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Alfred Lerch Email
Chief Financial Officer . confinis
Sursee,
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Employees:
37Revenue:
$9.3MAbout
confinis is a regulatory consultancy specializing in providing advice and services to the medical device, combination product and IVDD manufacturers. confinis' core competences are in business practices - quality management and regulatory affairs services (21 CFR Part 820, 21 CFR Part 4, MDD 93/42/EEC, MDR 2017/745, IVDR 2017/746, CMDR, ISO 13485, MDSAP), design control, clinical evaluation (MEDDEV 2.7/1 rev. 4 and MDR), software development life-cycles (e.g. IEC 62304), product risk management (ISO 14971), human factors (IEC 62366-1), electrical safety (IEC 60601-x), validation (computer system validation, process validation, GAMP 5, 21 CFR Part 11 etc.), remediation activities, auditing, training and project management, with particular expertise in new product development from idea through registration to commercialization and post-market activities. confinis was instrumental in obtaining market authorization for way more than 1'000 medical devices and 100 combination products.confinis Address
Hauptstrasse 16Sursee, null