Switzerland
  • Switzerland
  • USA
  • confinis ag, Hauptstrasse 16, CH-3186 Düdingen, Switzerland
  • info.ch@confinis.com
  • +41 26 494 8 494
  • confinis corporation, 15807 Glacier Ct, North Potomac, MD 20878, USA
  • info.usa@confinis.com
  • +1 240 252 0891
confinis
  • Home
  • About
  • Services
    • Combination Products
    • Product Development
    • QM, Auditing & Training
    • Regulatory Affairs
  • Blog
  • Join
    • Careers
    • Independent professional
  • Contact
    • Offices
    • Newsletter
    • Social Media
    • Disclaimer
    • Cookie Policy
confinis
  • Home
  • About
  • Services
    • Combination Products
    • Product Development
    • QM, Auditing & Training
    • Regulatory Affairs
  • Blog
  • Join
    • Careers
    • Independent professional
  • Contact
    • Offices
    • Newsletter
    • Social Media
    • Disclaimer
    • Cookie Policy
Call us at +41 26 494 8 494 (CH) or +1 240 252 0891 (USA)
Mail us at info.ch@confinis.com (CH)
or info.usa@confinis.com (USA)
Find us at Hauptstrasse 16 3186 Düdingen, Switzerland 15807 Glacier Ct North Potomac, MD 20878, USA
  • Classification of medical devices under the European Medical Device Regulation 2017/745
    November 12, 2018
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
  • Regulations
Tags
#2017/745 #FDA 2018 combination products conference confinis ISO ISO13485 ivdr mdr mdr article 117 medicaldevices motivation PMS presentation regulations report switzerland TOPRA usa workshop

Combination Products Services

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

Product Development Services

  • 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

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

Regulatory Affairs & Market Authorization

  • 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
© 2018 confinis ag. All rights reserved. Disclaimer & Cookie Policy. Website: SENF Digital Graphics: zwo13