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confinis logo — confinis means: the missing particle. We want to fill the mi...

confinis

confinis means: the missing particle. We want to fill the missing particle in your business and attain success together.

Founded 2005 Switzerland Dudingen, Switzerland 32 employees Health Care, Medical Devices +1

General Information

Company Name confinis
Founded Year 2005
Location Switzerland Dudingen, Switzerland +3
Founders / Decision Makers
Team member
Employees 32
Industries Health Care, Medical Devices, Pharmaceutical
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About confinis

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 2'000 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).

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FAQ About confinis

confinis means: the missing particle. We want to fill the missing particle in your business and attain success together.
confinis was founded in 2005.
confinis is headquartered in Dudingen, Switzerland.
confinis operates in the following industries: Health Care, Medical Devices, Pharmaceutical.
confinis has approximately 32 employees.
Top alternatives and competitors to confinis include Accumedix, Inc., incuMeD, MD Precision Inc., MethodSense, Inc., Garrett Technologies, Inc.. These companies operate in related industries and serve comparable markets. You can compare them side by side on Bounce Watch.
confinis and Accumedix, Inc. are both companies in similar industries. Compare their funding, team size, growth signals, and market position on Bounce Watch to see which one fits your needs.

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