Services
Together we discuss your problem and formulate a service description including a cost estimate. Within the framework of the resulting consulting contract, we implement the task and inform you about the progress of the project. You will receive a work result in the previously agreed form.
Regulatory Affairs
The manufacturer obligations as well as requirements for distributors, importers and users of medical devices are multifaceted. With many years of experience in shaping regulatory and technical requirements as well as verifying compliance with existing requirements, we have broad expertise in a wide range of areas.
These include, for example:
- Documentation
Support in the creation, maintenance, review of technical documentation, fiduciary management of documentation - Clinical evaluation
Creation and maintenance of clinical evaluations - Supplier management
Selection, quality assurance agreements (QAA), qualification and monitoring (audit) - Qualification
Process validations, equipment qualification, personnel qualification - Process management
Risk management, process planning, auditing of processes - Legal issues
Demarcation of medical devices from other legal areas such as pharmaceuticals, cosmetics, food supplements // Classification of medical devices // Preparation of expert opinions in disputes with competitors, BS or authorities - Contract drafting and review
Supplier contracts, distribution contracts - Due Diligence
Assessment of company assets with regard to regulatory and technical compliance in the context of M&A processes
Mode of operation
We advise you individually, comprehensively and legally. You will not receive sample solutions or prefabricated main stream answers. Should we reach our limits in terms of content, we will identify them and reinforce the project team as needed and according to your specifications. You can find more details in our terms and conditions (GTC).