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BIZLINK Robotic Solutions

Manufacturer
Orthopaedic Surgery & Implants
Audit
  • ISO 13485 Internal Audit for a Robotic Patient Positioning System

AZDEVICE

Manufacturer
Orthopaedic Surgery & Implants
Compliance
  • CE Marking of a Device for Venous and Lymphatic Circulation - Class I Device

SOMEDICS RD

Manufacturer
Cardiology & Cardiovascular
Compliance Quality
  • ISO 13485 QMS Update
  • Update to the CE Marking Technical Files for Cardiac Stimulation Electrodes

SCHILLER MEDICAL

Distributor
Cardiology & Cardiovascular
Compliance Quality
  • Review of CE Marking Documentation and the ISO 13485 Quality Management System for a Subsidiary of a Defibrillator Manufacturer

ADAPSIA

Manufacturer
Orthopaedic Surgery & Implants
Audit
  • ISO 13485 Internal Audit for Cranio-Maxillofacial Surgical Devices

NOVIGA

Manufacturer
Cardiology & Cardiovascular
Compliance Quality
  • Technical Documentation for CE Marking of Software for Cardiac Analysis and Sleep Apnea Detection
  • Implementation of the ISO 13485 Quality Management System

CARDIORENAL

Manufacturer
Cardiology & Cardiovascular
Compliance Quality
  • CE Marking of a Home Telemonitoring Solution for Patients with Heart Failure
  • Implementation of the ISO 13485:2016 Quality Management System

KEPHALIOS

Manufacturer
Cardiology & Cardiovascular
Audit
  • ISO 13485 Quality System Audit for a Manufacturer of Cardiac Implants

EDEN Innovations

Manufacturer
Cardiology & Cardiovascular
Compliance Outsourced Quality Manager +1 prestation
  • Implementation of the ISO 13485/ISO 9001 Quality Management System
  • Implementation of CE Marking for Connected Operational Defibrillators (DOC)
  • Outsourced Quality Manager Role

STENDO

Manufacturer
Cardiology & Cardiovascular
Compliance
  • Support for CE Marking of Cardiovascular Stimulation Devices

KAPTALIA Monitoring

Manufacturer
Cardiology & Cardiovascular
Audit
  • Audit in accordance with EN 62304 for wireless monitoring systems (ECG, SpO2, blood pressure)

KANOPYMED

Manufacturer
Cardiology & Cardiovascular
Compliance
  • Regulatory support for a risk-scoring algorithm for cardiac decompensation