Loran GmbH
Loran offers specialized advice in the healthcare sector and has many years of experience in the development and monitoring of regulatory requirements in the area of medical devices and medicinal products in the EU. Manufacturers of medical devices and other economic players are offered sound and legally secure advice on strategic alignment issues and their regulatory and technical implementation. Loran has an extensive cooperation network of senior experts in the relevant specialist areas. Loran's clients include manufacturers of medical devices, importers, distributors, suppliers, service providers, associations and M&A companies.
Loran's typical scope of services includes the preparation and maintenance of technical documentation for medical devices in accordance with Annex II of the MDR and related aspects such as planning and monitoring of preclinical performance records and clinical evaluations, preparation and maintenance of QM documentation, including support in supplier management, planning of qualification and validation of production processes (e.g. packaging, sterilization, ...), interpretation of legal issues (regulatory affairs), contract drafting and review, asset valuations as part of due diligence processes and much more.