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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).
Kythera Labs provides a data management and analytics platform to process healthcare data of all types and apply machine learning to look for signals that can report and predict behavioral patterns of patients, practitioners, health systems, and payers. We help healthcare information companies build enterprise-scale products to serve their customers, and we help all types of healthcare organizations (e.g. hospitals, pharmaceutical manufacturers, technology companies, government entities) understand the performance of their markets and the individual entities within them. Our sample of over 300 million US patient-lives, served from our cloud-based, machine learning-driven platform, brings scale and speed that performs exponentially faster than any other technology in the healthcare data and analytics world. Bring your own data to our platform and we will combine it with ours to give you an unsurpassed view of healthcare events at a level of fidelity and quality that is quickly actionable and highly affordable. The team at Kythera Labs has been solving problems for decades using proven data science concepts and unique technologies to enable decision making and growth for healthcare organizations. Our focus has been to be humble and curious in all of our work. We have learned life is too short to not enjoy the journey. Our team understands that trust is at the heart of innovation and it is something we work at everyday.
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