Project management of hardware and software projects in the medical device & life science industry 

• Phase-based project management (V-model, waterfall model) and agile development methods (Scrum)

• Steering of product development according to regulatory requirements from the first concept to the market launch or over the entire product life cycle 

• Time, resource & budget planning 

• Requirements management / requirements engineering 

• Specification and documentation of the development 

• Coordination of global project teams / development and manufacturing sites 

• Stakeholder management / communication with development partners, institutes, clinics 

• Patent and literature research 

• Conception and realization of user trainings for products in need of explanation 

• Supervision and monitoring of products in clinical anatomy and operating rooms

 

Technical documentation according to MDR (EU) 2017/745

• Creation, maintenance and revision of technical documentation 

• Risk management / FMEAs according to ISO14971 

• Biocompatibility assessments according to ISO 10993 

• Clinical evaluation according to MEDDEV 2.7.1 

• Design verification, design validation and design transfer 

• Preparation / review of manuals, labeling 

• Usability engineering according to IEC 62366 

 

Experience in project management / development of the following product categories:

• Anesthesia systems 
• Surgical instruments (orthopedics/neurosurgery/ENT) 
• Surgical navigation systems 
• Surgical planning software based on CT/DICOM data 
• Drug admixture tools 
• Infusion systems
• Infusion filter
• Infusion valves 
• Orthopedic implants (knee/hip) 
• Software for image-guided surgery 
• Sterile plastic disposables 
• Neuromonitoring 
• Sterile packaging

 

Interim-Management  

• Short-term and temporary support to cover staff shortages

 

 

 

 

Product approvals & registrations for different markets 

• Europe: CE conformity assessment procedures according to MDR (EU) 2017/745

• USA: Consulting on FDA 510(k) Premarket Notification 

• Consulting on approval strategy (PMA, 510(k), IDE) 

• Preparation of the necessary documents and submission to the authorities & regulatory bodies

• Communication with authorities & regulatory bodies (BfArM, FDA, Notified Body, Swissmedic...) 

  

Technical documentation according to MDR (EU) 2017/745

• Creation, maintenance and revision of technical documentation 

• Adaptation and remediation of existing documentation to new regulations 

• Risk management / FMEAs according to ISO14971 

• Biocompatibility assessments according to ISO 10993 

• Clinical evaluation according to MEDDEV 2.7.1 

• Design verification, design validation and design transfer

• Preparation of instructions for use labeling 

 

 

Clinical investigation according to ISO 14155

• Planning, realization and evaluation of clinical studies 

• Preparation and review of the necessary documentation before conducting a study 

• Training and supervision of clinical project managers 

• Design validation as part of technical documentation 

• (Non-Clinical, Pre-Clinical and Clinical Evaluation) 

• Literature search

 

 

 

 

 

 

Consulting for processes according to ISO 9001, ISO 13485, ISO 14971, ISO 14155, 21 CFR 820, MDR (EU) 2017/745), EU GMP, cGMP, MPG 

 

Support of notified body audits and FDA inspections 

 

CAPA System und Complaint Handling

 

Review and revision of SOPs and procedural instructions