Biomedical & Med Device
Physiology/biophysics, biopotential/biosignal electronics, medical device design, regulatory frameworks, and digital health.
279 topics · 5 with articles
Intern Engineer· 0 of 40
- 12-Lead ECG: Electrode Placement and Lead SystemArticle coming
- Acoustic Properties of Biological TissueArticle coming
- Action Potential: Depolarization, RepolarizationArticle coming
- Autonomic Nervous System: HRV MeasurementArticle coming
- Blood Pressure: Systolic, Diastolic, Pulse PressureArticle coming
- Body Composition: Bioimpedance Analysis (BIA)Article coming
- Brain Electrical Activity: EEG Rhythms Alpha, BetaArticle coming
- Cardiac Biomarkers: Troponin, BNP, CRPArticle coming
- Cardiac Cycle: Systole, Diastole, Stroke VolumeArticle coming
- Cardiac Electrical Activity: SA Node, AV NodeArticle coming
- Cell Membrane Resting Potential and Ion ChannelsArticle coming
- Coagulation Cascade and INR MonitoringArticle coming
- Continuous Ambulatory Blood Pressure MonitoringArticle coming
- ECG Waveform: P, QRS, T, U ComponentsArticle coming
- EMG Signal: Motor Unit Action PotentialArticle coming
- Fetal Heart Rate Monitoring (CTG)Article coming
- Galvanic Skin Response (GSR) and EDRArticle coming
- Gastrointestinal Motility: Capsule EndoscopyArticle coming
- Glucose Metabolism and Insulin ResistanceArticle coming
- Hemodynamics: CO, SVR, Frank-Starling LawArticle coming
- Intracranial Pressure (ICP) MonitoringArticle coming
- Intraocular Pressure and Tonometry BasicsArticle coming
- Liver Function Markers: ALT, AST, ALPArticle coming
- MRI: Proton Precession and Larmor FrequencyArticle coming
- Microbiome Sensing TechnologiesArticle coming
- Microcirculation and Laser Doppler FlowmetryArticle coming
- NIRS (Near-Infrared Spectroscopy) Tissue OxyArticle coming
- Nerve Conduction Velocity MeasurementArticle coming
- Organ-on-Chip Microfluidic DeviceArticle coming
- Oxygen Transport: Hb-O2 Dissociation CurveArticle coming
- Photoplethysmography (PPG) Beer-Lambert BasisArticle coming
- Renal Function: GFR, Creatinine, BUNArticle coming
- Respiratory Mechanics: TV, RV, FRC, FVC, FEV1Article coming
- Retinal Imaging: OCT PrincipleArticle coming
- Skin Electrical Properties: Electrode-Skin InterfaceArticle coming
- Sleep Stages and Polysomnography SensorsArticle coming
- SpO2 Physiology and Lambert-Beer LawArticle coming
- Thermoregulation: Core and Skin TemperatureArticle coming
- Ultrasound Acoustic Impedance and ReflectionArticle coming
- X-Ray Interaction with TissueArticle coming
Junior Engineer· 4 of 40
- Accelerometer for Activity and Fall DetectionRead
- Analog Front-End Power Budget for WearableRead
- Bioimpedance Spectroscopy (BIS) SystemArticle coming
- Body Area Network (BAN) IEEE 802.15.6Article coming
- Body Temperature: IR Thermopile CircuitRead
- Cochlear Implant Signal Processing ChainArticle coming
- Continuous Glucose Monitor (CGM) CalibrationArticle coming
- Deep Brain Stimulator (DBS) HW ArchitectureArticle coming
- ECG AFE: ADS1291, MAX30003, AD8232Read
- ECG Front-End: Right Leg Drive (RLD) CircuitArticle coming
- EEG Amplifier: Input Impedance, CMRArticle coming
- EMG Signal Conditioning and Envelope DetectionArticle coming
- Electrode-Skin Interface: Ag/AgCl, Dry ElectrodesArticle coming
- Galvanic Skin Response Measurement CircuitArticle coming
- Glucose Amperometric Sensor: Working ElectrodeArticle coming
- Gyroscope for Patient Posture MonitoringArticle coming
- Hermetic Packaging and Feedthrough DesignArticle coming
- Impedance Cardiography (ICG) CircuitArticle coming
- Implantable Cardioverter Defibrillator (ICD) HWArticle coming
- Instrumentation Amplifier: CMRR, PSRR, NoiseArticle coming
- Local Field Potential Recording CircuitArticle coming
- Low-Power ADC for Wearable MedicalArticle coming
- MAX86150 ECG and PPG Sensor IntegrationArticle coming
- MEMS Pressure Sensor for IntracranialArticle coming
- NFC-Powered Implant CommunicationArticle coming
- Neural Recording Amplifier for ImplantArticle coming
- Optical Heart Rate: Contact vs. Non-ContactArticle coming
