MDR compliance
Classification, choosing the conformity assessment route, building the technical file to Annex II and III, and managing the submission.
MDR (AB) 2017/745 · Md.10 · Ek-I
MDR (AB) 2017/745 · IVDR (AB) 2017/746 · ISO 13485:2016
From concept to CE marking,
every step of the route.
EXCOPAN guides medical device and in vitro diagnostic manufacturers from classification through Notified Body assessment. Over 20 years of field experience across Turkish and European Union regulation.
Conformity route
Conformity route
- 01 Classification
- 02 Quality management system
- 03 Technical documentation
- 04 Clinical evaluation
- 05 Notified body
- 06 CE marking
Approach /01
What does it mean to be
an ecosystem company?
Regulatory consulting alone is not enough. Bringing a device to market means the quality system, clinical evidence, technical file, training and funding all have to move at once. EXCOPAN holds those pieces in one place.
We support startups in real time on the ground, and open high-technology opportunities to established manufacturers through detailed analysis. Our goal is not only to solve the problem — it is for your team to solve the next one alone.
20+Years in the field
I – IIIMedical device classes
A – DIVD classes
2Offices · Istanbul
Services /02
Wherever your file is stuck,
that is where we start.
IVDR compliance
Performance evaluation plan, scientific validity report and the Annex IX route for Class A–D in vitro diagnostics.
IVDR (AB) 2017/746 · Ek-XIII
FDA and market access
End-to-end management of registration, 510(k) submission and quality system regulation compliance in the US and other target markets.
21 CFR 820 · 510(k)
ISO 13485 quality system
Building the quality management system from scratch, clause-by-clause training, internal auditor development and audit readiness.
ISO 13485:2016 · GMP
Clinical investigation
Running the clinical investigation from planning to completion; academic and commercial, retrospective and prospective studies.
RG 29111 · ISO 14155
Risk management and training
Risk management file, process optimisation and company-specific awareness programmes — a curriculum proven in development agency programmes.
ISO 14971:2019
Also: verification and qualification · grant support and financial management · international fairs and congresses · technical process management
Ecosystem · Software /03
MedReg AI LiveBuild your technical file
bound to its sources.
MedReg AI produces the GSPR section of your CE technical documentation from the regulatory documents you upload, traceable line by line. The model answers only from those documents; with no source it says "not found" rather than answering. That is what you defend in a Notified Body audit.
- CitationEvery sentence is bound to a source. The clause it came from is printed under the answer.
- OutputDownloads as a Word file. It drops straight into your dossier.
- LimitNo content outside the sources. It closes off the risk of invented answers.
Ecosystem /04
One centre,
five channels.
Consulting, academy and software share one pool of knowledge. Everything we learn in the field goes into training, and every question training raises goes back into the software.
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MedReg AI ↗ Live
Technical documentation bound to regulatory sources — medregai.com
-
Makdos Tech ↗ Development
The software team building MedReg AI and the digital tools
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Academy Training
Courses, workshops, company-specific training programmes and sector surveys
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Clinical research network Field
Investigator and site network for planning, running and evaluating studies
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Accelerator programmes Partner
Commercialisation and compliance programmes run with development agencies
From the field /05
We teach the most boring subject
on earth — without being boring.
TechAnkara
We ran the training track of the Pharmaceutical, Medical Device and Medical Products Accelerator Programme; it closed with a certificate ceremony.
ANKARAKA
40 companies were briefed on medical device regulation and received participation certificates.
OKA
The Middle Black Sea Development Agency programme "Compliance with Medical Device Standards in the Health Sector" ran with strong attendance.
Ankara Kalkınma Ajansı
A company-specific curriculum was prepared for the Medical Device Commercialisation Training Programme.
FAQ /06
The questions we hear
first, and most often.
I don't know which class my device is in — can I still start?
Yes. Just write what the device does and we will classify it. Our scope covers Class I – III medical devices and Class A – D in vitro diagnostics.
What are the steps on the way to the CE marking?
Six: classification, quality management system, technical documentation, clinical evaluation, notified body and CE marking. We start wherever your file is stuck.
What do you do under the MDR?
Classification, choosing the conformity assessment route, building the technical file to Annex II and III, and managing the submission. Basis: MDR (EU) 2017/745, Article 10 and Annex I.
What services do you provide for in vitro diagnostics?
Performance evaluation plan, scientific validity report and the Annex IX route for Class A – D in vitro diagnostics. Basis: IVDR (EU) 2017/746, Annex XIII.
We also want to enter the US market — do you manage the FDA process?
Yes. We manage registration, the 510(k) submission and quality system regulation (21 CFR 820) compliance end to end, in the US and other target markets.
Can you build an ISO 13485 quality management system from scratch?
Yes. Building the system from scratch, clause-by-clause training, internal auditor development and audit readiness are all in scope.
Can our own team produce the technical documentation?
With MedReg AI, yes. It produces the GSPR section of your technical documentation from the regulatory sources you upload, traceable and cited line by line; with no source it does not invent an answer.
How quickly do you reply?
We reply within one business day.