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medical technology


Medical technology contributes effectivly to
the development of fast, precise and gentle
diagnostic analyses and also new forms of
therapy with less side effects.

It is not only important to the health system
but also for industrial development.

The market for medical technology devices
and systems, as well as the new market for combination products belongs to the most
attractive growth markets with high rates
of increase around the world.

Based on over fifteen years experience in research & development, production as well as marketing & international sales, plock consulting offers this know how to different kind of customers, especially in medical products like
- urology and gynaecology,
- insulin delivery devices,
- medical audio devices,
- surgical implants,
- dental products,
- sterile single use products,
- cleaning- & desinfection devices
- combined products
  (medical product + pharmaceutical product).

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

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

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

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

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

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

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