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.
Abdominal Surgery
- Hand assisted laparoscopic surgery
- Continence preservation
- Electrosurgery
- Inguinal hernia repair
- Tissue glue
- Colonscopy
- Retroscopy
Cardio/Vascular Surgery
- Endovascular stenting
- Endovascular embolisation
- Endocardiovascular CPB
- Fempop
- Vascular stenting
- 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
- 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