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).
Company Details
- Employees
- 24
- Founded
- -
- Address
- Hauptstrasse 16, Düdingen,switzerland/usa/uk 3186,switzerland
- Phone
- 41 264948494
- in****@****nis.com
- Industry
- Medical Equipment Manufacturing
- NAICS
-
Medical Equipment and Supplies ManufacturingSurgical and Medical Instrument ManufacturingSurgical Appliance and Supplies ManufacturingDental Equipment and Supplies ManufacturingOphthalmic Goods ManufacturingDental Laboratories
- Website
- confinis.ch
- Keywords
- Medical Devices, ISO 13485, 21 CFR Part 4, 21 CFR Part 820, Design Control, IEC 62304, IEC 60601-1, IEC 62366-1, MDD 93/42/EEC, Drug Delivery, SOR/98-282, ISO 14971, IVDD, Combination Products, 21 CFR Part 11, Regulatory Affairs, Quality Management, MDR 2017/745, IVDR 2017/746, MDSAP, CH-REP.
- HQ
- Düdingen, Switzerland/USA/UK
Confinis Questions
Confinis's helpline number is 41 264948494
Confinis's website is confinis.ch
Confinis's LinkedIn profile is https://www.linkedin.com/company/confinis
Confinis has
24 employees.
View email and phone details for 24
employees at Confinis.
Confinis's industry is
Medical Equipment Manufacturing
Confinis's top competitors are
Mhetra,
Congenius Ag,
Bonebridge,
Swiss Medtech,
Effectum Medical Ag,
Md-Clinicals,
Ypsomed Ag,
Axxos Ag,
Qumea,
Iss Ag, Integrated Scientific Services.
Confinis's support email address is info.ch@confinis.com
Confinis's categories are Medical Equipment Manufacturing
Confinis's founding year is 2005
