INTERNATIONAL EXPERTS

The AUREPS experts team is your competent partner for the approval of medical devices. Our clients are manufacturers, importers and distributors of medical products and devices. 

The international legal requirements and laws are complex and subject to constant change. European medical directives and their interpretations must be implemented at all levels. 

AURPES offers a software based comprehensive service so that you can meet your regulatory responsibilities at any time when placing your products on the market.

Olaf Schäfer
MANAGING PARTNER

Product Development
 
More than 25 years of experience in medical device development including active devices, prosthetic implants, cardio vascular endoprostheses, design control procedures, risk management & usability engineering. More than 20 generic patents. 
 
Quality Management
 
Certified lead auditor MDD 93/42
Certified lead auditor MDR 2017/745
Author of several QM-Systems in proven compliance to EN ISO 13485
 
Regulatory Affairs
 
CE certification and conformity assessment procedures for class I, Is, Ir, Im, IIa, IIb, III devices
FDA 510(k) submissions
NMPA (China) submissions
TGA (Australia) submissions 
 
Specialized industry expertise:
  • Medical / Healthcare
  • Consumer goods
  • Industrial / Manufacturing

Stefan Hartl
MANAGING PARTNER

RA Stategies
Strategy & Planning
Brand & Sales
Coaching & Advisory
Negotiation & Mediation
Evaluation & Monitoring
Online Marketing

Specialized industry expertise:
  • Medical / Healthcare
  • Media
  • Consumer goods

Manuel Neuer
ASSOCIATE PARTNER

Global Regulatory Affairs Strategies 
Regulatory Affairs Advisory 
Asia Regulatory Affairs Consultancy 
Analysis & Assessment
Strategy & Planning
Marketing & Communication
Sales Network Development 
 
Specialized industry expertise:
  • Medical
  • Healthcare

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