Product Life Cycle Management
A Tech Transfer is a complex multi-stakeholder process that requires management by experienced consultants and PMs. Inadequate Project Management (i.e. unrealistic timing, poor communication, lacking risk visibility, no budget control and financial insight, ...) is the recipe for project delay that causes negative financial impact for both sending and receiving parties. Modis can lead you efficiently through this trajectory by providing vigorous Project Management, applying our PMBOK based Fast Track To Value methodology.
Regulatory & Compliance Management
Due to the fast-changing regulations in the Medical Devices & Diagnostics industry it can be a challenge to remain compliant. Modis has a proven track in supporting customers in the roadmap to certification and/or compliancy in:
- Quality Management (System) & Product certification: QMS, ISO13485 & CE mark
- MDD & MDR (EU): Complying to Medical Device Regulation requirements
- MDSAP (FDA)
- Good Laboratory Practices / Good Manufacturing Practices
Content & Data Management
Bringing an idea to market does not only rely on efficient and good-quality production, it also requires streamlined Content & Data Management. Modis can help you manage your regulatory data from the start, provide support in QMS documentation, and assist you in setting up trial and submission data:
- eTMF (electronic Trial Master File)
- RIM (Regulatory registration, submission, publishing and archiving)
It is no secret that start- & scale-ups have many activities running in parallel, resulting in large amounts of data. Modis can help to structure data, and to handle and maintain it. We can for example build tailor-made data repositories through SharePoint. Modis also has a broad expertise in data analysis and visualization, turning data into information, enabling you to make the right strategic decisions. Our success stories in Data Management, Analytics & Visualization include custom dashboards and cloud reporting solutions such as PowerBI, Tableau and VEEVA.