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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).
Shapiro/Kleinberger Investment is a New York, NY-based company in the Business Services sector.
Lustig International is a San Leandro, CA-based company in the Business Services sector.
SAASTEPS is a one-app Revenue Acceleration Management suite built 100% Native & Lightning on the Salesforce platform. We offer a suite of standardized, scalable, and affordable solutions that allow your business to increase efficiency and maximize revenue. Standardized, Modular Features - No more costly, time-consuming customizations. All of our solutions are standard, so you can use what you need right now, and easily add on more as your business grows (and save a ton on operational costs). Everything in One Place - We believe that simplicity is key to efficiency; thats why we created the SAASRAM™ suite. Manage your accounting & finance, sales, customer success & retention, marketing and admin needs all in one seamless solution. Easy Implementation - Most solutions can take months to implement. Because our technology requires no custom coding, self-implementation is quick and easy. Prefer help? Our team or implementation partners are here for you. Get up and running in as little as 2 weeks (seriously!) and spend your time on the things that matter. Shop Small - Get the innovation of a large corporation with the heart of a small business. Our technologies are built on the foundation of decades of industry knowledge from our leadership team. Weve removed unnecessary complexities (and costs) so that we can focus on our true passion - helping our customers succeed; this is the SAASTEPS way.
Phillips, DiPisa and Associates is a Hingham, MA-based company in the Business Services sector.