your partner in medical and
industrial business
Breaking news
Newsletter
Please enter your e-mail address to subscribe to our newsletter.
medizintechnik
|
Die medizintechnik leistet einen wichtigen beitrag zur entwicklung schneller, präziser und schonender diagnoseverfahren sowie neuer therapieverfahren mit geringeren nebenwirkungen. Sie ist aber nicht nur für das gesundheits- Der markt für medizintechnische produkte |
Aufgrund über fünfzehn-jähriger erfahrung in forschung & entwicklung, produktion sowie marketing und internationalem vertrieb von medizinprodukten bietet die plock consulting ihre erfahrungen ihren kunden in form von beratung an, führt aber auch eigene oder auftragsentwicklungs-projekte, bis hin zur zulassung und inverkehrbringung, durch. Zu diesen produktgruppen gehören produkte wie - urologie und gynäkologie, |
regulatory affairs in der medizintechnik
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