Consultant in Medical Devices:

Interim Management

Regulatory Affairs

Quality Management

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.

30 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)

Quality Management

-  Installation of Quality Systems with creating of internal processes together with responsible positions. (ISO 13485)

- 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

 

If you are looking for a European Authorized Representative (EAR) service, I can recommend a partner company, which is specialized in this service.

MedNet GmbH, located in Muenster, Germany has the most professional team and provides the highest quality service in Europe for over 20 years now.

For further details, please visit www.mednet-eurep.com.