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.



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


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