PROJECT AND INTERIM MANAGEMENT ACCORDING TO YOUR NEEDS
In the course of our project management activities we are steering ad interim also cross-functional teams in order to meet project goals on time. Project management is performed according to your requirements in a classical, agile or hybrid manner. For our work we use well established concepts and best practices to achieve optimum results. Associated project risks are analyzed, assessed and finally risk management measures are implemented. CONSILIO ET OPERA GMBH specializes in the following areas of interim management and the assumption of corporate functions: quality management, environmental management, sustainability management, energy management, occupational health and safety management, regulatory affairs, marketing and sales as well as the management of strategic business units. Our project and interim managers have the necessary practical experience and are also well prepared for their tasks with both internal and external, partly certified, training measures.
IN QUALITY MANAGEMENT
CONSILIO ET OPERA helps companies from various industries (e.g. medical technology, pharmaceuticals, chemistry, life sciences, mechanical engineering, metal, electrical engineering) to set up, maintain and further develop their quality management system (QMS). This is done in accordance with regulatory requirements or international standards as well as relevant guidelines and involves the following offer on our part:
IN ENVIRONMENTAL MANAGEMENT, EMAS AND SUSTAINABILITY MANAGEMENT
CONSILIO ET OPERA ensures an efficient first-time installation, maintenance and continuous optimization of your environmental management system (EMS) according to ISO 14001 as well as the fulfilment of the further requirements according to the Eco-Management and Audit Scheme “(EMAS). We also support you in setting up non-financial sustainability reporting in accordance with the Corporate Sustainability Reporting Directive (CSRD) based on the European Sustainability Reporting Standards (ESRS). The tasks performed include:
Regarding ISO 14001
When expanding an existing environmental management system according to ISO 14001 to meet the requirements of EMAS
When implementing a sustainability management system in the context of CSRD/ESRS and the associated non-financial sustainability reporting
IN ENERGY MANAGEMENT
The initial establishment, maintenance and improvement of an energy management system (EnMS) according to ISO 50001 is carried out by CONSILIO ET OPERA for your company with the following measures, among others:
MANAGEMENT OF SAFETY AND HEALTH AT WORK
In establishing, maintaining and continuously improving your occupational health and safety management system (OH&S-MS) in accordance with ISO 45001, CONSILIO ET OPERA performs the following tasks, for example:
IN REGULATORY AFFAIRS
In the sector of regulatory affairs CONSILIO ET OPERA GMBH supports medical technology and in-vitro diagnostics companies particularly to meet the requirements of EU MDR (REGULATION (EU) 2017/745), EU IVDR (REGULATION (EU) 2017/746), FDA (listing, 510k clearance, PMA approval), MHRA and Swissmedic. Our services comprise:
IN SALES AND MARKETING AND IN STRATEGIC BUSINESS UNIT MANAGEMENT
CONSILIO ET OPERA offers manufacturers and distributors of classic medical devices, software as a medical device, digital health applications (DiGA) and in vitro diagnostics the following services in marketing and sales as well as the management of strategic business units:
YOUR GOALS ARE OUR MISSION
YOUR GOALS ARE OUR MISSION
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.
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.