Esra Gündağ — Medical Device Regulatory Consultant
EUmediq is the consultancy practice of Esra Gündağ in medical device and drug-device regulation. It supports manufacturers directly on MDR 2017/745, ISO 13485 and the technical processes attached to them.
Areas of expertise
- Classification, technical documentation and CE marking under MDR 2017/745
- Transition of devices certified under MDD 93/42/EEC to the MDR
- Setting up an ISO 13485 quality management system, internal audits and certification readiness
- Drug-device products and drug-device combinations
- Clinical evaluation (MEDDEV 2.7/1), post-market surveillance (PMS) and post-market clinical follow-up (PMCF)
- ISO 14971 risk management, ISO 10993 biocompatibility, sterilisation and process validation
- Vigilance, GMP, marketing authorisation and supplier audits
Experience
Esra Gündağ has worked in management roles in the quality departments of medical device manufacturers. That work covered setting up and maintaining quality management systems, notified body and certification audits, design files and post-market processes.
The same measure carries into consultancy. A technical file should not be built merely to pass an audit; it has to carry the product for years. A procedure has to be lean enough for the team that will actually use it.
The products involved range from sterile single-use devices to drug-device products. Where a device contains a medicinal substance, device and medicinal requirements have to be handled together — that is a distinctive part of this experience.
Who it is for
EUmediq supports manufacturers in Türkiye that place devices on the European market, or are preparing to. Start-ups entering their first CE process, established manufacturers moving from MDD to MDR, companies developing drug-device products and contract manufacturing sites are all part of that group.
If you have a quality and regulatory function, EUmediq shares its load. If you do not, it helps you build one your team can run on its own.
How the work is organised
EUmediq works in two ways. In project work the scope and deliverables are defined up front: adapting a technical file to the MDR, writing a clinical evaluation report, or preparing for an ISO 13485 certification audit.
In ongoing consultancy EUmediq acts as the external support of your quality and regulatory function. Internal audits, management reviews, PMS reports and PSUR updates are put on a calendar, and correspondence with the notified body is followed regularly.
Either way the process starts with a short introductory call; sending your request through the contact form is enough. Before that call it is enough to know your device, its class and your target market. If you ask for a non-disclosure agreement, it is signed before any document is shared. Documents are prepared in Turkish or English as needed.
Consultancy does not end when a document is delivered. Every document is reviewed together with your team. It is your team that will answer the auditor’s questions, so it needs to know the reasoning behind the document.
