This page has been moved, the new location is Von der ersten Idee über die klinische Bewertung bis hin zur Marktüberwachung.

  • Starting from the first idea to the clinical evaluation and more

    Support in realizing your visions in medical engineering

  • Legal Basis

    European regulations, European directives
    Medical Devices Act, Medical Devices Consultant
    Product liability, warranty, guarantee

  • Biocompatibility, Toxicity, Microbiology, Hygiene

    ISO 10993 - Biological evaluation of medical devices

  • Quality Management

    ISO 13485 - Medical devices - Quality management systems - Requirements for regulatory purposes

  • Basic Safety, Electrical Safety of Medical Devices

    IEC 60601 - Medical electrical equipment

  • Medical Software, IT Validation, IT Security

    IEC 62304 - Medical device software - Software lifecycle processes
    GAMP 5 - Good Automated Manufacturing Practice

  • Production, Packaging, Transport, Labelling of Medical Devices

  • Clinical Evaluation, Clinical Trials of Medical Devices

    MEDDEV 2.7/1 revision 4 - Clinical Evaluation: a guide for manufacturers and notified bodies
    ISO 14155 - Clinical evaluation of medical devices for human subjects - Good clinical practice

  • Usability of Medical Devices

    IEC 62366 - Medical devices - Application of usability engineering to medical devices

  • Interdisciplinarity

    Special needs for a special industry. Profit from our technical and clinical perspective on the development of medical devices.

  • Network

    You need advice and knowledge in clinical or technical niche markets? Our business is located right in the middle of the Medical Valley

Our services for you

Individual Trainings

This way, your individual and business needs are perfectly satisifed. Save time and money by having tailor-made trainings for your staff, applicable to your devices.

Normative Context

We support you in implementing the IEC 62304 in conjunction with a quality management system according to ISO 13485. Of course we also take the processes related to risk management according to ISO 14971 and to usability according to IEC 62366 into account.

Regulatory fundamentals

Learn which legal requirements for medical software in the European Union and the USA are relevant. Of course, qualification or classification can be emphasized, as well as procedures for the assessment of conformity.

Clinical Evaluation

The last, critical phase of the development of a device is, even for medical software, the clinical evaluation. We aid you as Clinical Research Organization (CRO) in planning, implementation and publication of the necessary trials respectively in creating the literature review.

Audits and document checks

Whenever an audit is due, stress is often preprogrammed - but this shouldn't happen. Accompanying document checks are the ideal preparation for an audit. Continuous process analyses support your businesses' ambitions in improvement.

Computer validation

How reliable are your tools? We can aid you in all tasks related to computer validation. This includes software systems for ressource planning, electronic quality management systems or software embedded in your production environment.

News

  • RnB Consulting wünscht FROHE OSTERN!

  • Factsheet for IVD manufacturer

    Change of legislation
    The new regulation creates a transparent regulatory framework that enhances clinical safety and enables fair market access. IVD Factsheet

  • New CEO!

    R'n'B Consulting grows and expands! Mr. Andreas Aichinger, MSc as an additional CEO Starting with October 1, he supports us with his expertises in “Production and Cleanroom”, “Sterile Processes” and “Quality Management according to ISO 13485”. His short profile can be found under Team. We're looking forward to working together!

  • New Company Name!

    R'n'B Medical Software Consulting GmbH becomes R'n'B Consulting GmbH!
    Due to our diverse areas of expertise, the name “R'n'B Medical Software Consulting GmbH” changed to “R'n'B Consulting GmbH”.

  • New Blog Post!

    The Clinical Investigation Report (CIR)!
    Read all about the R'n'B approach in our current blog post.

  • New Blog Post!

    MDR Compliance with R'n'B Consulting
    Read all about the R'n'B approach in our current blog post.

Our References

  • Vielen Dank nochmal für heute. Das war sehr gut. Grüße Jörn Seel

    – Jörn Seel, Hectec GmbH

  • Medizinprodukt ja oder nein? Mit Ihrer Expertise war schnell Klarheit gefunden.

    – Michaela Winkler, x-tention Informationstechnologie GmbH

  • Wir haben mit der von Ihnen professionellst aufbereiteten klinischen Studie wieder eine wesentliche Hürde in der Zulassung genommen. Nochmals vielen Dank!

    – Helmut Haller, NOVOTECH Elektronik GmbH

  • Wir waren sehr zufrieden mit dem Audit, das Sie bei uns im November durchgeführt haben.

    – Barbara Weber, Hectec GmbH

  • Das Seminar zum Thema EN 62304 in Salzburg war hervorragend.

    – Siegfried Ruhri, Ginzinger electronic systems GmbH

  • Wir schätzen RnB Consulting als zuverlässigen und kompetenten Partner bei Themen rund um Qualitätsmanagement sowie gesetzes- und normenkonformer Entwicklung von Medizinprodukten.

    – Alma Sisic, HELBO Medizintechnik GmbH

Our Partners