Clinical & Technical Support

OperatingInformation for Manufacturers, Developers and Users

 

FirstClinTech is able to supply experienced Clinical Specialists to Manufacturers, Developers and Distributors of medical devices. Our Clinical Specialists are highly experienced – not only with devices used in the cardiac surgery arena but in many other specialties too. They are located in the major markets of Europe and share a wide language capability.

Based on very flexible working relationships with Clients, we can tailor support services to your needs, and we can grow the relationship as your device is used more often. This type of Consultancy is particularly suited to devices early on in their international application – for example during Clinical Trials designed to capture data leading to the CE-Mark.

We can provide the local infrastructure and expertise which will ensure that your devices are used appropriately, and just in case something does not work out, we can provide immediate 24/7 close support, troubleshooting and remedial actions. Our activities include (but are not limited to):

Training & Education

  • Assistance with developing suitable training materials and courses;
  • Setting-up and running training courses at appropriate labs and hospitals;
  • Providing on- and off-site Training Courses;
  • Providing up-date training in the field;
  • Training and Education of Sales force.

Expert Support

  • 24/7 Advice on device-related issues such as Patient Selection; Study Eligibility; Adverse Event activities; Device Management
    • effective partnering with study sites to increase referrals and recruitment
  • Technical Service (see below)
  • Channel for EU Vigilance Reporting
  • Troubleshooting
  • Explant analysis and handling

Technical Support

If you have electrical or electromechanical equipment that requires service and/or maintenance, FirstClinTech can provide the resources needed. For manufacturers and developers looking to enter the European arena we can provide you with the flexibility you need to ensure that you choose the best and most cost-effective solutions.

With our Partner organisation, TASK Management BV, we can provide all the service and maintenance resources for you. For example

  • Inspection of equipment prior to shipping
  • Periodic service and maintenance
  • Repairs and fault analysis at base or in the field
  • Equipment safety testing
  • Full compliance with manufacturer’s procedures
  • Close cooperation with Clinical Support specialists
  • Effective operation of a rental/loaner pool

 

About our collaboration with TASK Management BV

We share our building with TASK Management’s electronics facilities. TASK has considerable experience working with a wide range of critical medical devices and equipment – for example dialysis and hemofiltration systems, pressure monitoring systems, cardiac output computers etc.

Specialists from FirstClinTech and from TASK have considerable experience working in the field across Europe, including a patient’s home. This can be mandatory in some states for electronic products placed into service – for example carrying out earth leakage current testing.