SJR Associates
SJR Associates is a regulatory affairs consulting practice specializing in medical devices and diagnostic products. They provide comprehensive regulatory services, focusing on helping start-ups and small companies define and implement regulatory strategies, establish quality systems, and build responsive regulatory and quality functions. Their approach is pragmatic and cost-effective, aiming to help medical device companies achieve their business goals efficiently.
Industries
Nr. of Employees
small (1-50)
SJR Associates
Products
Point-of-care and cartridge-based diagnostic analyzers (projects supported)
Regulatory and quality support for point-of-care immunoassay, hematology, and clinical chemistry analyzers that use single-use disposable test cartridges.
Breath analysis devices (projects supported)
Regulatory support for breath-based analyzers including indirect calorimetry, exhaled nitric oxide, end-tidal gas analysis, and exhaled breath condensate analyzers.
Electrodiagnostic and physiologic monitoring devices (projects supported)
Regulatory and quality support for devices such as automated auditory brainstem response systems, EEG, EMG, posturography, and non-invasive oxygen saturation monitors.
Medical image analysis and SaMD projects
Regulatory guidance for image analysis software and mobile medical apps including breast ultrasound analysis, dermatology image analysis, retinal imaging, and diabetes data management software. Support includes submissions and SaMD regulatory pathway evaluation.
Point-of-care and cartridge-based diagnostic analyzers (projects supported)
Regulatory and quality support for point-of-care immunoassay, hematology, and clinical chemistry analyzers that use single-use disposable test cartridges.
Breath analysis devices (projects supported)
Regulatory support for breath-based analyzers including indirect calorimetry, exhaled nitric oxide, end-tidal gas analysis, and exhaled breath condensate analyzers.
Electrodiagnostic and physiologic monitoring devices (projects supported)
Regulatory and quality support for devices such as automated auditory brainstem response systems, EEG, EMG, posturography, and non-invasive oxygen saturation monitors.
Medical image analysis and SaMD projects
Regulatory guidance for image analysis software and mobile medical apps including breast ultrasound analysis, dermatology image analysis, retinal imaging, and diabetes data management software. Support includes submissions and SaMD regulatory pathway evaluation.
Services
Regulatory strategy, submission preparation, regulatory intelligence, and agency interaction support for medical devices and IVDs.
Design and implementation of quality management systems, internal audits, inspection readiness, and post-market compliance support.
Development, review, and auditing of design history files, technical files, and design dossiers; coordination of design verification/validation documentation.
Clinical trial strategy, protocol development and review, IRB submission preparation, and clinical monitoring services for device studies.
Regulatory strategy, submission preparation, regulatory intelligence, and agency interaction support for medical devices and IVDs.
Design and implementation of quality management systems, internal audits, inspection readiness, and post-market compliance support.
Development, review, and auditing of design history files, technical files, and design dossiers; coordination of design verification/validation documentation.
Clinical trial strategy, protocol development and review, IRB submission preparation, and clinical monitoring services for device studies.
Expertise Areas
- Regulatory affairs for medical devices and in vitro diagnostics
- Clinical trial design and clinical study monitoring for medical devices
- Quality management systems and compliance (FDA QSR, ISO)
- Post-market surveillance, adverse event reporting, and field actions
Key Technologies
- Point-of-care diagnostics
- In vitro diagnostics (IVD)
- Breath analysis devices (e.g., eNO, end-tidal gas, exhaled breath condensate)
- Electrodiagnostic monitoring (EEG, EMG, auditory brainstem response)