Support in realizing your visions in medical engineering
European regulations, European directives
Medical Devices Act, Medical Devices Consultant
Product liability, warranty, guarantee
ISO 10993 - Biological evaluation of medical devices
ISO 13485 - Medical devices - Quality management systems - Requirements for regulatory purposes
IEC 60601 - Medical electrical equipment
IEC 62304 - Medical device software - Software lifecycle processes
GAMP 5 - Good Automated Manufacturing Practice
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
IEC 62366 - Medical devices - Application of usability engineering to medical devices
Special needs for a special industry. Profit from our technical and clinical perspective on the development of medical devices.
You need advice and knowledge in clinical or technical niche markets? Our business is located right in the middle of the Medical Valley
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.
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.
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.
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.
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.
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.
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!
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”.
The Clinical Investigation Report (CIR)!
Read all about the R'n'B approach in our current blog post.
MDR Compliance with R'n'B Consulting
Read all about the R'n'B approach in our current blog post.
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