Get your medical device
EU MDR ready
Scientific consulting guides medical device manufacturers through EU MDR compliance,
clinical evaluation and PMCF.
THE CHALLENGE
EU MDR is where market
access stalls.
Most delays do not come from the science. They come from documentation, evidence and process gaps that surface only when a notified body reads the file.
Time and capacity loss
Internal teams spend months on documentation that should take weeks, while product development waits on the sidelines.
Rejection risk
Gaps in clinical evidence or literature search methodology remain the most common reason notified bodies send files back
Fragmented expertise
Regulatory, clinical and quality knowledge often sit with different consultants who never quite talk to each other.
Scaling constraints
As your portfolio grows, hiring an in house specialist for every requirement becomes slow and expensive.
WHY SCIENTIFIC CONSULTING ?
Regulatory rigor with real
clinical judgment
Founded in 2020, by regulatory and clinical specialists
Clinical judgment, not just paperwork
Our team includes qualified physicians with hands on experience in cardiology, pulmonology and pediatrics, not only regulatory writers.
A North African structure built for rigor
Headquartered in Tunis, Tunisia, and built on rigorous standards of quality and documentation discipline.
A team that speaks your language
English, French and Arabic are spoken natively across the team, not translated after the fact.
Weeks, not months
A fixed, repeatable process means documentation that would stall an internal team for months moves in a fraction of the time.
WHAT WE DO
Four disciplines, one accountable team
Every service below is delivered by the same team that carries your file to the notified body, not handed off between vendors
Clinical evaluation, clinically sound
Our CERs and state-of-the-art reviews are shaped by clinicians who understand the evidence, not just writers formatting it to a template.
Clinical investigation plans
Clinical Investigation Plans and Statistical Analysis Plans built for real world study execution.
QMS support (ISO 13485)
Quality management system documentation and process support aligned with ISO 13485.
PMCF planning & execution
Post market clinical follow up plans and reports, from protocol design through to field data collection.
GET IN TOUCH
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