medical technology

regulatory affairs in medical technology

6.1.1 Regulatory strategy development / project management for start-up
6.1.2 Risk management* by EN14971
6.1.2 Clinical Evaluation* + Clinical study design*
6.1.3 Regulatory submissions
6.1.4 TRF (Test-Report-Form) Design and Evaluation
       for detailed definition and documentation of normative requirements
6.1.5 510(k) and PMA preparation
6.1.6 CE marking, product tests and technical file
6.1.7 MDD Design Dossier* + STED Dossier*
6.1.8 FDA liaison
6.1.9 German Medical Device Directory

* all documents according to actual directives, normative standards and guidelines (e.g. MEDDEV, GHTF, ...)

research + development in medical technology

6.2.1 Projectmanagement / Creation of Design Plans
6.2.2 Packaging Design
6.2.3 Prototyping and Pilot Studies
6.2.4 Design Verification and Validation
6.2.5 Creation of Design History File
6.2.6 Process Validation
6.2.7 Sterility and Cleaning Validation

verification & validation in medical technology

VERIFICATION
6.3.1 Verification planning and controlling
6.3.2 Verification Master Plans, Verification Plans from system-level to component-level
6.3.3 Verification Test Design and Execution
6.3.4 Design of pc evaluated measurement places
6.3.5 Test Reports

VALIDATION
6.3.6 Validation planning and controlling
6.3.7 Clinical Evaluations
6.3.8 Clinical Studies
6.3.9 Usability Studies
6.3.10 Summary Reports

process development & optimizing in medical technology

6.4.1 Process development
6.4.2 Process documentation
6.4.3 Process verification
6.4.4 Process validation
       - IQ (Installation Qualification)
       - OQ (Operation Qualification)
       - PQ (Performance Qualification)

6.4.5 Process optimizing of installed processes
       - LEAN
       - LEAN / SIX-SIGMA

quality management in medical technology

QUALITY ASSURANCE
6.5.1 Development of Quality Systems (QMS) to meet FDA and ISO requirements (e.g. ISO 13485, ISO 9001)
6.5.2 Creation of SOP (standard operating procedures)
6.5.3 Development of a device master record and STED
6.5.4 Supplier qualification and auditing
6.5.5 Training
6.5.6 Quality System maintenance

QUALITY CONTROL
6.5.7 Test plan development
6.5.8 Test method creation and validation
6.5.9 Stability program development
6.5.10 Contract testing of raw materials and finished product

SPECIAL SERVICES
6.5.11 External quality management representant
6.5.12 External safety representant by german medical law §30
6.5.13 Forms for inspection & testing of medical equipments by sql
6.5.14 Develoment of databased final-check-equipment for medical & industrial products

reimbursment in medical technology

REIMBURSMENT IN THE GERMAN HEALTH CARE SYSTEM
6.6.1 DRUGS:
6.6.2 MEDICAL PRODUCT (ambulant):    EMB code
6.6.3 MEDICAL PRODUCT (stationary):   DRG code
6.6.4 MEDICAL TECHNICAL AIDS:           HMV code
6.6.5 OTHER MEDICAL PRODUCTS:        no direct imbursment
                                                      --> IGL, IVV