Experience:

SoftQuest Systems has been involved in software validation for medical devices for over
15 years with experience of working with over 350 companies (mainly in Israel).
We have been involved in about 400 submissions to the FDA and an equal amount to the CE.
Our customers include companies developing various medical devices and diagnostic systems,
including:
1.  Monitoring systems
2.  IVD (In Vitro Diagnostics) systems
3.  Insulin pumps
4.  Navigation systems
5.  CAD (Computer Aided Diagnostics) systems
6.  Physiotherapy systems
7.  Remote monitoring and emergency services
8.  Specific device manufacturers (without software in the product)
9.  Endoscopes/colonoscopes/colposcopes
10 Irrigation systems
11. Cameras and data links
12. Blood banks
13. LIMS (Laboratory Information Systems) 
14, Nuclear medicine
15. Orthopedic surgery systems
16. Treatment systems
17. Ophthalmic treatment systems
18. Cognitive learning systems
19. Dental implant planning and tracking
20. 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:
 
1. MRP
2. ERP
3. Manufacturing machines
4. Excel spreadsheet
5. Cleanroom control
6. Supply chain
7. CRM
8. Document control
 
SoftQuest Systems offers comprehensive consulting for software verification & validation and software quality assurance in the medical device and the bio-pharmaceutical field.