Company profile

confinis

Industry
Medical Equipment Manufacturing
Employees
22
Headquarters
Düdingen, Switzerland/USA/UK
LinkedIn followers
5,474
Office locations
3

confinis company summary

confinis is a company in the Medical Equipment Manufacturing industry, headquartered in Düdingen, Switzerland/USA/UK. On LinkedIn the company has around 22 employees and 5,474 followers. The company lists 3 office locations. Its listed specialties include Medical Devices, ISO 13485, 21 CFR Part 4, 21 CFR Part 820, Design Control.

What technology does confinis use?

No technologies detected yet. Warmrank rechecks company websites on a rolling basis.

About confinis

confinis ag, now part of athagoras Group, 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).

Specialties

Medical DevicesISO 1348521 CFR Part 421 CFR Part 820Design ControlIEC 62304IEC 60601-1IEC 62366-1MDD 93/42/EECDrug DeliverySOR/98-282ISO 14971IVDDCombination Products21 CFR Part 11Regulatory AffairsQuality ManagementMDR 2017/745IVDR 2017/746MDSAPCH-REP

Where is confinis located?

confinis lists 3 office locations.

Düdingen, Switzerland/USA/UK, CHHQ
Hauptstrasse 16
Cambridge, CB4 0WS, GB
St John’s Innovation Centre
Durham, NC`, US
600 Park Offices Drive

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Frequently asked questions about confinis

What does confinis do?

confinis ag, now part of athagoras Group, 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).

How many employees does confinis have?

confinis has around 22 employees on LinkedIn.

Where is confinis headquartered?

confinis is headquartered in Düdingen, Switzerland/USA/UK.

Where does confinis have offices?

confinis lists 3 office locations, including Düdingen, Switzerland/USA/UK, CH; Cambridge, CB4 0WS, GB; Durham, NC`, US.

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