Starting from the first idea to the clinical evaluation and more

Starting from the first idea to the clinical evaluation and more

Support in realizing your visions in medical engineering
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

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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 und 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

01.08.2016
New Employee!

R'n'B Consulting grows and expands! Starting with August 1, Melanie Baumgartner supports us with her expertise in “Usability” and “ISO 80001”. Her short profile can be found under Team. We're looking forward to working together!
11.05.2016
New DokuWiki Plugin published!

Calendaring functionality in DokuWiki Link to Documentation

Get an overview on our services related to configuring electronic quality management systems based on the proven DokuWiki Syntax! Link

Timeline of @RnB_Consulting
	#thetimeisnow #WeCan #MDR #MedicalDevices https://t.co/R40ZWZQizQ https://t.co/juqrjDj2dS About 1 month ago by: RnB-Consulting (@RnB_Consulting)
	#MDR #MedicalDevices #howto https://t.co/f2A0yDaFy6 https://t.co/UTuZX0wPke About 1 month ago by: RnB-Consulting (@RnB_Consulting)
	#newevent #medicaldevice #newregulation Veranstaltungstipp: MedTech.Factory: Medical Device Regulation - und jetzt… https://t.co/aKXXFeL4JT About 1 month, 2 weeks ago by: RnB-Consulting (@RnB_Consulting)
	#event #Tips #medicaldevice https://t.co/mx0kYseVZY https://t.co/EgLVfPPpb5 About 3 months, 1 week ago by: RnB-Consulting (@RnB_Consulting)
	#we #are #hiring #NewJob #newlife #medicaldevice #ProjectManagement #regulatory https://t.co/ZJQCx3E0k5 About 4 months ago by: RnB-Consulting (@RnB_Consulting)

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

Starting from the first idea to the clinical evaluation and more

Interdisciplinarity

Network