Relevant Expertise/Experience
• Design, manufacture and marketing of medical devices including artificial joint
• Compliance with the regulatory requirements
• Commercialisation of medical devices
• Exploitation through commercialisation
• Design, manufacture and marketing of medical devices including artificial joint
• Compliance with the regulatory requirements
• Commercialisation of medical devices
• Exploitation through commercialisation
Role in the project
• Provision of test specimens for pre-clinical testing of coating
• Advice on the regulatory and exploitation plan
• Testing of the prototype prostheses
• Exploitation through (a) standards and (b) device commercialisation
Peter Brehm Chirurgie-Mechanik e.K. (PB) was founded in 1981 and specialises in orthopaedic implants. The product range covers both endo-prostheses of the hip, knee, and spine and surgical instruments, with the focus on the highly bio-compatible implant material titanium and its alloys. PB is the German market leader in modular revision systems for the hip, and its products MRP-Titan and MRS-Titan are used in almost all of Germany’s university hospitals and specialised orthopaedic centres. PB follows the latest international quality standards EN ISO 9001 and EN ISO 13485 and is certified and continuously regulated by MedCert (MedCert Zertifizierungs- und Prüfungsgesellschaft für die Medizin GmbH). All orthopaedic products have earned the CE label and are sold in all relevant international markets except the USA.
Among PB’s facilities are construction and manufacturing, testing and packaging, roughness determination, cleanroom facilities, laboratories for quality assurance and biomechanical testing, and a regulatory affairs department.
Partner contribution
PB provides test specimens for pre-clinical testing of coating, advice on the regulatory and exploitation plan, testing of the prototype prostheses, and contributes to exploitation through standards and device commercialisation.
