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Testing Medical Device Software

The landscape of IT healthcare and software is changing has changed considerably over the last few years. With more and more people getting sick from unknown diseases, hospitals and hospitals, pharma companies, labs and healthcare services, clinical labs, diagnostic centres, OEMS in medical device space, ISVs, and research organizations have all taken to technology to expedite the time to market. The world is seeing a lot of growth in mental health and wellness space. Hospitals and going digital and their software is interacting with numerous devices. It is extremely important that the interaction and software and hardware is seamless and hence Medical Device Software Testing is an activity that is unavoidable. Not just the functionality, but the security, performance and conformance to ISO guidelines (verification) are all important for any such software. A malfunction can lead to a disastrous outcome as a life is at stake.

Our Expertise

ImpactQA has expertise on ISO13485, 21 CFR Part 11 and IEC 60601 3rd Edition in the areas of:

  • Spine
  • ENT
  • Trauma
  • Ophthalmic
  • IOT Gateways
  • Embedded electronics
  • Remote Monitoring Systems
  • Emergency Care and Single Use Devices

We are proficient at working within regulated environments such as US FDA and the EU (ISO13485, CER, 21 CFR Part 820 Quality Management Systems along with ISO14971 and IEC62304)

Our skills also include developing Design Dossiers (DHF/Tech Files), 510 (K) applications, UDI implementation, Remediation of the Class I, II and III products, and CAPA Management.

Our partner companies have capabilities in Mechanical, Electrical, Quality and Regulatory of medical devices in major markets including USA and Europe. We have experts with 15+ years’ experience in medical devices with capabilities in Orthopaedics, Cardiovascular, Trauma, Spine, IVD and hospital disposables. We have capabilities working on products from concepts to manufacturing.

Our Services

We offer the following medical devices software testing:

Functional Testing

Conformance and Compliance Testing

Review Design Specifications and Gap Analysis

Security Testing

IoT Testing

Performance (Load and Stress) Testing

System Integration & Interface Testing

Enterprise Workflow Testing

Test Process Improvement

Devising QA and Testing Strategy

Our Experience

ImpactQA also has extensive experience in regulations per UD FDA and EU MDR. Here is the list of primary services we offer.

  • Mechanical Design
  • Quality Assurance services
  • Regulatory Services
  • Electronics Design and Development
  • Failure Modes & Effects Analysis (FMEA)
  • Code Reviews

Our Key Domains

Our expertise extends to the areas of:

  • Orthopaedics
  • Otology
  • Spine
  • Trauma
  • ENT
  • Remote Monitoring Systems
  • IOT Gateways
  • Embedded electronics
  • Emergency Care and
  • Single Use Devices

HealthCare & Life Sciences

Life Sciences organization have to deal a lot with regulators and have to ensure that their systems perform as per the pre-determined specifications. With an aging population globally, the life sciences organizations are undergoing a paradigm shift with focus on the chronic diseases while keeping a close eye on, tightening regulatory controls. The organization, world over, are under pressure to adopt digital transformation while keeping the costs low. However, Life Sciences organizations spend a lot of effort in making sure the system performs consistently to produce its pre-determined specifications and quality attributes. Verification and Validation are key processes in the life cycle of a Healthcare and Life Science systems.

Though the activities required to meet the regulatory requirements are well defined, the experience in designing and executing such processes are important in an organization to make this a standard and part of the overall organization need.

Our Key Areas

ImpactQA has been helping clients in the following areas:


Health Level 7 (HL7)

GAMP and 21 CFR part 11

HIPAA Compliance

21 CFR part 820

DICOM Standards



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