Who we are and what drives us
CONSILIO ET OPERA GMBH has been founded in 2017 and works together with companies from various industries (e.g. medical technology, in vitro diagnostics, chemistry, pharmaceuticals, life sciences, mechanical engineering, metal, electrical engineering).
The spectrum of customers ranges from small start-up companies to huge global players. CONSILIO ET OPERA offers consulting services as well as interim management and training on management systems, regulatory affairs, marketing and sales as well as the management of strategic business units. We also perform project management tasks with cross-functional teams. Furthermore, our services include project management with cross-functional teams. Each and every customer or matter in question is important to us.
Standards of Quality
CONSILIO ET OPERA combines a high quality standard with its services and underpins this by the fact that we, as a management consultancy, maintain and continuously develop our own quality management system in accordance with ISO 9001.
System of values
The supporting pillars of our value system are permanent further qualification, loyalty and reliability. On this basis, we constantly optimize our range of services according to changing customer requirements. We like to be down-to-earth, at eye level with our customers and develop lean, practical solutions at a fair price-performance ratio.
Memberships
We are a member of the Interest group of medium-sized companies and liberal professions e.V. (Interessenverband Mittelständischer Unternehmen und Freier Berufe e.V. (IMU)), the Karlsruhe Chamber of Industry and Commerce and the Association for Electrical, Electronic & Information Technologies (VDE). As a supporting member of the Jugendfarm Schwarzach, a facility of the Johannes-Diakonie Mosbach, and the Frankfurt Zoological Society (FZS), we show social and ecological commitment.
Project successes
Below we present a selection of projects, which have recently been successfully implemented by CONSILIO ET OPERA in the supported industries.
Medical technology
Management of a project to meet the requirements of MDR (Regulation (EU) 2017 / 745) with regards to product labelling and instructions for use at a large, globally active manufacturer of medical devices. As part of the cross-functional project, solutions for different types of packaging (individual products, several products of the same type, different products, systems) were also developed based on corresponding GAP analyses. In addition, relevant QMS documents were revised and useful guidelines were created to support daily work.
In-vitro-diagnostics
Interim management of the Quality Assurance & Regulatory Affairs department as well as assuming the roles as Quality Management Representative (QMR) according to ISO 1345 and as Responsible Person for Regulatory Compliance (PRRC) according to Article 15 of the IVDR (Regulation (EU) 2017 / 746) for the German subsidiary of a major US manufacturer of in-vitro diagnostics. The focus was on actively supporting the compliant transition of the existing in-vitro diagnostics portfolio from IVDD to IVDR.
Life Sciences
Consulting and performance of interim management tasks at a start-up company from the life sciences. The project focused on the documentation and preparation of results from the Research and Development department as well as the further development of the quality management system according to IVDR and ISO 13485.
Pharmaceutical
Support of the project management of a renowned pharmaceutical manufacturer and its partners in the market-ready development of a digital health application (DiGA) for a behaviour therapy and the preparation of the corresponding assessment by the Federal Institute for Drugs and Medical Devices (BfArM) according to the Fast Track procedure.
Chemistry
Consulting and interim management for a medium-sized chemical company in the implementation of an integrated management system based on ISO 9001 and ISO 14001. To streamline the QMS system, all necessary documents were adapted and the employees were trained accordingly. The subsequent audit by the certifier was prepared, accompanied and finally followed up.
Martin Lempert
Founder and Managing Director
of CONSILIO ET OPERA
Martin Lempert has many years’ professional experience in regulated industries (e.g. medical devices, in vitro diagnostics and life sciences), including senior positions. He has pursued extensive professional development in Lean Six Sigma; various management systems (e.g. ISO 9001, ISO 13485, ISO 14971, ISO 14001, ISO 50001, ISO 45001); regulatory affairs (e.g. MDR, IVDR, CSRD / ESRS); as well as marketing and sales. Today, he supports CONSILIO ET OPERA’s clients not only as a senior consultant but also as a project and interim manager: he drives the implementation and integration of management systems, helps with conformity assessment and CE marking, facilitates audits and ensures regulatory compliance—efficiently, pragmatically and measurably.
Let’s tackle it
We always offer you a personal meeting (duration approx. 1 h) free of charge, also gladly via video conference, to get to know each other and to gain a first insight into your current company situation.
During this meeting we will also inform you in detail about our general terms and conditions of sale.
