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
- Development of Standard Operating Procedures (SOPs)
- 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
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