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Very few technical fields are subject to as many regulations as the production of medicines and pharmaceutical substances. There could be more regulations for Good Manufacturing Practices (GMP) than guidelines for their implementation.

The development of medical products requires the transparent and consistent documentation of each individual step from the very start. Therefore, GMP-compliant production and validation as well as development and optimisation of processes play a prominent role if scientific engineering principles and rules are used in pharmaceutical and biological technology.

Thus, our developers focus in particular on

  • the definition of a consistent systematics, a project architecture and a software lifecycle,
  • the creation of performance and functional specifications in accordance with approval requirements
  • and the use of digital versioning and documentation software (SVN).

This is how we ensure that our customers

  • remain flexible thanks to scalable project organisation,
  • experience the greatest possible transparency within the project,
  • can separate information into that which is approval-specific and device-specific,
  • receive standardised documents directly during product development,
  • can track or restore any project status at any time.

Get ahead!
Thanks to interdisciplinary co-operation during complex product developments and the implementation of your requirements in innovative product solutions.

Project example (production machinery)

Production of coagulation-promoting wound dressings according to GMP regulations
In co-operation with KETTENBACH MEDICAL and Hematris Wound Care, provenion gmbh developed an automated procedure to manufacture the Hematrix® active patches for external wound healing.

Project examples (test and analysis systems)

Detection of pathogen contamination in drinking water and food

provenion is development partner of a European consortium working on the development of an on-site DNA analyser.

 

Project example (product and device development)

Endovascular brachytherapie thanks to itm Rhenium-PTA©
provenion gmbh and itm FlowMedix GmbH co-operated to develop a device for percutaneous transluminal coronary angioplasty using radioactive fluid.

Project example (product and device development / control technology and software)

DNA analysis in desktop format

provenion gmbh and directif gmbh co-operate to develop a device for DNA /RNA analysis.

Project example (bio-technology / medical engineering)

Design and prototyping of a device for endodontic treatment