REGULATORY SERVICES
QUALITY_SYSTEM
STANDARDS
DESIGN_CONTROL
RISK_MANAGEMENT
SYSTEM_MODELING
REQUIREMENTS
DESIGN_DESCRIPTION
UNIT_TESTS
VERIFICATION
VALIDATION
TRACEABILITY
AUTOMATED_V&V
Design and implementation of regulatory compliance systems is a major area of focus for Syprosoft Engineering. We have worked on all aspects of regulation mandated quality systems and processes. For details, click on the buttons above.

Regulatory Clearance EXPERIENCE

Syprosoft Engineering has extensive knowledge of the stringent regulatory requirements for higher risk medical devices including PMA, De Novo, and 510(k). We have helped clients implement quality processes to comply with the latest regulations. Even a small start-up has to have a quality system that is compliant with the regulations including cybersecurity. One way to minimize regulatory burdens is to use a risk based approach. We have helped our clients prepare risk assessments by using both production data and published literature. We also follow many IEC and ISO standards and FDA guidance in our work. Below are examples of some products that we developed the verification and validation (V&V) plans, performed the tests and prepared PMA and 510(k) filings.
Trans-Myocardial RevascularizationQualified an upgraded cardiac laser by using efficacy tests. Demonstrated no impact on creation of myocardial channels during TMR thus supporting a successful PMA Supplement filing.
SPECT Image Analysis Designed algorithms for processing liver/spleen scans to determine liver function. Developed V&V protocols and reports for a successful 510(k).
Blood Processing Developed some of the software and performed V&V for a blood collection and processing system. Prepared protocols/reports for a 510(k) filing.
Implanted Cardio Assist PumpDeveloped risk based test protocols at the unit, integration and system levels for V&V of this PMA device. Tested and documented in formal reports.
Orthognathic SurgeryPrepared FDA documentation for an orthognathic surgery planning system including a positioning splint. Successfully obtained a 510(k) clearance.
Intra-operative AberrometerFormulated the software V&V plan and wrote the test protocols. Prepared test reports for a successful 510(k) filing.
Stroke TherapyDeveloped the GUI and embedded control software for a system to treat ischemic stroke using low-level infra-red laser therapy. Prepared V&V documents for this PMA device.
StimulatElectrical ionPerformed verification and validation and prepared a 510(k) package for a successful clearance for this device to treat viral cold sores.
Vital Signs MonitorDeveloped V&V plan, test protocols and reports for an innovative bed-sheet sensor based vital signs monitor for a 510(k) filing.
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