80%
Compliance gap reduction in the first MDR audit cycle
Class IIb orthopedic device · Germany
EU MDR 2017/745 Regulatory Specialists
Move Your Medical Device to EU Market with MDR-Ready Documentation
MEGACERT helps medical device manufacturers prepare audit-ready technical files, clinical evaluations and quality systems for a clearer path to CE marking.
Tell us about your device — our team responds within 24 hours.
Built for notified body review
End-to-end documentation support
EU and Türkiye market expertise
500+
Devices Certified
15+
Years Experience
30+
Countries
98%
Client Satisfaction
Trusted by medical device manufacturers worldwide
EU MDR 2017/745
ISO 13485
ISO 14971
ISO 10993
MEDDEV 2.7.1
Our Services
End-to-end medical device regulatory consulting under EU MDR 2017/745.
Real Outcomes for Our Clients
6 weeks
Time to clear an FDA 483 observation
Class II diagnostic device · USA
0 NCs
Major non-conformities at last surveillance audit
Class III cardiovascular device · 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.
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MEGACERT guided us through MDR transition flawlessly. Their team's depth in technical documentation and clinical evaluation is unmatched.