HIGH LEVEL OF PROFICIENCY IN REGULATORY AFFAIRS AND EXTENSIVE EXPERIENCE
Regulations for medical devices differ substantially from those of pharmaceutical and drug development. With a high level of proficiency in Regulatory Affairs and extensive experience with EU and US medical device regulations, we are able to support you in handling challenges and questions arising throughout your medical device life cycle and help your company navigate regulatory requirements.
Devicia is a member of multiple committees and trade organizations both in the EU and the US. As a nominated expert in the ISO/Technical Committee 194 Working Group 4, Devicia works with the globally recognized ISO 14155 standard governing clinical investigations of medical devices in humans. Thus, we can provide you with the very latest insights on new regulations, as well as delivering strategic input for future trends in medical device requirements.
Our services include:
– Clinical Quality Management Systems (ISO 14155)
– Strategic Advice
– Clinical Regulatory Affairs
– Clinical Due Diligence
– Clinical Regulatory Guidance, such as gap analysis and interpretation of clinical data requirements
– Project Management
– Clinical Regulatory Expertise
– Clinical Development Strategy