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Clinical trials in compliance with EN540 regulations and
ISO 14155 standards are performed to assess device
performance, possible secondary effects and risk acceptability.
These studies are required for implantables and Class III and
some Class 2b devices. Studies may be conducted according
to Good Clinical Practices (GCP) and Internal Conference of
Harmonization (ICH).
Capabilities 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.
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Biomatech helps medical device manufacturers with clinical trials that 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.
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