EU MDR 2017/745 Specialists
EU MDR Compliance. Simplified.
Expert medical device regulatory consulting — CE Marking, MDR Technical Files, Clinical Evaluation, Risk Management.
ISO 13485 · EU MDR 2017/745 · CE Marking · ISO 14971 · MEDDEV 2.7.1
500+
Devices Certified
15+
Years Experience
30+
Countries
98%
Client Satisfaction
Trusted by medical device manufacturers worldwide
MedTech AG
BioCare
OrthoNova
CardioPlus
DentaLab
ImplantPro
NeuroSys
VitalCare
Our Services
End-to-end medical device regulatory consulting under EU MDR 2017/745.
Real Outcomes for Our Clients
80%
Compliance gap reduction in the first MDR audit cycle
— Class IIb Orthopedic, Germany
6 weeks
Time to clear an FDA 483 observation
— Class II Diagnostic, USA
0 NCs
Major non-conformities at last surveillance audit
— Class III Cardiovascular, EU
Why Choose MEGACERT
Notified Body Experience
Our consultants have worked inside notified bodies — we know how reviewers think.
End-to-End Service
From device design input to CE marking approval and post-market surveillance.
Multilingual Support
Turkish, English, German — serving EU and Turkish markets seamlessly.
"
MEGACERT guided us through MDR transition flawlessly. Their team's depth in technical documentation and clinical evaluation is unmatched.