 10 different European countries. Follow up periods for clinical device trials vary from one month to two years, depending on the calculated safety risks of the device.
We are experienced in evaluating devices in a number of different surgery disciplines, which you can find listed below.
Abdominal Surgery
Hand assisted laparoscopic surgery
Continence preservation
Electrosurgery
Inguinal hernia repair
Tissue glue
Continence preservation
Electrosurgery
Inguinal hernia repair
Tissue glue
Colonscopy
Retroscopy
Cardio/Vascular Surgery
Endovascular stenting
Endovascular embolisation
Endocardiovascular CPB
Fempop
Endovascular embolisation
Endocardiovascular CPB
Fempop
Vascular stenting
laser therapy
laser therapy
Bone and Joint Surgery
Bone defect studies
Cartilage replacement
Osteosynthesis, biodegradable and non absorbable
Endoscopic spine surgery
Vertebral disc replacement
Osteoarthritis
Spine fractures
Hip Replacements
Vertebroplasty
Balloonplasty
Cartilage replacement
Osteosynthesis, biodegradable and non absorbable
Endoscopic spine surgery
Vertebral disc replacement
Osteoarthritis
Spine fractures
Hip Replacements
Vertebroplasty
Balloonplasty
Bio Cement
Urology
Nephrectomy techniques
Bladder replacement procedures
Incontinence therapies
Bladder Cancer therapies
Prostate Cancer Therapies
Grawitz tumor
Interventional Radiology
Endovascular stenting
Endovascular embolisation
Vertebroplasty
Balloonplasty
Intracranial Coiling
Wound Care
Tissue Engineered Wound Treatment
Skin Glue
Dermatology
Chronic leg ulcers