As DeSia, we specialise in providing services to medical device manufacturers, ranging from start-ups to corporate companies and entities producing different medical devices operating worldwide.
Our services include but not limited to:
- Quality management system compliance under ISO13485 and MDSAP,
- Technical consultancy within the framework of MDR and IVDR
- Designing pre and post-market clinical studies related to Clinical Safety and Performance and to provide relevant documentation
- Conducting Clinical Trials and Performance Evaluation Tests
- Usability Engineering Studies in medical devices and
- Preparation of Protocols and Reports of Validations of the manufacturing processes of the devices
- Conducting simulation tests for Transportation Validation in our state-of-the-art laboratory,
- Software Validation
- Biocompatibility Assessment
Here's how we can assist you:
Expert Guidance: Our seasoned professionals teamed in different subjects bring years of experience in medical device compliance. We'll provide you with the expert guidance in Quality, Regulatory and Clinical affairs to navigate the intricacies of MDR and IVDR with confidence.
Tailored Strategies: We understand that each client is unique. We'll work closely with your team to develop personalized strategies that align with your product portfolio, ensuring compliance while minimizing disruption.
Documentation Support: We'll assist you in preparing and organizing the necessary documentation to meet MDR and IVDR requirements, helping you maintain a meticulous record of your regulatory journey.
Ongoing Support: Our commitment doesn't end with certification. We'll be with you to provide continued support, ensuring you remain compliant and ready for future regulatory challenges.