- PPG Circuit: LED Driver, Photodiode, TIAArticle coming
- PPG Noise: Motion Artifact ReductionArticle coming
- Pacemaker Lead Sensing and Pacing CircuitArticle coming
- Photoplethysmography Optical DesignArticle coming
- Pressure Sensor for Non-Invasive BPArticle coming
- Pulse Transit Time (PTT) for BP EstimateArticle coming
- RF Energy Harvesting for ImplantableArticle coming
- Retinal Prosthesis Stimulator CircuitArticle coming
- SpO2 Red/IR LED Ratio AlgorithmArticle coming
- Ultrasound Pulser and T/R Switch CircuitArticle coming
- Ultrasound Transducer: Piezoelectric ElementArticle coming
- Wireless Capsule Endoscopy ElectronicsArticle coming
- Wireless Power Transfer (WPT) for ImplantArticle coming
Middle Engineer· 0 of 80
- 21 CFR Part 820: Quality System RegulationArticle coming
- 3D-Printed Patient-Specific Implant DesignArticle coming
- ANSI/AAMI ES60601-1 US AdaptationsArticle coming
- Anesthesia Machine Gas Circuit DesignArticle coming
- Australia TGA Therapeutic Goods AdministrationArticle coming
- Battery Selection: Primary vs. RechargeableArticle coming
- Biocompatibility: ISO 10993 Test SelectionArticle coming
- CE Marking: Self-Declaration vs. Notified BodyArticle coming
- Catheter and Guidewire Design BasicsArticle coming
- China NMPA Medical Device RegistrationArticle coming
- Cleanroom Design: ISO 14644 Class 7/8Article coming
- Closed-Loop Drug Delivery System DesignArticle coming
- Combination Product Regulatory StrategyArticle coming
- Design Input: Customer, Clinical, RegulatoryArticle coming
- Design Output: Drawings, Specifications, SOPsArticle coming
- Design Transfer to Manufacturing ProcessArticle coming
- Design Validation Plan and ReportArticle coming
- Design Verification Plan and Report (DVP&R)Article coming
- Device Master Record (DMR) and Production RecordArticle coming
- Dialysis Machine Blood Path DesignArticle coming
- Disposable Sensor Manufacturing ConsiderationsArticle coming
- EN 60601-1 Creepage, Clearance, Protective EarthArticle coming
- EN 62133: Secondary Battery SafetyArticle coming
- EU MDR 2017/745 Technical DocumentationArticle coming
- EU MDR Annex IX Conformity Assessment RoutesArticle coming
- EU MDR Annex XIV: Clinical EvaluationArticle coming
- EU MDR Annex XV: Clinical InvestigationsArticle coming
- EU MDR Article 61: Clinical EvidenceArticle coming
- EU MDR EUDAMED Registration ProcessArticle coming
- Electrosurgery RF Generator DesignArticle coming
- FDA 510(k) Predicate Device IdentificationArticle coming
- FDA 510(k) Premarket Notification ProcessArticle coming
- FDA Breakthrough Device DesignationArticle coming
- FDA De Novo Classification RequestArticle coming
- FDA PMA (Premarket Approval) for Class IIIArticle coming
- FDA Pre-Submission (Q-Sub) Meeting StrategyArticle coming
- FDA SaMD Guidance: Categories and PathArticle coming
- GDPR Implications for Medical DataArticle coming
- HIPAA Technical Safeguards for Medical ITArticle coming
- IEC 60601-1-11: Home Healthcare RequirementsArticle coming
- IEC 60601-1-2: EMC for Medical EquipmentArticle coming
- IEC 60601-2-27: ECG Equipment RequirementsArticle coming
- IEC 62304: Software Lifecycle for MedicalArticle coming
- IEC 62366-1: Usability Engineering LifecycleArticle coming
- IEC 80001-1: Network Safety for MedicalArticle coming
- IEC 82304: Health Software SafetyArticle coming
- IMDRF Cybersecurity Guidance for DevicesArticle coming
- ISO 10993-1 Risk-Based BiocompatibilityArticle coming
- ISO 10993-10: Sensitization and IrritationArticle coming
- ISO 10993-5: Cytotoxicity TestArticle coming
- ISO 11135: EO Sterilization ValidationArticle coming
- ISO 11137: Radiation Sterilization ValidationArticle coming
- ISO 13485 Internal Audit ProcessArticle coming
- ISO 13485: QMS for Medical DevicesArticle coming
- ISO 14971 Risk Management (see Safety col)Article coming
- ISO 17665: Moist Heat Sterilization ValidationArticle coming
- IVDR 2017/746: IVD Classification Rules 1-7Article coming
- Implant Mechanical Design: Fatigue, CorrosionArticle coming
- Implantable MEMS Pressure SensorArticle coming
