CONFORMITY ASSESSMENT BODY · MEDICAL DEVICES
Medical device certification: rigorous, clear, predictable.
CertExe is a conformity assessment body dedicated to medical devices: agile, focused and committed to open dialogue with manufacturers. We are currently seeking designation as a Notified Body under Regulation (EU) 2017/745 and accreditation from Accredia for ISO 13485 certification. We work independently and impartially, giving manufacturers clear points of contact, realistic timelines and transparent pricing.
ABOUT US
Built on expertise.
CertExe was founded by professionals who spent many years at different Notified Bodies, assessing technical documentation and quality management systems for medical device manufacturers. We have brought together our expertise, our methods and a shared vision to create a new kind of body: one that keeps the rigour we know well, while improving what we always knew could work better from the inside, namely communication, timelines and a clear path to certification.
We are currently seeking designation as a Notified Body under Regulation (EU) 2017/745 (MDR) and accreditation from Accredia for ISO 13485 certification; in the future, we plan to extend our scope to in vitro diagnostic medical devices (IVDR). We are based in Italy and work with manufacturers from all over the world who need CE marking to place their devices on the European market.
We believe in a specialised body with hands-on management and carefully selected expertise; as a result, every manufacturer works with people who know their device and their file inside out.
OUR JOURNEY
Where we stand today, in full transparency.
01
Company incorporation and management system
DONE
02
Applications submitted to Accredia (ISO 13485) and the Italian Ministry of Health (MDR)
DONE
03
Review of the applications
IN PROGRESS
04
First ISO 13485 certification audits
IN PREPARATION
05
Accredia assessments
PLANNED
06
ISO 13485 accreditation
PLANNED
07
MDR joint assessment by the Ministry of Health and the Joint Assessment Team
PLANNED
08
MDR designation and notification
PLANNED
09
Extension to the IVDR
PLANNED
CERTIFICATION SERVICES
One approach, whatever the scheme.
OPEN TO OUR FIRST CLIENTS
ISO 13485
ISO 13485 quality management system certification for medical device manufacturers, with Accredia accreditation in progress. Designed for start-ups and small companies, whether they make their own devices or work with third parties.
Our first clients benefit from preferential terms and, once accreditation is granted, free conversion of their certificate to accredited status.
DESIGNATION IN PROGRESS
MDR
Assessment of technical and clinical documentation, quality management system audits and certification decisions for the CE marking of medical devices under Regulation (EU) 2017/745, within the scope of our future designation.
Register your interest now to plan ahead.
COMING SOON
IVDR
In the future, we plan to extend our services to in vitro diagnostic medical devices under Regulation (EU) 2017/746.
HOW WE WORK
Expertise, responsiveness, transparency, predictability.
Manufacturers always know who is handling their file, where things stand and what comes next.
Dedicated onboarding
A structured start to agree scope, expected documents and timelines.
Completeness check
We make sure your file is complete and easy to navigate before the review begins.
Structured dialogue
Clear questions and findings, managed through a single tracked channel.
Dedicated coordinator
A single point of contact who knows your project from day one.
Realistic planning
Honest time estimates, updated if anything changes.
Transparent pricing
Activities and costs clearly set out from the quotation onwards.
We assess. We do not consult.
CertExe does not provide consultancy of any kind, either on devices or on management systems. Our training courses are general and not tailored to individual companies; technical responsibility for assessments and certification decisions is fully independent of management.
TRAINING
Regulatory training on the MDR and ISO 13485.
Free guides, recorded webinars and live courses, in English and Italian, delivered by professionals with first-hand Notified Body experience. Learn the requirements, the language and the expectations of those who assess conformity.
NEWS