About Us

TıbbiCE Consulting, Training and Validation Services

TıbbiCE Consulting, Training and Validation Services, offers consulting, training and validation services to domestic and overseas medical device producers during their CE and ISO 13485 Certification (93/42/EEC) process. With its expert staff from different backgrounds including but not limited to biology and biomedical, mechanical and metallurgy engineering, TıbbiCE Consulting, Training and Validation Services is the medical device consulting company with the largest expert staff in Turkey.

TıbbiCE Consulting, Training and Validation Services’ principle for product and quality management system is to give a “Purpose-driven, Solution and Customer Satisfaction Oriented” service that grounds on data confidentiality with its expert consultants.
We share the knowledge and experience we have gained in 9 years through working with more than 140 medical device producers and being involved in the CE and ISO 13485 Certification processes of more than 300 medical devices. We conduct the certification process professionally and aim to complete it in optimum time.

Gökhan YALÇIN

Consulting Services;

  • ISO 13485 Certification Consulting
  • 93/42 EEC CE Certification Consulting
  • Clinical Evaluation Studies According to Meddev 2.7.1 Guidelines
  • ISO 14971 Risk Analysis Studies
  • Post Marketing Follow-up Studies According to Meddev 2.12.1 and Meddev 2.12.2 Guidelines

Validation Services;

  • Ethylene Oxide Sterilization Validation
  • Gamma Sterilization Validation
  • Autoclave Sterilization Validation
  • Ultrasonic Cleaner Validation
  • Packaging Process Validation
  • Product Shelf-life Validation

Training Services;

  • ISO 13485 General Informational, Documentation and Internal Audit Training
  • 93/42 EEC Guide Informational Training
  • Technical File Preparation Training
  • Meddev 2.7.1 Clinical Evaluation Training
  • ISO 14971 Risk Analysis Training
  • Meddev 2.12.1 and Meddev 2.12.2 Post Marketing Follow-up Studies Training
  • Design and Development Training
Product groups that we have worked with for certification purposes;
  • Orthopedics and trauma implants (plates, screws, intramedullar nails, external fixators, cerclage cables, kirschner wires)
  • Arthroscopy Implants
  • Absorbable Orthopedic Implants (Screws, Pins, Kirschner Wires)
  • Dental Implants (Implant, Abutment, Screws)
  • Dental and Orthopedic Drills
  • Spinal (Vertebral) Implants (Disc Prosthesis, Cage Systems, Spinal Nails, Rod and Connective Pieces)
  • Sterile-Non Sterile Angiography, Anesthesia, Cardiology, Oncology, Urology, Laparoscopy, General Surgical Consumables (Catheter Sets, Nonabsorbable Meshes, Guidewire, Dilator, Introducer Set Products, Needles, Syringes, Infusion Sets, Ligation Clips)
  • Absorbable and Nonabsorbable Sutures
  • Brain Pads
  • Wound Care Products (Gauze Bandage, Wound Tampon Products)
  • Silver Dressed and Undressed Wound Care Sponges
  • Absorbable Tissue and Surgical Adhesives
  • DVT (Deep Venous Thrombosis) Sets
  • Laser Ablation Set Groups
  • Respiration Filtration
  • Resuscitator (Ambu) Sets
  • IVF Micropipettes
  • Hypodermic Syringes
  • PRP (Platelet Rich Plasma-Platelet) Kits
  • Fue Punch(Hair Transplantation Needles
  • Ventilation Circuits (Masks, Extension Circuits)
  • Digital Roentgen Devices
  • Ventilation Devices (CPAP, BPAP Devices)
  • Autoclave Sterilizer
  • Medical Device Disinfectants
  • Hemodialysis Solutions
  • İsotonic Nose and Eye Solutions
  • Disposable Sterile – Nonsterile Cloth Aprons
  • Syrup Scales and Spoons
  • Orthopedic Shoes
  • Orthesis – Prothesis
  • Patient Bed Cloths
  • Medical Gas Systems (Bedside Monitoring and Intensive Care Units, Pendants, Medical Gas Plants, Flowmeters, Regulators, Alarm Units, Medical Gas Sockets and Probes)
  • Oxygen Centrals
  • Breast Milk Storing and Preservation Kits
  • Mesotherapy Guns and Needles
  • Nebulizer Devices and Accessories
  • Stromal Vascular Fracture Systems
  • Blood bags
  • Electrocautery

REFERENCES

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