- Infusion Pump: Occlusion Detection, AccuracyArticle coming
- Japan PMDA Shonin / Ninsho ApprovalArticle coming
- MDSAP Multi-Market Audit (FDA, Health Canada)Article coming
- Medical Device Classification: FDA Class I/II/IIIArticle coming
- Medical Device Design History File (DHF)Article coming
- Medical Device Labeling RequirementsArticle coming
- Medical-Grade Plastic and Material SelectionArticle coming
- Notified Body Audit PreparationArticle coming
- Optical Sensor Integration for WearableArticle coming
- PCB Design Rules: Creepage and ClearanceArticle coming
- Product Requirement Document (PRD) for MedicalArticle coming
- Single-Use Device (SUD) PolicyArticle coming
- South Korea MFDS Registration ProcessArticle coming
- Sterility Assurance Level (SAL) 10^-6Article coming
- Sterilization Method: EO, Gamma, E-BeamArticle coming
- Surgical Robot Mechanism DesignArticle coming
- Technical File vs. Design Dossier StructureArticle coming
- Tissue Ablation: RF, Microwave, LaserArticle coming
- Vascular Access Device Design PrinciplesArticle coming
- Ventilator Circuit and Respiratory EquipmentArticle coming
- Wearable Medical PCB Layout ConsiderationsArticle coming
Senior Engineer· 1 of 40
- Accelerated Aging and Shelf-Life TestingArticle coming
- Adverse Event Reporting to FDA (MAUDE)Article coming
- Applied Part and Enclosure Leakage TestArticle coming
- CAPA Effectiveness Check and ClosureArticle coming
- Complaint Handling Process and TrackingArticle coming
- Comprehensive Residual Risk EvaluationArticle coming
- Corrective and Preventive Action (CAPA)Article coming
- Dielectric Strength Test (Hi-Pot Test)Article coming
- Drop Test and Mechanical Impact TestArticle coming
- EMC Test IEC 60601-1-2Article coming
- Electrical Safety: Protective Earth, LeakageRead
- Event Tree Analysis (ETA)Article coming
- FMEA for Medical Devices: Design and ProcessArticle coming
- FMEDA (Failure Modes, Effects, Diagnostic)Article coming
- Fault Tree Analysis (FTA) for Medical SystemsArticle coming
- Hazard Identification and Hazard SituationArticle coming
- Human Factors Formative and Summative EvalArticle coming
- IEC 60601-1 Type B, BF, CF Applied PartArticle coming
- IP Rating Test (IEC 60529)Article coming
- ISO 14971:2019 Risk Management LifecycleArticle coming
- Mains Isolation Test for Patient DevicesArticle coming
- Non-Conforming Product Control ProcessArticle coming
- Patient Leakage Current Limits (<10 µA for CF)Article coming
- Post-Market Clinical Follow-up (PMCF) PlanArticle coming
- Post-Market Surveillance (PMS) PlanArticle coming
- Residual Risk Acceptability CriteriaArticle coming
- Risk Control Measure VerificationArticle coming
- Risk Control Option AnalysisArticle coming
- Risk Estimation: Severity x Probability MatrixArticle coming
- Risk Evaluation and Acceptable Risk CriteriaArticle coming
- Risk Management Plan (RMP) DocumentArticle coming
- Risk-Benefit Analysis for Medical DevicesArticle coming
- Software Hazard Analysis for IEC 62304Article coming
- Stack-up Analysis for Electrical SafetyArticle coming
- Sterility and Bioburden Testing ProtocolsArticle coming
- Temperature and Humidity Cycling TestArticle coming
- Transport and Packaging Test (ASTM D4169)Article coming
- Usability Study: Use Errors and Near MissesArticle coming
- Vigilance Reporting: MDR and Serious IncidentArticle coming
- Zonal Safety Analysis (ZSA)Article coming
Staff Engineer· 0 of 40
- Adaptive Clinical Trial Design (Bayesian)Article coming
- Adverse Event Classification: Serious, Unantici.Article coming
- Analog Front-End Characterization: BW, OffsetArticle coming
- Battery Characterization: Capacity, ResistanceArticle coming
- Bench Testing Protocol Design for MedicalArticle coming
- Biostatistics: Primary Endpoint SelectionArticle coming
- Calibration and Measurement Uncertainty (GUM)Article coming
- Clinical Data Collection: eCRF, EDC (REDCap)Article coming
- Clinical Investigation Plan (CIP) Protocol DesignArticle coming
- Clinical Site Selection and Investigator TrainingArticle coming
