References

Ontex Tüketim Ürünleri San. ve Tic. A.Ş (CANBEBE)
  • Adult Diapers

  • ISO 13485 Quality Management System Consulting
  • Technical File Consulting

Vem İlaç San. ve Tic. A.Ş
  • Isotonic Nose and Eye Solutions

  • ISO 13485 Standard Informational Training
  • Clinical Evaluation Training
  • Technical File Construction Training

SÜMER ULUSLARARASI SANAYİ VE TİCARET A.Ş
  • Isotonic Nose and Eye Solutions
  • ISO 13485 Quality Management System Consulting
  • Technical File Consulting
  • Composing Meddev 2.7.1 Clinical Evaluation File

DLR MEDİKAL SAN. VE DIS. TİC. LTD. ŞTİ.
  • Central Venous Catheter, Long and Short Term Hemodialysis Catheters, Mesh, Urology Catheter and Sets
  • ISO 13485 Quality Management System Consulting
  • Technical File Consulting
  • ETO Sterilization Validation
  • Ultrasonic Cleaner Validation
  • Meddev 2.7.1 Clinical Evaluation File Construction

DEVA TIBBİ MALZEMELER SAN. TİC. LTD. ŞTİ.
  • Orthopedic and Trauma Plates
  • ISO 13485 Quality Management System Consulting
  • Technical File Consulting
  • Vapor Autoclave Sterilization Validation
  • Ultrasonic Cleaner Validation
  • Meddev 2.7.1 Clinical Evaluation File Construction

TRİOS SAĞLIK VE MEDİKAL TEKNOLOJİLERİ SANAYİ TİCARET ANONİM ŞİRKETİ
  • Dental Implant Systems
  • ISO 13485 Quality Management System Consulting
  • Technical File Consulting
  • ETO Sterilization Validation
  • Ultrasonic Cleaner Validation
  • Meddev 2.7.1 Clinical Evaluation File Construction

İstanbul Travma Tıbbı Malzeme Sanayi Ticaret Limitet Şirketi
  • Orthopedic and Trauma Plates
  • ISO 13485 Quality Management System Consulting
  • Technical File Consulting
  • Vapor Autoclave Sterilization Validation
  • Ultrasonic Cleaner Validation
  • Meddev 2.7.1 Clinical Evaluation File Construction

ANKA SAĞLIK GEREÇLERİ SAN. İÇ VE DIŞ TİC. LTD. ŞTİ.
  • Ligation Clips, Ecarteurs, Tissue and Organ Removal Bags
  • ISO 13485 Quality Management System Consulting
  • Technical File Consulting
  • Meddev 2.7.1 Clinical Evaluation File Construction

TRUEMED MEDİKAL ÜRÜNLER ÜRETİM VE PAZARLAMA A.Ş
  • Orthopedic and Trauma Plates, Screws and Intramedullar Nails
  • ISO 13485 Quality Management System Consulting
  • Technical File Consulting
  • Vapor Autoclave Sterilization Validation
  • Ultrasonic Cleaner Validation
  • Meddev 2.7.1 Clinical Evaluation File Construction

Aero Medikal Sağlık Turizmi Tıbbi Ürünler ve İthalat İhracat Sanayi Tic. Ltd. Şti
  • Spinal Implants (Screw, Disc, Prothesis, Cage Systems)
  • ISO 13485 Quality Management System Consulting
  • Technical File Consulting

Medical Consept Sağlık Turizm San. Tic. Ltd. Şti.
  • Spinal Implants (Screw, Disc, Prothesis, Cage Systems)
  • ISO 13485 Quality Management System Consulting
  • Technical File Consulting

Ceren Otomat Metal İşleme San. ve Tic. LTD. ŞTİ
  • Dental and Orthopedic Drills
  • ISO 13485 Quality Management System Consulting
  • Technical File Consulting
  • Vapor Autoclave Sterilization Validation
  • Ultrasonic Cleaner Validation
  • Meddev 2.7.1 Clinical Evaluation File Construction

Optimas Medikal Ürünler Sanayi ve Tic.Ltd.Şti.
  • IVF Micropipettes
  • ISO 13485 Quality Management System Consulting
  • Technical File Consulting
  • Gamma Sterilization Validation
  • Meddev 2.7.1 Clinical Evaluation File Construction

