With 15+ years experience our experts will provide tailored solutions for your project. Whether you are a small start-up, requiring an effective regulatory watch or a mature company looking for detailed information about the revised regulatory requirements, you’ll find a good solution within MEDLOFT.
We will provide you the effective and on time consultancy and manage your RA & QA processes so that you will comply with the regulations and have an effective quality management system for your product realization processes.
To define details of your current processes and review present functions against applicable legal requirements and standards a gap analysis will be performed at the initial stages. A detailed report will be prepared according to findings of this analysis and presented to the top management together with a project plan proposal.
A dedicated MEDLOFT expert, giving you access to a broad team with all expertise, will manage your project according to your needs. Site visits will be performed as defined within the project plan and your team will be supported continuously with online communication tools (email, video conference etc.). At the end of each month the status of the project will be reported to the top management.
During the consultancy services, all activities of your company will be analysed and appropriate quality management system requirements together with organizational benefits will be implemented according to your company profile.
All information exchanged between your company and MEDLOFT will be kept confidential. It will be never shared with third parties. This is a commitment given in MEDLOFT policy and confidentiality agreement will be signed at the beginning of the project.
To have more detailed information about our consultancy services please contact us…