Medical Software Testing Services

Product Details

Medical device manufacturers, Biotech and Pharmaceutical companies must be meticulous in their development process and perform strenuous medical software Verification and Validation Testing. QualiTest has created a wide range of Healthcare Testing Services and Medical Software Validation Services using a team of domain experts, to deliver high quality medical software testing that complies with FDA regulations, and protects the safety of operators and patients.


Our Healthcare & Medical Software Testing 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 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