Profile

MR Beat Steffen

Contact Details

RegEx Pro

Bio

confinis is a consultancy specializing in providing advice and services for medical device and combination product manufacturers. confinis' core competences are in business practices - quality management and regulatory affairs services (QSR, MDD 93/42/EEC, SOR/98-282 (CMDR), ISO 13485, 21 CFR Part 4), life-cycle management, software development life-cycles (e.g. IEC 62304), product risk management (ISO 14971), usability engineering (IEC 62366 / IEC 60601-1-6)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.

Education

Private Hochschule Wirtschaft, Zurich
Executive MBA
2004 To 2005

University of Applied Sciences, Bern
MSc
1991 To 1994

Year Entered Profession

  • 1990-1994

Current Organization Type

  • Consulting Firm

Job History

Lead Auditor (ISO 13485, Directive 93/42/EEC, SOR/98-282)
Zollikofen
July 2005 - present

Founder, CEO
Dudingen
July 2005 - present

Head of Project & Risk Management
Burgdorf
March 2002 - June 2005

Senior Project Manager
January 1999 - February 2002

Highest Degree Earned

  • Masters

Regional Interests

  • Asean
  • Brazil
  • Canada
  • China
  • Europe
  • Japan
  • Latin America/Carribean
  • Other Asia
  • US

Product Interests

  • Biologics/Biotechnology
  • Biosimilars/Generic
  • Combination Products
  • IVDs
  • Medical Devices