We work with a broad range of medical device companies, supporting their regulatory strategy for EU and US market access.
We provide insights, guidance, and services to help you achieve your regulatory goals.
Regulatory Consulting
QualityMedDev provides consulting services over a broad range of topics related to the EU Medical Device and In-Vitro Diagnostic Regulation, US market and FDA regulations (such as support on 510k, De-Novo, Q-Submission). These topics range from technical documentation preparation to risk management, usability, biocompatibility and Post-Market Surveillance.
We provide as well services related to ISO 13485 certifications and Quality Management System implementation and maintenance.
Technical Documentation Preparation according to EU MDR and IVDR
As part of our MDR Consulting Service, QualityMedDev supports the preparation of technical file or part of the technical file in compliance with EU Medical Device and In-vitro Diagnostic Regulation.
ISO 14971 : Risk Management
QualityMedDev can support the organization in the implementation of an efficient risk management system, including preparation of all the dedicated documentation according to ISO 14971 .
PRRC – Person Responsible for Regulatory Compliance
We can provide specific training to the person(s) appointed as PRRC; if you prefer, we can give you availability of one of our consultants to act as PRRC for your organization.
QMS / ISO 13485 Consulting
QMS Implementation
Do you need help to build a QMS from scratch? Or do you need support to implement specific processes? QualityMedDev can help your organization to achieve these goals.
Trainings
We are able to provide a wide range of virtual and on-side trainings over a broad range of topics, such as ISO 13485, EU MDR 2017/745 and IVDR 2017/746, risk management, PMS, etc.
Quality Management ad Interim
We provide support to organisation that for whatever type of reasons have the necessity to outsource the management of their Quality System.
Contact Us
You can contact us through the form below or write an email at the following address: info[at]qualitymeddev.com