GEMED SAĞLIK ÜRÜNLERİ SAN. VE TİC.LTD.ŞTİ
  • Anesthesia, Cardiology, Oncology, General Surgical Consumables (Catheter Sets, Introducer Sets, Guide Wires)
  • ISO 13485 Quality Management System Consulting
  • Technical File Consulting

Medikokim Tıbbi Kimyevi Malzeme San.Tic.Ltd.Şti
  • Brain Pads and Disposable Consumables
  • Brain Pads and Disposable Consumables
  • Technical File Consulting
  • Gamma Sterilization Validation
  • Meddev 2.7.1 Clinical Evaluation File Construction

Palmed Sağlık Ürünleri San. ve Tic. Ltd. Şti.
  • PRP Kits
  • ISO 13485 Quality Management System Consulting
  • Technical File Consulting
  • Meddev 2.7.1 Clinical Evaluation File Construction

Er Tıbbi Ürünler Sağlık Hizmetleri Pazarlama ve Dış Tic. Ltd. Şti.
  • Hair Transplantation Needles (Fue Punch)
  • ISO 13485 Quality Management System Consulting
  • Technical File Consulting
  • Vapor Autoclave Sterilization Validation
  • Ultrasonic Cleaner Validation
  • Meddev 2.7.1 Clinical Evaluation File Construction

GAMA ARAŞTIRMA PATENT TASARIM VE ENDÜSTRİYEL ÜRÜNLER SANAYİ TİCARET LTD ŞTİ.
  • Nebulizer Devices and Accessories
  • ISO 13485 Quality Management System Consulting
  • Technical File Consulting
  • Meddev 2.7.1 Clinical Evaluation File Construction

Diartek Dijital Tıbbi Cihazlar AR – GE Teknolojileri Sanayi ve Tic. Ltd. Şti.
  • Digital Screening (Roentgen) Systems
  • ISO 13485 Quality Management System Consulting
  • Technical File Consulting
  • Meddev 2.7.1 Clinical Evaluation File Construction

Detroks Kimya ve Sağlık Ürünleri Ürt. Dağ. Hizm. San İç ve Dış Tic. Ltd. Şti.
  • Disinfectants
  • ISO 13485 Quality Management System Consulting
  • Technical File Consulting

Ünsal Plastik Ambalaj San. Ve Tic. Ltd. Şti.
  • Syrup Spoons
  • ISO 13485 Quality Management System Consulting
  • Technical File Consulting
  • Meddev 2.7.1 Clinical Evaluation File Construction

D.R.S. AYAKKABI TABANI VE YAN SAN. LTD. ŞTİ.
  • Orthopedic Shoes
  • ISO 13485 Quality Management System Consulting
  • Technical File Consulting
  • Meddev 2.7.1 Clinical Evaluation File Construction

DEHAS Medikal Gaz Teknik Ltd. Şti.
  • Medical Gas Systems (Flowmeter, Gas Sockets, Patient Bedside Units, Intensive Care Units, Medical Gas Plants)
  • ISO 13485 Quality Management System Consulting
  • Technical File Consulting
  • Meddev 2.7.1 Clinical Evaluation File Construction

Özcan Kardeşler Tıp Cihazları Sanayi ve Ticaret Ltd. Şti.
  • Medical Gas Systems (Flowmeter, Gas Sockets, Patient Bedside Units, Intensive Care Units, Medical Gas Plants)
  • ISO 13485 Quality Management System Consulting
  • Technical File Consulting
  • Meddev 2.7.1 Clinical Evaluation File Construction

FG GRUP SAĞLIK İNŞ. HAR. MİM. MÜH. ELEKT. SAN. VE TİC. A.Ş
  • Embolization and Surgical Adhesives, Laser Ablation Set Groups, DVT Products
  • ISO 13485 Quality Management System Consulting
  • Technical File Consulting
  • ETO Sterilization Validation
  • Ultrasonic Cleaner Validation
  • Aseptic Filling Validation
Turk İlaç Ve Serum Sanayi A.Ş
  • Hemodialysis Solutions
  • Hemofiltration Solutions
  • ISO 13485 Quality Management System Consulting
  • Technical File Consulting
Betatech Medikal Cihazları San. Mümessillik İç Ve Dış Tic. Ltd. Şti.
  • Adhesion Barrier Gel
  • Absorbable Hemostat (ORC)
  • Partially Absorbable Composite Meshes
  • Surgical Brain Pads
  • Surgical Polypropylene Meshes
  • Double Sided Surgical Meshes

