Consultant in Medical Devices:
For your company you can use my knowledge, skills and experience over long years in Quality Management, Regulatory Affairs and Interim Management with a view to Medical Devices. With a look to smaller companies without enough capacity in this area I can offer support for these leakages. But in the same way I can feel gaps in bigger companies too.
25 years experiences in Medical Devices, including 20 years working in Management position in a middle size company, but linked to a world wide activity company, you can participate at the skills.
With pleasure I can offer an individual package. Give me a call or send an email with your interest.
Skills in English and German languages, MS offices products
Experience in externals plants in Europe – especially in East Europe.
Detailed Services in Medical devices
Interims Management and consulting in Medical Devices
- Take over of Regulatory Affairs and/or Quality responsibility (interim)
- Take over of responsibility at product area (e.g. Persons charged with supervisory functions for MD
- Support or escorting during external audits
- Assessment of internal and external audits
- Regulatory affairs issues for medical devices (CE-mark, standards...)
- Installation or outplacement of production floors, outplacement of processes like assembling, packaging, sterilization
- CE-Mark for Medical Devices (technical files for all product classes including design dossiers for class III)
- Risk Management according ISO 14971
- Moderation of Risk Analysis
- Creating a Risk File: Risk management plan, Risk analysis, Risk Assessment and Risk Control
- Follow up of post market data’s, follow up of corrective actions for the entire life cycle of a Device.
- Installation of Quality Systems with creating of internal processes together with responsible positions. (ISO 13485/9001/14971)
- Optimizing of existing Quality Systems; 13485 for medical devices
- Support in Management Review
- Training of staff (from single departments or the hole company) in all medical devices issues
- Supporting and/or taking of external and internal audits
- Technical assessment of external companies (e.g. supplier, due diligent for candidates in medical devices areas.
- Technical assessment of products or/and companies
- Transfer of parts or the hole production to another location
Product Certification for Medical Devices
- Project Management in technical product development (starting with the idea coming form the client or customer until registration and going to the market)
- Support in creating or optimizing of technical files (e.g. essential requirements, risk management for MD)
- Classification of products
- Registration of products in EU or other countries
- Labelling according the valid guidelines
- Support in looking for new suppliers (e.g. for sterilization, packaging and qualification of suppliers
- Training of sales Reps in regulatory field
- Training of Persons charged with supervisory functions for MD (in Germany: Sicherheitsbeauftragter für Medizinprodukte)
- Build up of quality control
I can offer training for your stuff for
- CE marking
- Technical documentation, content Review
- Risk management
All training is in-house seminars or trainings and will fit to your individual need.
I can moderate workshops which allow you and your stuff to work directly in the problem areas.
In the same way I can support you during the daily work. E.g. review of created documents for registration.