Medical device

Experienced in the regulatory requirements for clinical investigations of medical and in-vitro diagnostic devices, we assist you in designing, implementing and managing a clinical development program for your medical device (pre- and post-marketing).

THE PATH FROM DESIGN TO MARKETING OF
A NEW MEDICAL DEVICE (MD OR IVDMD)
CAN BE BLURRED AND COMPLEX

Regulations and requirements vary by region, by country, level of risk, product-specific claims and intended use.

With a comprehensive experience in all types of medical devices, our MD team includes:

Project managers
Clinical monitors
Data managers
Biostatisticians
Regulatory and QA experts
Medical writers

They can assist you:

in designing, implementing, and managing a clinical development program (pilot/proof of concept, confirmatory, Post-Marketing Clinical Follow-up)
regardless of the type of medical device (MD, IVDMD, “combined” device (MD + drug), connected MD, software as a medical device)
whether you aim at supporting a pre-marketing regulatory submission (i.e. CE mark package for a Notified Body), supporting product reimbursement, or monitoring post-market product use (Post-Marketing Clinical Follow-up / PMCF).

INTERVENTIONAL STUDIES

Pilot studies
Confirmatory studies (Pre and Post Market)
Innovation Post-Authorisation Safety Studies (PASS)

NON INTERVENTIONAL STUDIES

PMCF studies
Post-marketing registries
Health economic assessments
Materiovigilance reporting

Patient centered studies
Health Systems database
Analyses (SNDS…)

OUR SERVICES

CONSULTING IN MEDICAL DEVICE DEVELOPMENT

Literature reviews
Clinical and regulatory strategy
Trial design and validation

Product / Risk classification
Early feasibility studies
Risk management

PRE- / POST-MARKETING CLINICAL INVESTIGATIONS

Design and medical writing
Regulatory submissions
Clinical investigation management and follow-up

Biometry and data sciences
Safety and PSUR
Clinical study reports

ICTA’s experience encompasses Medical Devices, IVDMDs, “combined” MDs, and software as medical device, used in many indications across a large range of therapeutic areas

THE ICTA RWE TEAM CAN ALSO ASSIST YOU IN DESIGNING

PRE-MARKETING STUDIES
to better understand the use of the medical device in the larger clinical setting and for regulatory decision making

POST-MARKETING STUDIES
for labelling-CE-mark expansion/variation and post-market surveillance (real world studies)

Regardless of the stage of development of your medical device, the ICTA team offers insight, expertise and know-how to help you:

Understand the market and identify the right MD strategy

Set up the overall MD clinical development plan

Assess the safety and performance, and gather data for CE mark/registration

Mitigate risk and keep your MD compliant with regulations and ISO requirements

Medical device

THE PATH FROM DESIGN TO MARKETING OF
A NEW MEDICAL DEVICE (MD OR IVDMD)
CAN BE BLURRED AND COMPLEX