Biomedical & Med Device
Physiology/biophysics, biopotential/biosignal electronics, medical device design, regulatory frameworks, and digital health.
279 topics · 0 with articles
Intern Engineer· 40
- 12-Lead ECG: Electrode Placement and Lead System
- Acoustic Properties of Biological Tissue
- Action Potential: Depolarization, Repolarization
- Autonomic Nervous System: HRV Measurement
- Blood Pressure: Systolic, Diastolic, Pulse Pressure
- Body Composition: Bioimpedance Analysis (BIA)
- Brain Electrical Activity: EEG Rhythms Alpha, Beta
- Cardiac Biomarkers: Troponin, BNP, CRP
- Cardiac Cycle: Systole, Diastole, Stroke Volume
- Cardiac Electrical Activity: SA Node, AV Node
- Cell Membrane Resting Potential and Ion Channels
- Coagulation Cascade and INR Monitoring
- Continuous Ambulatory Blood Pressure Monitoring
- ECG Waveform: P, QRS, T, U Components
- EMG Signal: Motor Unit Action Potential
- Fetal Heart Rate Monitoring (CTG)
- Galvanic Skin Response (GSR) and EDR
- Gastrointestinal Motility: Capsule Endoscopy
- Glucose Metabolism and Insulin Resistance
- Hemodynamics: CO, SVR, Frank-Starling Law
- Intracranial Pressure (ICP) Monitoring
- Intraocular Pressure and Tonometry Basics
- Liver Function Markers: ALT, AST, ALP
- MRI: Proton Precession and Larmor Frequency
- Microbiome Sensing Technologies
- Microcirculation and Laser Doppler Flowmetry
- NIRS (Near-Infrared Spectroscopy) Tissue Oxy
- Nerve Conduction Velocity Measurement
- Organ-on-Chip Microfluidic Device
- Oxygen Transport: Hb-O2 Dissociation Curve
- Photoplethysmography (PPG) Beer-Lambert Basis
- Renal Function: GFR, Creatinine, BUN
- Respiratory Mechanics: TV, RV, FRC, FVC, FEV1
- Retinal Imaging: OCT Principle
- Skin Electrical Properties: Electrode-Skin Interface
- Sleep Stages and Polysomnography Sensors
- SpO2 Physiology and Lambert-Beer Law
- Thermoregulation: Core and Skin Temperature
- Ultrasound Acoustic Impedance and Reflection
- X-Ray Interaction with Tissue
Junior Engineer· 40
- Accelerometer for Activity and Fall Detection
- Analog Front-End Power Budget for Wearable
- Bioimpedance Spectroscopy (BIS) System
- Body Area Network (BAN) IEEE 802.15.6
- Body Temperature: IR Thermopile Circuit
- Cochlear Implant Signal Processing Chain
- Continuous Glucose Monitor (CGM) Calibration
- Deep Brain Stimulator (DBS) HW Architecture
- ECG AFE: ADS1291, MAX30003, AD8232
- ECG Front-End: Right Leg Drive (RLD) Circuit
- EEG Amplifier: Input Impedance, CMR
- EMG Signal Conditioning and Envelope Detection
- Electrode-Skin Interface: Ag/AgCl, Dry Electrodes
- Galvanic Skin Response Measurement Circuit
- Glucose Amperometric Sensor: Working Electrode
- Gyroscope for Patient Posture Monitoring
- Hermetic Packaging and Feedthrough Design
- Impedance Cardiography (ICG) Circuit
- Implantable Cardioverter Defibrillator (ICD) HW
- Instrumentation Amplifier: CMRR, PSRR, Noise
- Local Field Potential Recording Circuit
- Low-Power ADC for Wearable Medical
- MAX86150 ECG and PPG Sensor Integration
- MEMS Pressure Sensor for Intracranial
- NFC-Powered Implant Communication
- Neural Recording Amplifier for Implant
- Optical Heart Rate: Contact vs. Non-Contact
- PPG Circuit: LED Driver, Photodiode, TIA
- PPG Noise: Motion Artifact Reduction
- Pacemaker Lead Sensing and Pacing Circuit
- Photoplethysmography Optical Design
- Pressure Sensor for Non-Invasive BP
- Pulse Transit Time (PTT) for BP Estimate
- RF Energy Harvesting for Implantable
- Retinal Prosthesis Stimulator Circuit
- SpO2 Red/IR LED Ratio Algorithm
- Ultrasound Pulser and T/R Switch Circuit
- Ultrasound Transducer: Piezoelectric Element
- Wireless Capsule Endoscopy Electronics
- Wireless Power Transfer (WPT) for Implant
Middle Engineer· 80
- 21 CFR Part 820: Quality System Regulation
- 3D-Printed Patient-Specific Implant Design
- ANSI/AAMI ES60601-1 US Adaptations
- Anesthesia Machine Gas Circuit Design
- Australia TGA Therapeutic Goods Administration
- Battery Selection: Primary vs. Rechargeable
- Biocompatibility: ISO 10993 Test Selection
- CE Marking: Self-Declaration vs. Notified Body
- Catheter and Guidewire Design Basics
- China NMPA Medical Device Registration
- Cleanroom Design: ISO 14644 Class 7/8
- Closed-Loop Drug Delivery System Design
- Combination Product Regulatory Strategy
- Design Input: Customer, Clinical, Regulatory
- Design Output: Drawings, Specifications, SOPs
- Design Transfer to Manufacturing Process
- Design Validation Plan and Report
