Medical Device & Invitro Diagnostic Device Consulting
Medical Device & Invitro Diagnostic Device Consulting
At FiunEx, we serve as your trusted partner in navigating the intricate landscape of medical device and in vitro diagnostic (IVD) device development and regulation. We provide a wide range of comprehensive consulting services to accompany you throughout the entire product lifecycle, from the initial concept to achieving success in the market.
FiunEx's Medical Device & In Vitro Diagnostic Device Consulting services encompass a comprehensive array of offerings meticulously customized to address your regulatory and compliance requirements. Our dedicated team specializes in guiding you through the complex world of medical device and in vitro diagnostic device regulations, ensuring that your products adhere to the highest standards. Our team of experts is fully committed to aiding you in bringing safe, effective, and innovative medical technologies to patients worldwide.
Services
USFDA Regulatory Support
510(k) Submissions
Breakthrough Device Program Submissions
De Novo Submissions
FDA Regulatory Strategy
IDE Clinical Study Submissions and Reports
Premarket Approval (PMA) Submissions
Q-Submissions
Summary of Technical Documentation (STeD) Submissions
U.S. FDA 483 Mitigation Projects and Strategies
Product Approval Support (EU-MDR, IVDR & UKCA)
Preparation and submission of regulatory documentation, including technical files and design dossiers.
Registration for product applications and clinical investigation applications
Writing and updating clinical evaluation reports (CERs)
Liaison with European competent authorities and notified bodies, and UK approval bodies.
Implementation of EU Medical Device Regulation (EU 2017/745), In Vitro Diagnostic Medical Devices Regulation (EU 2017/746), and UK Medical Device Regulation (UK MDR)
Medical device qualification and classification
Determination of labelling requirements
Support with regulatory/medical device quality management system (QMS) gap analysis
Acting as your Person responsible for Regulatory Compliance (PRRC) as required under article 15 of the MDR.
Assistance for Drug/Device Combination Device Manufacturers under Rule 14
Assistance for Manufacturers of In Vivo Origin Products (EU Regulation 722/2012 & EN ISO 22442)
Conformity Assessment Procedures under MDR 2017/745
Device Classification and Regulatory Pathway Consulting
MDR Technical Documentation Gap Analyses
Notified Body Observations and Non-Conformity Responses
Notified Body Selection
Reprocessing of Disposable Products under MDR
Technical Documentation Compilation
Unique Device Identifier (UDI) Support