SoftQuest Systems has been involved in software validation for medical devices for over 20 years with experience of working with over 500 companies (mainly in Israel). We have been involved in numerous submissions to the FDA, CE and the rest of the world.
Our customers include companies developing various medical devices and diagnostic systems, including:
- Monitoring systems
- IVD (In Vitro Diagnostics) systems
- Insulin pumps
- Navigation systems
- CAD (Computer Aided Diagnostics) systems
- Physiotherapy systems
- Remote monitoring and emergency services
- Specific device manufacturers (without software in the product)
- Endoscopes/colonoscopes/colposcopes
- Irrigation systems
- Cameras and data links
- Blood banks
- LIMS (Laboratory Information Systems)
- Nuclear medicine
- Orthopedic surgery systems
- Treatment systems
- Ophthalmic treatment systems
- Cognitive learning systems
- Dental implant planning and tracking
- CT/X-Ray/MRI/mamograph/ultra sound
In addition, we are involved with production and logistics equipment validation for medical device and bio-pharmaceutical companies in all fields. The applications include:
- MRP
- ERP
- Manufacturing machines
- Excel spreadsheet
- Cleanroom control
- Supply chain
- CRM
- Document control
SoftQuest Systems offers comprehensive consulting for software verification & validation and software quality assurance in the medical device and the bio-pharmaceutical field.