We would like to be the solution partner of Medical Device manufacturers, by providing guidance in QUALITY, REGULATORY & CLINICAL affairs, organizing technical trainings, and proven advices for MDR & IVDR compliance.
Our goal as a consultancy company is to be a one-stop-shop to provide a wide range of services to medical & IV diagnostic device manufacturers regarding ISO 13485 Quality Management Systems, MDR & IVDR documents such as STED, Usability, PMS, PSUR, CER, PMCF, SSCP and also Clinical trials.
If you need a trusted , reliable and affordable consultancy, you are on the right page.
With our expert teams who have deep know-how in quality and regulatory, you are going to save time and increase your operational efficiency.
Please do check our references from our web site.
Company Details
- Employees
- 9
- Founded
- -
- Address
- Mevlana Mah. Yıldırım Beyazit Cad. Ataelisitesi No:23 Daire:8 Esenyurt, Istanbul,other European Countries 34515,turkey
- Industry
- Medical Equipment Manufacturing
- NAICS
-
Medical Equipment and Supplies ManufacturingSurgical and Medical Instrument ManufacturingSurgical Appliance and Supplies ManufacturingDental Equipment and Supplies ManufacturingOphthalmic Goods ManufacturingDental Laboratories
- Website
- adviqual.com.tr
- Keywords
- Klinik veri değerlendirme, meddev 2.7.1, süreç validasyonu, Kalite yönetim sistemi, ISO 13485, 17025, 14971, tıbbi cihaz Risk Yönetimi, Biyouyumluluk, sterilizasyon validasyonu, gap analizi, teknik dosya, tıbbi cihaz kalite danışmanlığı, FDA başvuru, biyouyumluluk değerlendirme, CE sertifikasyon, medikal cihaz ARGE, tıbbi cihaz tasarım, medikal cihaz kalite yönetimi, MDR, MEDDEV 2.7.1, medical device quality management consulting, medical device clinic evaluation, process validation, ISO 13485:2016, ISO 14791, ISO 17025, ISO 10993, regulatory compliancy, CE certification, medical device technical dossier, medical device biocompatibale evaluation, medical device risk analysis, Mock Audit, GAP Audit, Risk management, medikal cihaz risk analiz, risk yönetimi, tıbbi cihaz için teknik eğitimler, medikal cihaz eğitim, PMS, PMCF, Satış sonrası izleme, yazılım validasyonu, ruhsatlandırma, satış kaydı, FDA submission, GMP, GLP, internal audit, FMEA, CAPA, EO sterilizasyon, Steam sterilization, EO ve Buhar sterilizasyon, validasyon, validation, risk analiz raporu, teknik dosya hazırlama, tıbbi cihaz danışman, medical device techinal reports, medical device report preparation, MDR, ISO 11135, ISO 11137, ISO 14971, EU 2017/745, EU 2017/746, IVDR, MDR teknik dosya, tıbbi cihaz, Tıbbi cihaz CE sertifikası, QMS, CE certification of invitro diagnostic devices, MDR technical file, MDR technical dossier, supplier audit, GAP audit, mock audit, GMP Audit, software validation, CSV, MDR compliance.
- HQ
- Istanbul, Other European countries
Adviqual Questions
Adviqual's website is adviqual.com.tr
Adviqual's LinkedIn profile is https://tr.linkedin.com/company/adviqual
Adviqual has
9 employees.
View email and phone details for 9
employees at Adviqual.
Adviqual's industry is
Medical Equipment Manufacturing
Adviqual's categories are Medical Equipment Manufacturing
Adviqual's founding year is 2015
