Regulatory Affairs Management
What is Regulatory Affairs Management
As more and more medical device manufacturers seek help from subject matter experts in regulatory compliance, Evnia is offering specialised services to help companies manage complex documentation processes.
Regulatory Affairs & Quality Management
With the ever-growing regulatory compliance requirements, your organisation needs to meet higher standards of documentation and processes, as well as make a cross-functional effort.
At Evnia, we provide Regulatory & Quality Management services to help you develop and implement strategies that tackle regulatory compliance from day one. Together, we ensure that necessary documentation is completed and submitted in a timely manner.
MDR Response Team
In an effort to ensure MDR compliance, the Notified Body (NB) has ongoing surveillance processes of manufacturers’ regulatory documentation. The documentation upkeep is a cross-functional activity that requires precision and coordination to ensure that NB assessment and questions are proceeding smoothly and without interruptions.
Through Evnia’s MDR Response Team, you will be fully supported to respond to the NB audits and requests in a timely and precise manner to ensure a successful outcome.
Clinical Evaluation Report VIP Service
Within this VIP service, the Clinical Evaluation Reports, prepared by Evnia, can be reviewed by an ex Notified Body professional.
Manufacturers get a competitive advantage through a holistic approach towards
- Quality management systems
- Pre-clinical and clinical documentation requirements of the MDR
- Performance evaluation requirements of the IVDR
- Adequate training and industry events
Project & Interim Management
Effective project management is key for both daily operations and MDR & IVDR transition activities.
Medical Device, Biotech & Pharma projects require cross-functional expertise that ultimately affects all levels of an organisation, particularly within risk management. It is, therefore, critical to handle these activities with optimal transparency and effective leadership.
At Evnia, we provide project management and interim management services for Medical Device, Biotech and Pharma organizations to help ensure a holistic approach to the needs and unique business requirements of your organisation.
Need more details?
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