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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).
Allen Communication Learning Services is a Salt Lake City, UT-based company in the Business Services sector.
Support Financial Resources is a Dayton, OH-based company in the Business Services sector.
ofarrell design inc is a Seattle, WA-based company in the Business Services sector.
ShockWatch is now part of SpotSee! SpotSee is an internet of things end-to-end solution provider that enables customers to spot damage in their operations and see it in real time. SpotSee has developed a low-cost, connected, ecosystem that delivers data from devices anywhere in the world to customers` fingertips. SpotSee devices monitor shock, vibration, temperature and other environmental conditions through its market-leading brands such as ShockWatch, ShockLog, OpsWatch, SpotBot, and WarmMark. The company has a global network of over 300 sales and technical service partners in 62 countries. SpotSee is headquartered in Dallas, Texas, with operations in the Netherlands, United Kingdom, Shanghai, Mexico City, Chihuahua and Graham, Texas.