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Our core competencies lie in the consulting, planning and implementation of regulatory affairs projects in compliance with stakeholder requirements and required regulations.

We also offer developement services for manufacterers, including service, maintenance and repair work
for users.

CUSTOMERS & RECOMMENDATIONS

REGULATORY AFFAIRS MANAGEMENT

CREATION OF AN
MDR | IVDR ROADMAP

GAP Analysis

Formulate Intended use & performance promises

Classify products

Implement QM system, UDI system

IMPLEMENTATION OF LEGAL REQUIREMENTS

Creation of the product file
according to MDR, national and regional regulations

Classify products according to MDR classification rules

Selecting the conformity assessment procedure

Implement clinical evaluation requirements according to MEDDEV 2.7/1 Revision 4

Implement post-market surveillance PMS

IMPLEMENTATION OF GSPR

Proof of the general safety and performance requirements through harmonised standards and state of the art

ISO 13485 Medical devices – Quality management system

ISO 14971 Application of risk management

IEC 62304 Software life-cycle processes

IEC 62366-1 Application of usability engineering

IEC 60601-1
Medical electrical equipment – General requirements for basic safety and essential performance

CONTACT

MEDICAL ENGINEERING

ELECTRICS | PNEUMATICS

Creation of normative documents

  • Functional diagrams
  • Block diagrams
  • Insulation diagrams
  • Wiring, pneumatic and hydraulic diagrams

MECHANICS

Creation of CAD construction drawings

  • Prototype drawings
  • Production drawings
  • Assembly drawings

SOFTWARE

Designing and documenting the software

  • Selection of a development process
  • Drawing up specifications
  • Testing the usability
  • Implementation in the technical documentation

SAFETY INSPECTION

According to the MDR and national regulations, dental and medical devices must be inspected recurrently, between 12 and 36 months.

The frequency of the inspection depends on the type of device and the manufacturer’s specifications.

MAINTENANCE & REPAIR

The devices are maintained and checked on site, taking into account your daily procedures.

We will support you by suggesting solutions to rectify any defects found.

All repairs are carried out promptly and in compliance with all normative requirements.

INSPECTION ACCORDING TO

IEC 62353
Medical electrical equipment

MDR
Medical Device Regulation

National regulations

CONTACT

CUSTOMERS

Our customers are manufacturers of dental and medical devices, physiotherapy centers and dental clinics in Austria and Germany.

RECOMENDATIONS

Advising the company Innodent on the realisation of the TM6+ dental treatment unit.

  • Creation of an MDR roadmap
  • Implementation of legal requirements
  • Proof of GSPR
  • Creation of normative required documents

Advising the company Innodent on the realisation of the dental suction unit PowerSuc.

  • Creation of an MDR roadmap
  • Implementation of legal requirements
  • Proof of GSPR
  • Creation of normative required documents
CONTACT

Our goal is not only comprehensive advice and support, but also optimal pricing.

CONTACT

You can reach us by phone

  • Mo – Thu 
    08:00 – 17:00
    Fr
    08:00 – 13:00

Write us!


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