- Design Verification Plan and Report (DVP&R)
- Device Master Record (DMR) and Production Record
- Dialysis Machine Blood Path Design
- Disposable Sensor Manufacturing Considerations
- EN 60601-1 Creepage, Clearance, Protective Earth
- EN 62133: Secondary Battery Safety
- EU MDR 2017/745 Technical Documentation
- EU MDR Annex IX Conformity Assessment Routes
- EU MDR Annex XIV: Clinical Evaluation
- EU MDR Annex XV: Clinical Investigations
- EU MDR Article 61: Clinical Evidence
- EU MDR EUDAMED Registration Process
- Electrosurgery RF Generator Design
- FDA 510(k) Predicate Device Identification
- FDA 510(k) Premarket Notification Process
- FDA Breakthrough Device Designation
- FDA De Novo Classification Request
- FDA PMA (Premarket Approval) for Class III
- FDA Pre-Submission (Q-Sub) Meeting Strategy
- FDA SaMD Guidance: Categories and Path
- GDPR Implications for Medical Data
- HIPAA Technical Safeguards for Medical IT
- IEC 60601-1-11: Home Healthcare Requirements
- IEC 60601-1-2: EMC for Medical Equipment
- IEC 60601-2-27: ECG Equipment Requirements
- IEC 62304: Software Lifecycle for Medical
- IEC 62366-1: Usability Engineering Lifecycle
- IEC 80001-1: Network Safety for Medical
- IEC 82304: Health Software Safety
- IMDRF Cybersecurity Guidance for Devices
- ISO 10993-1 Risk-Based Biocompatibility
- ISO 10993-10: Sensitization and Irritation
- ISO 10993-5: Cytotoxicity Test
- ISO 11135: EO Sterilization Validation
- ISO 11137: Radiation Sterilization Validation
- ISO 13485 Internal Audit Process
- ISO 13485: QMS for Medical Devices
- ISO 14971 Risk Management (see Safety col)
- ISO 17665: Moist Heat Sterilization Validation
- IVDR 2017/746: IVD Classification Rules 1-7
- Implant Mechanical Design: Fatigue, Corrosion
- Implantable MEMS Pressure Sensor
- Infusion Pump: Occlusion Detection, Accuracy
- Japan PMDA Shonin / Ninsho Approval
- MDSAP Multi-Market Audit (FDA, Health Canada)
- Medical Device Classification: FDA Class I/II/III
- Medical Device Design History File (DHF)
- Medical Device Labeling Requirements
- Medical-Grade Plastic and Material Selection
- Notified Body Audit Preparation
- Optical Sensor Integration for Wearable
- PCB Design Rules: Creepage and Clearance
- Product Requirement Document (PRD) for Medical
- Single-Use Device (SUD) Policy
- South Korea MFDS Registration Process
- Sterility Assurance Level (SAL) 10^-6
- Sterilization Method: EO, Gamma, E-Beam
- Surgical Robot Mechanism Design
- Technical File vs. Design Dossier Structure
- Tissue Ablation: RF, Microwave, Laser
- Vascular Access Device Design Principles
- Ventilator Circuit and Respiratory Equipment
- Wearable Medical PCB Layout Considerations
Senior Engineer· 40
- Accelerated Aging and Shelf-Life Testing
- Adverse Event Reporting to FDA (MAUDE)
- Applied Part and Enclosure Leakage Test
- CAPA Effectiveness Check and Closure
- Complaint Handling Process and Tracking
- Comprehensive Residual Risk Evaluation
- Corrective and Preventive Action (CAPA)
- Dielectric Strength Test (Hi-Pot Test)
- Drop Test and Mechanical Impact Test
- EMC Test IEC 60601-1-2
- Electrical Safety: Protective Earth, Leakage
- Event Tree Analysis (ETA)
- FMEA for Medical Devices: Design and Process
- FMEDA (Failure Modes, Effects, Diagnostic)
- Fault Tree Analysis (FTA) for Medical Systems
- Hazard Identification and Hazard Situation
- Human Factors Formative and Summative Eval
- IEC 60601-1 Type B, BF, CF Applied Part
- IP Rating Test (IEC 60529)
- ISO 14971:2019 Risk Management Lifecycle
- Mains Isolation Test for Patient Devices
- Non-Conforming Product Control Process
- Patient Leakage Current Limits (<10 µA for CF)
- Post-Market Clinical Follow-up (PMCF) Plan
- Post-Market Surveillance (PMS) Plan
- Residual Risk Acceptability Criteria
- Risk Control Measure Verification
- Risk Control Option Analysis
- Risk Estimation: Severity x Probability Matrix
- Risk Evaluation and Acceptable Risk Criteria
- Risk Management Plan (RMP) Document
- Risk-Benefit Analysis for Medical Devices
- Software Hazard Analysis for IEC 62304
- Stack-up Analysis for Electrical Safety
- Sterility and Bioburden Testing Protocols
- Temperature and Humidity Cycling Test
- Transport and Packaging Test (ASTM D4169)
- Usability Study: Use Errors and Near Misses
- Vigilance Reporting: MDR and Serious Incident
- Zonal Safety Analysis (ZSA)
Staff Engineer· 40
- Adaptive Clinical Trial Design (Bayesian)
- Adverse Event Classification: Serious, Unantici.