- Clinical Study Report (CSR) WritingArticle coming
- Clinical Trial Phases (I, II, III, IV) OverviewArticle coming
- Clinical Usability Study: Summative EvaluationArticle coming
- Comparative Effectiveness Study DesignArticle coming
- Compassionate Use and Expanded Access ProgramArticle coming
- Data Monitoring Committee (DMC) CharterArticle coming
- ECG Simulator (Fluke ProSim 4) UsageArticle coming
- EUDAMED Clinical Investigation RegistrationArticle coming
- Electrical Performance: SNR, CMRR, Noise FloorArticle coming
- FDA IDE (Investigational Device Exemption)Article coming
- GLP Compliance for Preclinical StudiesArticle coming
- Global Market Regulatory Strategy AlignmentArticle coming
- Good Clinical Practice (GCP) GuidelinesArticle coming
- Health Economics and Outcomes Research (HEOR)Article coming
- Home-Use Study Protocol (IEC 60601-1-11)Article coming
- Informed Consent Process and DocumentArticle coming
- Institutional Review Board (IRB) Ethics CommitteeArticle coming
- Measurement System Analysis: Gage R&RArticle coming
- Meta-Analysis for Clinical EvidenceArticle coming
- Phantom Test: Ultrasound and MRI Tissue PhantomArticle coming
- Post-Market Clinical Investigation DesignArticle coming
- Preclinical Animal Study Design: GLP RequirementsArticle coming
- Randomization and Blinding StrategiesArticle coming
- Real-World Evidence (RWE) Study DesignArticle coming
- Registry-Based Post-Market StudiesArticle coming
- Regulatory Compliance Lab (ISO 17025)Article coming
- Regulatory Submission of Clinical DataArticle coming
- Sample Size Calculation: Power and Effect SizeArticle coming
- Systematic Literature Review for Clinical EvalArticle coming
- Wireless Connectivity Testing: BLE, Wi-Fi, NFCArticle coming
Distinguished Engineer· 0 of 39
- 12-Lead ECG AI Classification (DeepMind, AliveCor)Article coming
- AI Bias: Gender and Ethnicity in Medical DevicesArticle coming
- AI-Enabled Drug Discovery InterfaceArticle coming
- Algorithm Transparency and Model CardArticle coming
- Arrhythmia Detection with CNN (Physionet)Article coming
- CGM AI Calibration and Glucose PredictionArticle coming
- Chest X-Ray AI (CheXNet, CheXpert)Article coming
- Clinical Decision Support System (CDSS) IntegrationArticle coming
- Clinical NLP: ICD Coding and EHR SummarizationArticle coming
- Continuous Glucose Monitor AI Algorithm DesignArticle coming
- Convergence: Genomics + Imaging + AIArticle coming
- DICOM Standard: SOP Classes, IODArticle coming
- Differential Privacy for Health DataArticle coming
- Digital Therapeutics (DTx) RegulationArticle coming
- ECG Denoising with Deep Learning (U-Net)Article coming
- EHR Integration: Epic, Cerner, Allscripts APIsArticle coming
- EU MDR Annex XIV Clinical Evidence for AIArticle coming
- Explainable AI (XAI) for Clinical Decision SupportArticle coming
- FDA AI/ML-Based SaMD Action PlanArticle coming
- Federated Learning for Clinical AI PrivacyArticle coming
- Foundation Model for Medical AI (Med-PaLM 2)Article coming
- GDPR Article 9: Special Category Health DataArticle coming
- HIPAA PHI De-Identification MethodsArticle coming
- HL7 FHIR R4 API for Medical Data ExchangeArticle coming
- Human Augmentation: Exoskeleton and NeuroprostheticsArticle coming
- IoT Medical Device Security (FDA 2023)Article coming
- MRI Brain Segmentation (FreeSurfer, nnU-Net)Article coming
- PPG-Based Blood Pressure Estimation (AI)Article coming
- Pathology AI: Whole Slide Image AnalysisArticle coming
- Precision Medicine Platform ArchitectureArticle coming
- Predetermined Change Control Plan (PCCP) for AIArticle coming
- Quantum Sensing for Medical DiagnosticsArticle coming
- Remote Patient Monitoring (RPM) Platform DesignArticle coming
- Retinal Image Classification (Diabetic Retinopathy)Article coming
- Sepsis Early Warning AlgorithmArticle coming
- Software as a Medical Device (SaMD): FDA CategoriesArticle coming
- Synthetic Clinical Data Generation for AI TrainingArticle coming
- Telemedicine Platform ArchitectureArticle coming
- Wearable Medical App FDA 510(k) StrategyArticle coming