 

  • ISO 13485 Quality Management System Consulting
  • Technical File Consulting
  • Meddev 2.7.1 Clinical Evaluation File Construction
  • Ultrasonic Cleaner Validation
  • Packaging Validation
  • Ethylene Oxide Sterilization Validation
  • Gamma Sterilization Validation
Ece Tıbbi Cihazlar Ve Medikal San. Tic. A.Ş
  • Nebulizers
  • CPAP and BPAP Masks
  • ISO 13485 Quality Management System Consulting
  • Technical File Consulting
Komed Medikal Sağlık Tic. Ltd. Şti.
  • Respiratory Function Test Filters
  • ISO 13485 Quality Management System Consulting
  • Technical File Consulting
Formed Sağlık Eğitim Sosyal Hizmetler Tıbbi Ve Kozmetik Ürünler Sanayi Ve Ticaret Ltd. Şti.
  • Orthopedic Shoes
  • ISO 13485 Quality Management System Consulting
  • Technical File Consulting
Biopark Medikal Sanayi Ve Ticaret Anonim Şirketi
  • Mesotherapy Guns
  • Mesotherapy Needles
  • ISO 13485 Quality Management System Consulting
  • Technical File Consulting
  • Meddev 2.7.1 Clinical Evaluation File Construction
  • Ultrasonic Cleaner Validation
Meka Endüstriyel Tasarım Kalıp Medikal İmalat San. Tic. Ltd. Şti.
  • Nonsterile Oxygen Mask
  • Nonsterile Nebulizer Set
  • Nonsterile Nasal Oxygen Canulla
  • Nonsterile Urine Bag
  • ISO 13485 Quality Management System Consulting
  • Technical File Consulting
  • Meddev 2.7.1 Clinical Evaluation File Construction
Kc Med Medikal Sağlık Hiz. İthalat İhracat A.Ş
  • Suture Screwed Anchor with Needles
  • Tenacious Interference Screw
  • U Nails
  • Double Buttoned Connector/Tendon/Tissue Repair Systems
  • Fermobutton Femoral Suspender Systems
  • Femoral Cortical suspender Systems
  • Femopin Cannulated Guide Wire Sets
  • Guide Wires
  • Plastic Cannulas
  • Arthroscopic Razor Blades
  • Meniscus Sutures
  • Suture Carriers
  • ISO 13485 Quality Management System Consulting
  • Technical File Consulting
  • Meddev 2.7.1 Clinical Evaluation File Construction
Barotek Tıbbi Malz. Medikal Ürünler Sualtı Dalış Ekip. San. Ve Tic. Ltd. Şti.
  • Hyperbaric Oxygen Room
  • ISO 13485 Quality Management System Consulting
  • Technical File Consulting
  • Meddev 2.7.1 Clinical Evaluation File Construction
StemC Biyoteknoloji A.Ş
  • Mechanic Fat Tissue Breaking Filtration Device and Accessories
  • ISO 13485 Quality Management System Consulting
  • Technical File Consulting
  • Meddev 2.7.1 Clinical Evaluation File Construction
  • Ultrasonic Cleaner Validation
  • Packaging Validation
  • Gamma Sterilization Validation
4XB Medikal Teknolojileri İmalat AR – GE Tasarım Danışmanlık İthalat İhracat San. Ve Tic. Ltd. Şti.
  • Periton Dialysis Device
  • ISO 13485 Quality Management System Consulting
  • Technical File Consulting
  • Meddev 2.7.1 Clinical Evaluation File Construction
DMC MEDİKAL
  • Silver Dressed Wound Care Sponge Set
  • Wound Care Ser Sponges and Collecting Contianer
  • ISO 13485 Quality Management System Consulting
  • Technical File Consulting
  • Meddev 2.7.1 Clinical Evaluation File Construction
Maviay Medikal Sanayi ve Ticaret Limited Şirketi
  • Nasal Oxygen Cannula
  • Nebulizer Set Cannula
  • Oxygen Mask Cannula
  • ISO 13485 Quality Management System Consulting
  • Technical File Consulting
  • Meddev 2.7.1 Clinical Evaluation File Construction
YÜ – CE Tıbbi Gereçler İthalat İhracat Mümessillik San. Tic. Ltd. Şti.
  • Synthetic Absorbable Surgical Sutures
