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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, MDR 2017/745, IVDR 2017/746, CMDR, ISO 13485, MDSAP), design control, clinical evaluation, 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 2000 medical devices and 200 combination products. We also provide the service as a Swiss Authorized Representative (CH REP) and a UK Responsible Person (UK RP).
Veselka is a New York, NY-based company in the Business Services sector.
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Murray Information Systems is a Meridian, NY-based company in the Business Services sector.
Elliott Beach Rentals is a division of Elliott Realty that has served the Myrtle Beach community and the beachs visitors since 1959. We have been providing picture perfect vacations in Myrtle Beach for families, couples and golfers. We believe our excellent service and affordable prices are unmatched by anyone along the Grand Strand.