CONSULTING FOR MANUFACTURERS AND DISTRIBUTORS OF MEDICAL DEVICES, IN VITRO DIAGNOSTICS AND LABORATORY EQUIPMENT

CONSULTING IN TIMES OF CHANGE

The consulting services of CONSILIO ET OPERA GMBH cover the same departments already mentioned under the menu “PROJECT AND INTERIM MANAGEMENT”: quality management, regulatory affairs, sales and marketing as well as strategic business unit management.

In contrast to a fully operated corporate function within an interim management mandate, our services focus on strategy development as well as organizational and process consulting. After profound analysis of our customers’ challenges and consideration of the changing environment, we provide decision-making aids for their mastering. The resulting packages of measures are finally implemented by our customers.

STRATEGY DEVELOPMENT, ORGANISATIONAL AND PROCESS CONSULTING

FOR QUALITY MANAGEMENT

CONSILIO ET OPERA consults your quality management department on the following topics:

Initial setup of a lean QMS according to ISO 9001, ISO 13485, MDR, IVDR, FDA 21 CFR part 820 or Medical Device Single Audit Program (MDSAP)
Development of resource-saving integrated management systems (e.g., ISO 9001, ISO 14001 and / or ISO 50001)
Further development of a QMS compliant to ISO 9001 towards ISO 13485 compliance
Further development of the quality policy in cooperation with the management board
Optimization of QM-processes towards leanness and efficiency

FOR REGULATORY AFFAIRS

Your regulatory affairs department is consulted by CONSILIO ET OPERA on the:

Development of options for action with regards to product registration strategies
Revision of documents required for the conformity assessment / registration of medical devices / in vitro medical devices
Assessment of claims on medical devices / in vitro medical devices and elaboration of recommendations on compliant communication

FOR SALES AND MARKETING

The sales and marketing consulting provided by CONSILIO ET OPERA includes:

Planning of the sales and marketing strategy
Preparation of product launches
Process optimization and performance management in sales and marketing

FOR STRATEGIC BUSINESS UNIT MANAGEMENT

The strategic business unit management is supported by the following offer:

Analysis and further development of the overall strategy
Implementation of measures to support medical device / in vitro diagnostic medical device portfolio already on the market
Initiation of new medical devices / in vitro diagnostic medical devices developments based on customer requirements
Optimization of processes with cross-functional teams aiming at lean administration und lean production

CONSILIO ET OPERA GUARANTEES

WARRANTY OF CONFIDENCE

If your company has signed a service contract and is not a 100 % satisfied with our performance, it is free to terminate it with immediate effect.

TELEPHONE SUPPORT

Once your company has given a mandate for consulting or project / interim management it will receive a voucher for 2 hours of telephone consultation in addition to each weekly working contingent (40 hours) ordered. A voucher can be redeemed within one year of issue.

OUR QUALITY MANAGEMENT SYSTEM

PERSONNEL SEARCH

Our strategic alliance partners include independent personnel agencies and freelancers. This offers you the advantage that we can support your personnel search through our network also when you are dealing with large projects. The precondition for this, however, is that our company will be engaged in the same project as these additional external human resources.

YOUR GOALS ARE OUR MISSION

YOUR GOALS ARE OUR MISSION