  • Synthetic Nonabsorbable Surgical Sutures
  • Radiopaque and non-radiopaque Surgical Gauze Patch
  • Sterile disposable Surgical Cloth and Aprons
  • ISO 13485 Quality Management System Consulting
  • Technical File Consulting
  • Meddev 2.7.1 Clinical Evaluation File Construction
Vamet Medikal Sağlık Ürünleri ve Hizmetleri İthalat İhracat San. Ve Tic. A.Ş.
  • ISO 13485 Quality Management System Consulting
  • Technical File Consulting
  • Meddev 2.7.1 Clinical Evaluation File Construction
  • Ultrasonic Cleaner Validation
Ivf Prime Sağlık Ürünleri San. Ve Tic. A.Ş.
  • Medical device disinfectants
  • ISO 13485 Quality Management System Consulting
  • Technical File Consulting
  • Meddev 2.7.1 Clinical Evaluation File Construction
YNK Medikal Mekanik Elektronik San. Ve Tic. Ltd. Şti.
  • Dental Implants
  • ISO 13485 Quality Management System Consulting
  • Technical File Consulting
  • Meddev 2.7.1 Clinical Evaluation File Construction
  • Vapor Autoclave Validation
Vida Dental Sanayi ve Ticaret Limited Şirketi
  • Dental Implants
  • Dental Implants
  • ISO 13485 Quality Management System Consulting
  • Technical File Consulting
  • Meddev 2.7.1 Clinical Evaluation File Construction
  • Vapor Autoclave Validation
Kılıç Med Medikal Sanayi İç ve Dış Ticaret Ltd. Şti.
  • Disposable and Reusable Resuscitator Systems
  • ISO 13485 Quality Management System Consulting
  • Technical File Consulting
  • Meddev 2.7.1 Clinical Evaluation File Construction
Labcera Seramik San. Tic. Ltd. Şti.
  • Dental Zirconia Block
  • ISO 13485 Quality Management System Consulting
  • Technical File Consulting
  • Meddev 2.7.1 Clinical Evaluation File Construction
Edin Medikal Tıbbi Cihazlar Üretim Teknolojileri A.Ş.
  • Aspiration Bag Set
  • Oxygen Mask Set
  • Yankauer Aspiration Sat
  • ISO 13485 Quality Management System Consulting
Piyon İç ve Dış Pazarlama Gıda San. Tic. Ltd. Şti.
  • Breast Milk Storing and Preservation Kits
  • ISO 13485 Quality Management System Consulting
  • Technical File Consulting
  • Meddev 2.7.1 Clinical Evaluation File Construction
U&I CORPORATİON
  • Absorbable Magnesium Screws, Pins and K-wires (Second Manufacturer around the world)
  • Technical File Construction
  • ISO 13485 Quality Management System Establishment

HUAIAN PINGAN MEDICAL INSTRUMENT CO. LTD.
  • Non Absorbable Sutures
  • Technical File Construction
  • ISO 13485 Quality Management System Establishment
DONGGUAN EONTEC CO. LTD.
  • Absorbable Magnesium Screws
  • (Third Manufacturer around the world)
  • Technical File Construction
  • ISO 13485 Quality Management System Establishment
ENDO(HANGZHOU)MEDICAL TECHNOLOGY CO.LTD
  • Power Shaver System
  • Technical File Construction
  • ISO 13485 Quality Management System Establishment
SHANGHAI MICROPORT ENDOVASCULAR MEDTECH CO.,LTD.
  • Abdominal Aortic Stent – Graft and Delivery System,
  • Drug Coated Balloon PTA Catheher
  • Clinical Evaluation Report Establishment
  • Post Market Surveillance Report Establishment
WU HAN DRAGONBIO ORTHOPEDIC PRODUCTS CO.,LTD
  • Hip Prosthesis
  • Clinical Evaluation Report Establishment
  • Post Market Surveillance Report Establishment
PISHRO TASHKHIS FARDAVAR
  • Blood Bags
  • Technical File Construction
  • ISO 13485 Quality Management System Establishment
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