Switzerland
  • Switzerland
  • USA
  • confinis ag, Hauptstrasse 16, CH-3186 Düdingen, Switzerland
  • info.ch@confinis.com
  • +41 26 494 8 494
  • confinis corp., 4445 Willard Ave, Suite 600, Chevy Chase, MD 20815, USA
  • info.usa@confinis.com
  • +1 240 252 0891
confinis
confinis
  • Home
  • About
  • Services
    • Combination Products
    • In-Vitro Diagnostics
    • Product Development
    • QM, Auditing & Training
    • Regulatory Affairs
  • Blog
  • Join
    • Careers
    • Independent professional
  • Contact
    • Offices
    • Newsletter
    • Disclaimer
    • Cookie Policy
   
  • confinis partners with Irdeto to launch the first cybersecurity assessment tool in the medical devices industry
    July 6, 2021
  • confinis offers Swiss Representative Service
    June 18, 2021
  • Bei Medizinprodukten auf die EU warten hilft der Schweiz wenig
    December 3, 2020
  • Workplace glasses
    Revision der Schweizer Medizinprodukteverordnung mit Folgen
    August 14, 2020
  • Swiss Medtech Umfrage: Export in die EU mit Drittstaatanforderungen sichern
    May 1, 2020
The confinis Blog

Welcome to the confinis blog. This is the place where we are writing about news, events and helpful information. Enjoy.

Archives
Categories
  • Conferences
  • confinis
  • press release
  • Regulations
  • Workshops
Tags
#2017/745 #CHREP #FDA #machinelearning #management #newCEO 2018 artificialintelligence clinicalevaluation combination products confinis digitalhealth DKG HDE howto HUD InstA ISO13485 IVD ivdr MDCG mdr mdr article 117 MedDO medicaldevices medicalsoftware medizinprodukte Medizinprodukteverordnung MepV MRA NIS peter studer PMS post-market-clinical-follow-up post-market-surveillance presentation qms regulations samd startup swiss-medtech switzerland TOPRA ukrp workshop

Combination Products Services

  • MDR Article 117
  • Combination Products
  • Design Control
  • Risk Management
  • Usability Engineering
  • Clinical Evaluation
  • 21 CFR Part 4

In-Vitro Diagnostics

  • New IVDR
  • Classification and Regulatory Strategy
  • CE marking, FDA and global product registrations
  • Performance Evaluation
  • Software

Product Development Services

  • Digital Health
  • Design Control
  • Risk Management
  • Usability Engineering
  • Clinical Evaluation
  • Regulatory Due Diligence
  • Combination Products
  • DHF Remediation
  • Software Validation
  • Mobile Medical Apps
  • Production & Process Optimization
  • Packaging

QM, Auditing & Training Services

  • eQMS
  • Quality Management System
  • Design Control
  • Training
  • Auditing
  • Validation / Qualification
  • FDA Inspections
  • Postmarket Surveillance

Regulatory Affairs & Market Authorization

  • Digital Health
  • Regulatory Affairs Strategy
  • Market Authorization in Europe
  • Market Authorization in the USA
  • Market Authorization in other Markets
  • EC Representative
  • US Agent
RAPS - Enterprise Member Logo
© 2023 confinis ag. All rights reserved. Disclaimer & Cookie Policy. Website: SENF Digital Graphics: zwo13