Project and Interim Management, Consulting and Training on Management Systems, Regulatory Affairs, and Process Optimisation in Medical Technology, In Vitro Diagnostics, Life Sciences, Pharmaceuticals, Chemicals, Mechanical Engineering, and the Metal and Electrical Industries
At CONSILIO ET OPERA GMBH, we specialise in Quality Management Systems and Regulatory Affairs Consulting for companies across medical technology, life sciences, pharmaceuticals, chemicals, and other industrial sectors.
Project and Interim Management for Management Systems and Regulatory Affairs in Medical Technology, Life Sciences, Pharmaceuticals, Chemicals and Other Industrial Sectors
With many years of hands-on experience in project and interim management, CONSILIO ET OPERA supports companies across a wide range of industries in building, maintaining, developing and integrating management systems tailored to their operational and regulatory needs.
Our expert services cover:
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Quality Management (ISO 9001, ISO 13485)
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Environmental Management (ISO 14001, EMAS)
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Sustainability Management (CSRD / ESRS)
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Energy Management (ISO 50001)
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Occupational Health & Safety Management (ISO 45001)
In the medical technology and in vitro diagnostics sectors, we additionally manage projects in Regulatory Affairs, Marketing and Sales, ensuring full compliance with MDR and IVDR requirements. Our goal is to help clients achieve regulatory compliance, market access, and sustained competitiveness in a complex and evolving landscape.
Consulting for Management Systems and Regulatory Affairs in Life Sciences, Medical Technology, In Vitro Diagnostics, Pharmaceuticals, Chemicals, Mechanical Engineering, and the Metal & Electrical Industries
CONSILIO ET OPERA provides cross-industry consulting services for manufacturers and distributors of medical devices, companies in the pharmaceutical and chemical industries, as well as organisations from mechanical engineering and the metal and electrical sectors.
Our expertise focuses on the implementation, optimisation, and integration of management systems, including:
-
Quality Management (ISO 9001, ISO 13485)
-
Environmental Management (ISO 14001, EMAS)
-
Sustainability Management (CSRD / ESRS)
-
Energy Management (ISO 50001)
-
Occupational Health & Safety Management (ISO 45001)
In the medical technology and in vitro diagnostics fields, we also offer specialised consulting in Regulatory Affairs, supporting clients in meeting MDR and IVDR requirements.
Beyond compliance, we help organisations strengthen their market access, marketing, and sales strategies — ensuring not only regulatory conformity but also long-term competitiveness in demanding markets.
Consulting for Management Systems and Regulatory Affairs in Life Sciences, Medical Technology, In Vitro Diagnostics, Pharmaceuticals, Chemicals, Mechanical Engineering, and the Metal & Electrical Industries
CONSILIO ET OPERA provides cross-industry consulting services for manufacturers and distributors of medical devices, companies in the pharmaceutical and chemical industries, as well as organisations from mechanical engineering and the metal and electrical sectors.
Our expertise focuses on the implementation, optimisation, and integration of management systems, including:
-
Quality Management (ISO 9001, ISO 13485)
-
Environmental Management (ISO 14001, EMAS)
-
Sustainability Management (CSRD / ESRS)
-
Energy Management (ISO 50001)
-
Occupational Health & Safety Management (ISO 45001)
In the medical technology and in vitro diagnostics fields, we also offer specialised consulting in Regulatory Affairs, supporting clients in meeting MDR and IVDR requirements.
Beyond compliance, we help organisations strengthen their market access, marketing, and sales strategies — ensuring not only regulatory conformity but also long-term competitiveness in demanding markets.
Targeted Training to Strengthen Management and Compliance Competence
For clients in Life Sciences, Medical Technology, In Vitro Diagnostics, Pharmaceuticals, Chemicals, Mechanical Engineering, and the Metal and Electrical Industries, CONSILIO ET OPERA offers a selection of specialised training programmes.
Our training portfolio covers essential business and leadership topics including Leadership & Communication, Sales and Go-to-Market Strategies, and Compliance Basics – all designed to be practical, concise, and implementation-focused.
When required, we also deliver foundation and refresher modules on management systems – such as ISO 9001, ISO 14001 / EMAS, CSRD / ESRS, ISO 50001, and ISO 45001 – as well as Regulatory Affairs for medical devices and in vitro diagnostics (MDR / IVDR).
These modules are typically integrated into ongoing client projects, ensuring maximum relevance and immediate applicability in day-to-day operations.
