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.
450+
Certified Medical Device
150+
Counseling Company
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
- Absorbable Orthopedic Implants
- Dental Implants
- Dental and Orthopedic Burs, Drillers
- Spinal (Vertebra) Implants
- Sterile – Nonsterile Consumables
- Absorbable and Non-Absorbable Sutures
- Brain Pads
- Wound Care Products
- Silver and Non-Silver Wound Care Sponges
- Absorbable Tissue and Surgical Adhesives
- DVT (Deep Vein Thrombosis) Sets
- Laser Ablation Set Groups
- PRP (Platelet Rich Plasma) Kits
- Fue Punch (Hair Transplant Needles)
- Breathing Circuits
- Surgical Masks
- Ventilators
- Digital X-Ray Equipment
- Autoclave Sterilizers
- Hyperbaric Oxygen Cabinets
- Medical Device Disinfectants
- Hemodialysis Solutions
- Isotonic Nose and Eye Solutions
- Surgical Aprons
- Syrup Scales and Spoons
- Orthotics – Prostheses
- Hospital Bed Linens
- Medical Gas Systems
- Oxygen Plants
- Breathing Filters
- Resuscitator (Ambu) Sets
- Mesotherapy Application Gun and Sets
- Injectors
- IVF Micropipettes
- Dental Zircon Block
- Mechanical Fat Tissue Shredding and Filtering Devices
- Drug Coated Balloon Stent
- Blood Bag
- Electrocauteries
- Lubricating Gels
- Bone Cement and Grafts
- Cryogenic Cartridges