Windmills

Medical Devices & Life Sciences

It can be difficult to maintain   high quality healthcare software testing    that complies with FDA regulations and protects the safety of operators and patients. That’s why QualiTest offers a    wide range of healthcare testing services and medical software verification and validation services.

Medical device manufacturers for biotech and pharmaceutical companies must be meticulous in their development process and perform strenuous healthcare software testing and medical software validation and verification. QualiTest delivers high quality healthcare software testing that complies with FDA regulations and protects the safety of operators and patients by using a team of domain experts to create a wide range of healthcare testing services and medical software verification and validation services, so that hospitals, medical labs and patients can use your products.

From my experience working with the team at QualiTest, QualiTest has grown into a powerhouse provider of overall Software Testing solutions both in manual testing and in test automation. The very fact that they specialize in Software Testing only, makes them uniquely positioned in this field and distinctly sets them apart from the rest of the competition in the same industry.

Robu Mohammad, Test Manager, Fuji Medical

Fuji Medical

Features

Our Healthcare and Medical Software Testing and Validation Services include:

  • Verification and Validation Services (V&V Testing)
  • System classification analysis
  • FDA & CE Mark compliance roadmap and analysis (510K, PMA…)
  • Computerized systems Gap Analysis
  • Validation Master Plan (VMP) & Computer Validation Master Plan (cVMP) preparation
  • Validation Protocols preparation & execution
  • 21 CFR Part 11, 820 Risk Assessment, Gap Analysis, developing SOPs and test documents
  • IQ/OQ/PQ
  • Development of Standard Operating Procedures (SOPs)
  • cGMP/GAMP
  • Product and equipment risk assessment
  • Validation & Verification of Processes & Equipment Required By HACCP
  • Product and product-line equipment Risk Assessment
  • Construction of Pharmaceutical, Biotechnology Facilities Design Review