TRUSTED ADVISORS. EXPERIENCED PARTNERS.
Biomatech, NAMSA's European laboratory, helps medical device manufacturers verify their products are safe and perform according to their intended function. Our unique combination of preclinical and clinical expertise means we deliver the best clinical design and develop cost-effective testing programs that satisfy requirements anywhere you plan to sell your products.
YOUR PARTNER IN CLINICAL RESEARCH
Biomatech staff members have significant experience in all phases of evaluating medical devices from product design to clinical trials. We draw on an extensive body of knowledge to develop reliable and qualitative criteria that maximize the efficiency of the clinical investigation. Our staff members and associates include pharmacists, medical doctors, surgeons, biologists, data managers, clinical research associates and a range of scientists fully trained in clinical research.
Click here for Examples of clinical investigations completed for EU and FDA market approval
CLINICAL RESEARCH SUPPORT AREAS
Biomatech has extensive experience conducting clinical investigations that comply with ISO 14155 and GCP regulations.
Capabilites include:- Bibliography analysis and retrospective studies to analyze clinical data already available on devices.
- Prospective studies to assess device performance and safety, possible secondary effects and risk acceptability: trial design, study center recruitment, monitoring.
- Clinical risk analysis and management for innovative materials, new designs and new therapeutic concepts.
- Medico-economic data evaluation for device reimbursement.
- Assistance in regulatory submissions to competent authorities.
- Post market studies and analyses.
- Regulatory consulting.
|  |  | | Biomatech delivers a full package of services to ensure manufacturers have the verifications they need to submit a clinical trial application and to conduct the investigations.
- Clinical
investigation plan
- Investigator brochure
- Design of
Case Report Files
- Informed Consent
preparations
- Submission for ethical
committee approval
- Selection of
investigation sites
- Interface with
physicians and
hospitals
- Project Management
- Monitoring
- Database
development,
biostatistics, data
analysis, final report
writing
- Audits
- Result evaluation
- Statistical analysis
- Publications
EXAMPLES OF SELECTIVE
APPLICATIONS:
Implants
- Orthopedic
- Cardiovascular
- Dental
- Spinal
- Neurosurgical
- Ophthalmic
- Visceral
Tissue Healing
- Skin
- Cartilage
- Bone
- Cornea
- Vessels
Tissue Engineering |
RETRIEVED HUMAN IMPLANT
ANALYSIS AND MATERIOVIGILANCE
Our extensive expertise with histological treatment and analysis of tissue response to implanted materials makes Biomatech an effective interface between R&D issues and clinical trials. We have developed a number of technologies that provide information about the interaction between a device and the surrounding tissue and organs, such as inflammation, osteo-integrations, and degradation or endothelialization. Retrieved specimen analysis is considered an accurate source of data in evaluating the compliance or failure of a device for post marketing surveillance and quality files.
EXAMPLES OF CLINICAL INVESTIGATIONS COMPLETED FOR EU AND FDA MARKET APPROVAL
| CLINICAL INVESTIGATIONS | NUMBER
OF CENTERS | NUMBER
OF PATIENTS | | Corneal lenses | 1 | 50 | | Pulmonary suture reinforcements | 3 | 65 | | Intervertebral disk prosthesis | 4 | 50 | | Knee reconstruction | 5 | 70 | | Skin graft cicatrisation | 5 | 80 | | Coxofemoral bone graft | 8 | 80 | | Eschar healing product | 4 | 100 | | Hemodialysis shunt device | 4 | 100 | | Vascular stent | 12 | 100 | | Surgical gloves | 1 | 100 | | Alveolar ridge reconstruction device | 10 | 120 | | Bone substitute, femoral neck fracture treatment in osteoporosis | 12 | 125 | | Maxillo-facial prosthesis | 12 | 150 | | Transplant organ preservation liquid (kidney & liver) | 15 | 150 | | Intraocular lens | 8 | 310 | | Breast implants | 11 | 750 | | Gastric band in morbid obesity | 15 | 300 |
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