confinis
Düdingen, Switzerland · Health and Medical
This profile has not been verified by the business owner.
Information may be incomplete or outdated.
#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
Overview
confinis is a Switzerland-based regulatory consultancy specializing in medical device compliance, offering expert guidance to manufacturers navigating the complexities of the European Union Medical Device Regulation (EU MDR) and In Vitro Diagnostic Regulation (IVDR).
We support companies throughout the entire product lifecycle, from initial concept and design to market authorization and post-market surveillance. Our team of experienced regulatory professionals provides comprehensive services including clinical evaluation, technical documentation, quality management system (QMS) implementation, and post-market surveillance support.
confinis assists clients in achieving compliance with regulations such as 21 CFR Part 820, 21 CFR Part 4, ISO 13485, MDSAP, and the new EU AI Act. We are committed to helping our clients successfully launch and maintain their medical devices and IVDs in the European market, ensuring patient safety and regulatory adherence. We also offer Swiss Representative (CH REP) and UK Responsible Person (UK RP) services.
We have supported the registration of over 2,000 medical devices and 200 combination products, demonstrating our deep expertise and track record of success.
We support companies throughout the entire product lifecycle, from initial concept and design to market authorization and post-market surveillance. Our team of experienced regulatory professionals provides comprehensive services including clinical evaluation, technical documentation, quality management system (QMS) implementation, and post-market surveillance support.
confinis assists clients in achieving compliance with regulations such as 21 CFR Part 820, 21 CFR Part 4, ISO 13485, MDSAP, and the new EU AI Act. We are committed to helping our clients successfully launch and maintain their medical devices and IVDs in the European market, ensuring patient safety and regulatory adherence. We also offer Swiss Representative (CH REP) and UK Responsible Person (UK RP) services.
We have supported the registration of over 2,000 medical devices and 200 combination products, demonstrating our deep expertise and track record of success.
Contact Details
ukrp@confinis.com
Düdingen, Switzerland, Hauptstrasse 16
+2
Company Type
Private Limited Company
Employees
20-30
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
Companies teams usually look at after confinis
Comparing a few options usually leads to better decisions
Save companies to compare later. Useful when sharing options with your team
This is how your company profile looks to others.