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Inside Medical Technology

11 - 12 April 2018 // Nuremberg, Germany

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Exhibitors & Products MT-CONNECT 2018

AstraCon GmbH

Hauffstraße 15

72074 Tübingen

Baden-Württemberg

Germany

Phone: +49(0)176.23381476

Fax: +49(0)8856.8051858

Halle

Other exhibitors (26)

Products of AstraCon GmbH (5)

Regulatory Affairs

LOGO_Regulatory Affairs

Quality Management

LOGO_Quality Management

Technical Documentation

LOGO_Technical Documentation

Risk Management

LOGO_Risk Management

IVD

LOGO_IVD

Our Philosophy
Regulations are often perceived as a burden and an obstacle on the way to CE and market access. We show you how to integrate regulation into your daily operations. We are convinced that every failure in the quality management system of a company can translate into death of a patient. Patient safety and risk based approaches are the basis of our daily work.


The new Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) have huge impact on the industry. We offer you strategic consulting to take important decisions, such as:

  1. Which milestones do you have to reach until when to change to the new MDR?
  2. How do you prepare your Technical Documentation to comply with the new MDR?
  3. How can you allocate your resources best? Do you need interim support on specific topics?
  4. What changes do you have to implement if you are a Private Label Manufacturer?


We also help you with the communication with authorities, Notified Bodies, Competent Authorities
and Expert Panels.


Specifically, for MedTech Start-Up Companies we offer following services:

  • establish a regulatory department
  • state-of-the-art Quality Management System (QMS) according to ISO 13485
  • Standard Operation Procedures (SOPs)
  • roadmap to the CE mark for the first medical device
  • selection of the Notified Body that best fits your requirements
  • for small companies: Responsible for Regulatory Compliance (MDR)
     

For established enterprises we offer:

  • support with Post Marketing Surveillance activities, such as complaint handling, customer feedback, CAPA handling, FDA medical device reporting and determination, EU vigilance
  • maintenance of Technical Documentations
  • continuous risk management
  • roadmaps for new CE certificates
     

For Private Label Manufacturer and Original Equipment Manufacturer:

  • Technical Documentation for OEM and PLM
  • check / development of Quality Agreements between OEM and PLM
     

Other services we offer:

  • classification statements for borderline products
  • internal audits (1st party audit) and supplier audits (2nd party audits)
  • support with external audits (3rd party audit)
  • risk management
  • biocompatibility
  • state-of the-art clinical evaluation
     

Product Development

  • due diligence for product acquisitions
  • regulatory input for new product development
  • early risk analysis
  • communication with authorities and investors
     

Resource Management

  • specialists for regulatory projects to relieve your team during work peaks
  • interim management, interim team lead
  • interim replacement for maternity and parental leaves
  • search for experts worldwide
  • training of your team on QM and regulatory topics

AstraCon GmbH offers you products from these product groups:

Sector

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