Regulatory Affairs / Quality Management

Regulatory Affairs & Quality Management

The ever growing regulatory compliance requirements necessitate higher standards of documentation and processes and a cross functional effort from organisations.

At Evnia we provide Regulatory & Quality management to help you develop and implement strategies to ensure regulatory compliance. Together we ensure that necessary documentation is completed and submitted timely.

Our Regulatory Affairs & Quality management services can influence the standards and operating procedures and we can help you develop compliant company policies

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.

Project & Interim Management

Effective Project Management is key for both daily operations and MDR and IVDR transition activities.

Medical Device, Biotech & Pharma projects require cross-functional expertise and activities that ultimately affect 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 organisations to help ensure a holistic approach to the needs and unique business requirements of your organisation.

Contact us today by going to our contact page or call us at +45 88 82 57 97 to evaluate your needs towards achieving regulatory compliance.