Skip to content

I

MDR 2017/745 TECHNICAL DOCUMENTATION REQUIREMENTS FOR THE ORTHOPEDIC INDUSTRY

SPECIALISED WEBINAR

May 13, 2026

SAVE THE DATE

13th of May, 2026

SPECIALISED WEBINAR for

MDR 2017/745 TECHNICAL DOCUMENTATION REQUIREMENTS FOR THE ORTHOPEDIC INDUSTRY

This webinar is specifically designed for Legal Manufacturers of Orthopaedic Implants and reusable surgical instruments. A brief introduction on current status and MDR conformity assessment process in TÜV Nord, will be followed by an one-hour presentation inspired by field discussions and concerns of the Orthopaedic Industry. The webinar will cover MDR Technical Documentation requirements and offer participants a valuable insight into all pertinent aspects. The agenda will be followed by a constructive Q&A session which will further facilitate understanding and take-home messages.

 

MDR topics will cover:

  • Design, Manufacture & Risk Management
  • Technical Docs & QMS prep
  • QMS & Procedures related topics
  • UDI aspects, Labels and IfUs
  • Subcontractors & suppliers
  • Usability engineering & assessment
  • Clinical Evaluation, incl. PMCF

  • PMS actions and Incident reporting

     

Othopaedic Medical Devices for:

  • Joint Reconstruction / arthroplasty
  • Spinal surgery / fusion / scoliotic management
  • Internal fixation plating and screws
  • Intramedullary fracture management
  • Sports injuries and ligament reconstruction
  • Biomaterials (alloys, ceramic and polymers)
  • Coatings, grafts and sutures

  • Pediatric orthopaedics

     

Agenda

  • Welcome note and Introduction on Medical Devices in TÜV Nord/Conformity Assessment Process

Ms. Tarsi Giannouli

Vice President Medical Devices/Health at TÜV Nord Hellas

(20 min)

 

  • Welcome note for Egyptian and Turkish Manufacturers

Dr. Omar Hussain/Head of Medical Devices at TÜV Nord Egypt and Dr.Fulya ÖZMEN/Medical Product Manager

TÜV Nord Turkey

(10min)

 

  • ORTHOPAEDIC INDUSTRY MDR obligations for Technical Documentation

Dr Evangelos Magnisalis

BiomedEng PhD, MDR Expert & Lead Auditor at TÜV Nord Cert

(60 min)

 

  • Q&As

(30 min)

Στοιχεία Επικοινωνίας