MEDICAL DEVICE QUALITY ASSURANCE TRAINING AND CONSULTANCY SERVICES

Our main objective is to provide the knowledge our clients need to ensure the quality assurance of medical devices. We provide professional consulting services for organizations involved in the life cycle of medical devices. Within the scope of our activities, we provide consultancy services on the establishment of quality management system in accordance with ISO 13485 standard, preparation for control and certification inspections, completion of preparations for CE certification inspections of medical devices in accordance with European Union medical device legislation, training and infrastructure and process validations.
Detailed information: www.esratatli.com

TIBBİ CİHAZLAR KALİTE GÜVENCE EĞİTİM VE DANIŞMANLIK HİZMETLERİ

Temel amacımız, danışanlarımızın tıbbi cihazların kalite güvencesinin sağlanabilmesi ile ilgili olarak ihtiyaç duydukları bilgiyi sağlamaktır.
Tıbbi cihazların yaşam çevrimi boyunca rol alan kuruluşlar için profesyonel danışmanlık hizmeti vermekteyiz. Yürüttüğümüz faaliyetler kapsamında ISO 13485 standardına uygun olarak kalite yönetim sisteminin kurulması, kontrolü ve belgelendirme denetimlerine hazırlık, tıbbi cihazların Avrupa Birliği tıbbi cihaz mevzuatına uygun olarak CE belgelendirme denetimlerine hazırlıkların tamamlanması, eğitimler ve altyapı ve süreç validasyonları konularında danışmanlık hizmeti bulunmaktadır. Detaylı bilgi için: www.esratatli.com

Izmir, Turkey

- As the head of the quality department, working with a team of five to supervise the quality management system, regulatory affairs, CE certification and quality control.
- Establishment and implementation of ISO 13485:2016 Quality Management System for Medical Devices, integrating a risk-based approach to all processes and implementation of EN ISO 14971:2012 in the quality system, deployment and executing QDMS software to follow the company's quality management system.
- Performing the duties of the Quality Management Representative specified in ISO 13485:2016 standard, including;
o Control of compliance with regulatory requirements and monitoring legislative changes
o Data analysis and prepreation of management review meeting inputs
o Documentation control
o Planning and executing internal audits
o Monitoring of corrective and preventive activities
o Monitoring of customer feedback
- Establishment and execution of post-market surveillance processes
- Control and management of technical files. Product groups include:
o Infusion Group
* IV Flow Controller (Controflow) – Class IIa
* Extension Line – Class IIa
* Pressure Line – Class IIa
* Photosensitivity Extension Line – Class IIa
o Gynecology Products
* Karman Cannula – Class IIa
* Karman Cannula Injector – Class IIa
* Cervix Brush – Class Is
* Pouch Perforator – Class Is
* Umbilical Cord Clamp – Class Is
o Surgical Drapes
* C-Arm Drapes – Class Is
* Fluoroscopy Drape – Class Is
* Scopy Drape – Class Is
* Video Camera Covers – Class Is
* Microscope Drape – Class Is
* Universal Light Handle Cover – Class Is
o Endoscopy
* Endoscopy Mouthpiece – Class Is
o Surgical Products
* Mucous Aspirator – Class IIa
* Arthroscopy Set – Class IIa
* Impregnated Surgical Hand Brush
* Dry Sterile Surgical Hand Brush
o Others
* Phototherapy Eye Band – Class Is
* Limb Holder – Class Is
* Valve Urine Bag with Discharger – Class Im
* Valve Emesis Bag – Class Im
* Skin Marking Set – Class IIa
* Spirometer Filter – Class IIa
- Planning of the transition process to (EU) 2017/745 Medical Devices Regulation
- To follow up special processes (ethylene oxide sterilization, packaging, clean room infrastructure) and realize them in accordance with special standards.

Izmir, Turkey

- Implementing the audits carried out according to ISO 13485 QMS and MDD 93/42/EEC

Istanbul, Turkey

- Establishment and implementation of ISO 13485: 2003 Quality Management System for Medical Devices and ISO 9001: 2008 Quality Management System
- Fulfillment of the duties of Quality Management Representative stated in ISO 13485:2003
o Check compliance with regulatory requirements and monitor legislative changes
o Documentation control
o Planning and conducting internal audits
o Monitoring of corrective and preventive activities
o Monitoring customer feedback
- Preparation of technical and design dossiers (classification, technical drawings in AutoCAD software, risk management documentation according to ISO 14971, clinical data assessment, biocompatibility data assessment according to ISO 10993-1 and CE certification according to Directive 93/42/EC of medical devices) . Product groups included:
* Vein valves and infusion sets (Class IIa)
* Endovenous Laser Application Sets (Class IIa)
* Cardiology Group (torquer, extension line, insertion tool, stopcocks, manifolds, pressure extension lines, inflation device (indeflator), guide wire (Class III, Class IIa, Class Is)
* Cardiovascular Surgery (Extracorporeal Bypass Sets) (Class IIa)
* Surgical Drape - Gown Sets (Class Is)
- Planning and conducting process and infrastructure validations, including testing
o Cleanroom validation according to ISO 14644 standards
o Validation of Ethylene Oxide Sterilization according to ISO 11135-1 / 2
o Validation of the packaging process according to ISO 11607-1 / 2

Antalya, Turkey

Establishing and performing an integrated Quality Management System including ISO 9001, ISO 22000, ISO 14001 and ISO 18001

- Quality documentation
- Risk management (food related, occupational and environmental)
- Internal audits
- Supplier audits
- Follow-up customer complaints
- Follow-up of corrective and preventive actions

Antalya, Turkey