Hakkımızda

Megacert Hakkında

Megacert, tıbbi ve in vitro tanı (IVD) cihaz üreticilerine yönelik CE, FDA ve ISO 13485 belgelendirme süreçlerinde uzmanlaşmış, uluslararası düzeyde hizmet veren bir teknik danışmanlık firmasıdır.

MDR (2017/745) ve IVDR (2017/746) kapsamında teknik dosya hazırlığı, kalite yönetim sistemi kurulumu, validasyon süreçleri ve onaylanmış kuruluşlarla denetim koordinasyonu başta olmak üzere, belgelendirme sürecinin tüm aşamalarında üreticilerin yanındayız.

A medical examination room featuring an examination table covered with a white paper sheet. Medical instruments such as a blood pressure gauge, otoscope, and ophthalmoscope are mounted on the wall. The furnishings include light-colored walls and cabinets.
A medical examination room featuring an examination table covered with a white paper sheet. Medical instruments such as a blood pressure gauge, otoscope, and ophthalmoscope are mounted on the wall. The furnishings include light-colored walls and cabinets.
İletişim
A group of medical professionals and possibly officials are gathered around a patient in a hospital ward. The patient is seated on a hospital bed, engaging with the people around him. Several men in uniform and plain clothes are present, suggesting a formal visit or inspection.
A group of medical professionals and possibly officials are gathered around a patient in a hospital ward. The patient is seated on a hospital bed, engaging with the people around him. Several men in uniform and plain clothes are present, suggesting a formal visit or inspection.
A healthcare professional wearing a white coat and a green face mask is standing at a counter or a pharmacy. They are focused on a piece of paper or prescription pad. Behind them, several people are waiting in line, suggesting a public or clinical setting. Various medical supplies and garments are visible around the area.
A healthcare professional wearing a white coat and a green face mask is standing at a counter or a pharmacy. They are focused on a piece of paper or prescription pad. Behind them, several people are waiting in line, suggesting a public or clinical setting. Various medical supplies and garments are visible around the area.

Biz Kimiz

300'ün üzerinde ürün deneyimi ve %100 tıbbi cihaz odaklı hizmet yaklaşımımızla, üreticilerin denetimlere eksiksiz hazırlanmasını sağlıyor; süreci mevzuata tam uyumlu ve stratejik bir şekilde yönetiyoruz.

Online toplantı ile nasıl destek olabileceğimizi dinlemek isterseniz, her zaman iletişime geçebilirsiniz.

A medical professional wearing protective gear and magnifying glasses is performing a procedure. The setting is brightly lit, highlighting the focus on the detailed work being done. Instruments and gloved hands are visible, indicating a clinical environment.
A medical professional wearing protective gear and magnifying glasses is performing a procedure. The setting is brightly lit, highlighting the focus on the detailed work being done. Instruments and gloved hands are visible, indicating a clinical environment.

Galeri

MDR konusunda uzmanlık ve kaliteli hizmet sunuyoruz.

A person wearing full protective medical gear and a face shield is holding a clipboard and pen in a tent-like environment. Various equipment and items are scattered on tables in the background.
A person wearing full protective medical gear and a face shield is holding a clipboard and pen in a tent-like environment. Various equipment and items are scattered on tables in the background.
A person wearing a mask receives a vaccination from a healthcare professional, also wearing a mask, in a medical office setting. The professional is dressed in a white coat, indicating a clinical environment. Documented information is visible in the background on the walls.
A person wearing a mask receives a vaccination from a healthcare professional, also wearing a mask, in a medical office setting. The professional is dressed in a white coat, indicating a clinical environment. Documented information is visible in the background on the walls.

Megacert, MDR konusundaki profesyonel hizmetleriyle süreçlerimizi büyük ölçüde kolaylaştırdı. Teşekkürler!

Selçuk Kural

A person in a lab coat stands beside a patient who is lying down on a table that is part of a large medical imaging machine. The setting appears to be a clean and modern medical facility.
A person in a lab coat stands beside a patient who is lying down on a table that is part of a large medical imaging machine. The setting appears to be a clean and modern medical facility.
A medical imaging device with a monitor displaying a user interface featuring multiple icons and buttons. The device is labeled 3D OCT Maestro by Topcon. There is also a black adjustable arm and other medical supplies in the background.
A medical imaging device with a monitor displaying a user interface featuring multiple icons and buttons. The device is labeled 3D OCT Maestro by Topcon. There is also a black adjustable arm and other medical supplies in the background.

★★★★★

Hizmetler

MDR konusunda teknik danışmanlık ve destek sağlıyoruz.

İLETİŞİM

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