Medical Devices & Life Sciences

The FDA recalled 39 medical devices in 2016.  You may know healthcare and technology and care about quality, but edge cases and compliance issues require independent testing pros to limit your risk.  Serious quality issues below recall level are also easily preventable.  Let us help optimize your device, advise you and anticipate prepping for future changes so that you comply with FDA regulations and ensure operator and patient safety. 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 like you must be meticulous in your development process and perform comprehensive healthcare software testing and medical software validation and verification. QualiTest’s teams of domain experts, focused on safety and compliance, use their high-quality healthcare testing services and medical software verification and validation services, so that hospitals, medical labs and patients can use your products.  Our accelerators, pre-built environments, TCoE’s and automation help with testing speed and thoroughness.

Areas of concern include:

  • Compliance and design: ICD-10, HIPAA, 5010, ARRA/HITECH, Meaningful Use, PPACA, FDA (510(k), PMA, etc.), CE Marking (Europe), CMDR (Canada), AMAR (Israel), CDSCO (India), IQ/OQ/PQ, cGMP/GAMP, HACCP IV&V, 21 CFR Parts 11 and 820, Validation Master Plan (VMP) & Computer Validation Master Plan (cVMP) preparation, Risk Assessment, Gap Analysis, developing SOPs
  • Security: Malware and data breaches continue to grow in sophistication and prevalence. Frequent device connections increase the potential for malware.  Standardized default passwords pose risks.
  • Integration Testing: Medical devices are integrate into hospital networks, transfer data and have CRUD access to records.
  • Usability: Rebooting a hung computer may be trivial, but a surgical device, health monitor or life support system requires a much higher level of stability and an easy way to flush errors without shutting down. Likewise, an “Are you sure?” may be needed as a potential barrier to unexpected input.
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