Regulatory consultancy for the biomedical sector
In the complex regulatory landscape that regulates the medical device sector, ensuring compliance with legislative provisions allows you to operate safely, maintaining competitiveness. Eumed® offers a highly specialized regulatory consultancy service, supporting companies, producers and economic operators in the management of the legal and contractual aspects linked to the marketing and distribution of medical devices.
Our consultancy service in the healthcare, medical devices and biomedical sector in general is divided into specific areas of intervention: contractual drafting and revision to protect relationships with suppliers, distributors and commercial partners; assistance in public tenders providing support for participation in tenders.
Contract drafting and review
Eumed® offers a consultancy service on controversial administrative law issues, providing useful opinions and clarifications. Not only that, often the contracts stipulated by manufacturers, importers and distributors, despite being formally correct, are lacking on a regulatory level, or do not take into consideration aspects of management of commercial and product brands, incurring non-compliance on the part of the Notified Bodies or assumption of responsibility in the placing on the market and in the destination of the devices.
The Eumed® team offers the analysis and drafting service of the main types of contracts in use among economic operators in the medical device sector, which are suitable not only to regulate the legal relationship between the parties but above all to frame the obligations and responsibilities at a regulatory level so as not to incur non-compliance. (sales, subcontracting and brand management contracts falling within art. 16 of EU Regulation 2017/745, OBL, OEM, NDA etc.).
Public tenders and contracts
The management of tenders requires specialized skills and constant regulatory updating, considering the complexity of drafting specifications and specifications and the continuous evolution of regulations and jurisprudence. Companies operating in the biomedical and medical device sectors are faced with increasingly complex procedures, which require attention to technical, regulatory and administrative requirements.
Eumed®, thanks to the partnership with a qualified law firm expert in tender procedure, supports companies in all phases of the process of participation in public procurement.
Evaluation of specifications
We offer support in evaluation of the specifications and tender documentation, in the compilation of ESPD (Single European Procurement Document), in the preparation of clarification notes and in drafting of technical and economic offers.
Training and updating
In addition to direct assistance, we provide regulatory training and updating services for the staff of public administration supplier companies, in collaboration with prestigious ed institutes University bodies.
Consulting
Eumed® provides its Clients with the following consultancy activities relating to the management of public tenders.
- Analysis of tender documents prepared by the Contracting Authorities (tenders, specifications, specifications, related forms, etc.), verification of the clauses inserted and verification of their legitimacy and consistency with the current regulatory system;
- Verification of tender specifications requests relating to medical and in vitro diagnostic devices to verify compliance with standards and compliance with the Client’s products;
- Control of offers and contracts stipulated by the Client with verification and interpretation of the contractual clauses and verification of the existence of national trademarks and patents of the products distributed by the Client, upon his indication and specification.