Medical Devices and In-Virto Diagnostics
The global regulatory environment for medical devices & IVD is challenging and complex. IPHARMED provides regulatory consulting services for every step of the medical device product lifecycle. Our global expert team will develop the optimal regulatory strategy, depending on the device and market focused by your organization.
Our device scientific writing team can handle all your medical device submission requirements. Our In-depth knowledge in regulations and processes allow us to speed up the medical device registration and submission process.
Let us assist you with:
- EU MDR transition support and Gap Assessments
- Gap assessment for 510(k) or CE Marking documentation to include assessment for Device classification, TF documentation, TF PMS, GSPRs, IFU
- Authoring BERs, CERs for all class of device
- Post-Market Clinical Follow-up study design, and data analysis
- Implementation of Unique Device Identification (UDI) and EUDAMED
- Regulatory Intelligence on country-specific requirements, product classification, clinical trial study requirements, and import regulations
- Creation and updation of PMS and PSUR
- Biocompatibility and Risk Assessments