- Analog Front-End Characterization: BW, Offset
- Battery Characterization: Capacity, Resistance
- Bench Testing Protocol Design for Medical
- Biostatistics: Primary Endpoint Selection
- Calibration and Measurement Uncertainty (GUM)
- Clinical Data Collection: eCRF, EDC (REDCap)
- Clinical Investigation Plan (CIP) Protocol Design
- Clinical Site Selection and Investigator Training
- Clinical Study Report (CSR) Writing
- Clinical Trial Phases (I, II, III, IV) Overview
- Clinical Usability Study: Summative Evaluation
- Comparative Effectiveness Study Design
- Compassionate Use and Expanded Access Program
- Data Monitoring Committee (DMC) Charter
- ECG Simulator (Fluke ProSim 4) Usage
- EUDAMED Clinical Investigation Registration
- Electrical Performance: SNR, CMRR, Noise Floor
- FDA IDE (Investigational Device Exemption)
- GLP Compliance for Preclinical Studies
- Global Market Regulatory Strategy Alignment
- Good Clinical Practice (GCP) Guidelines
- Health Economics and Outcomes Research (HEOR)
- Home-Use Study Protocol (IEC 60601-1-11)
- Informed Consent Process and Document
- Institutional Review Board (IRB) Ethics Committee
- Measurement System Analysis: Gage R&R
- Meta-Analysis for Clinical Evidence
- Phantom Test: Ultrasound and MRI Tissue Phantom
- Post-Market Clinical Investigation Design
- Preclinical Animal Study Design: GLP Requirements
- Randomization and Blinding Strategies
- Real-World Evidence (RWE) Study Design
- Registry-Based Post-Market Studies
- Regulatory Compliance Lab (ISO 17025)
- Regulatory Submission of Clinical Data
- Sample Size Calculation: Power and Effect Size
- Systematic Literature Review for Clinical Eval
- Wireless Connectivity Testing: BLE, Wi-Fi, NFC
Distinguished Engineer· 39
- 12-Lead ECG AI Classification (DeepMind, AliveCor)
- AI Bias: Gender and Ethnicity in Medical Devices
- AI-Enabled Drug Discovery Interface
- Algorithm Transparency and Model Card
- Arrhythmia Detection with CNN (Physionet)
- CGM AI Calibration and Glucose Prediction
- Chest X-Ray AI (CheXNet, CheXpert)
- Clinical Decision Support System (CDSS) Integration
- Clinical NLP: ICD Coding and EHR Summarization
- Continuous Glucose Monitor AI Algorithm Design
- Convergence: Genomics + Imaging + AI
- DICOM Standard: SOP Classes, IOD
- Differential Privacy for Health Data
- Digital Therapeutics (DTx) Regulation
- ECG Denoising with Deep Learning (U-Net)
- EHR Integration: Epic, Cerner, Allscripts APIs
- EU MDR Annex XIV Clinical Evidence for AI
- Explainable AI (XAI) for Clinical Decision Support
- FDA AI/ML-Based SaMD Action Plan
- Federated Learning for Clinical AI Privacy
- Foundation Model for Medical AI (Med-PaLM 2)
- GDPR Article 9: Special Category Health Data
- HIPAA PHI De-Identification Methods
- HL7 FHIR R4 API for Medical Data Exchange
- Human Augmentation: Exoskeleton and Neuroprosthetics
- IoT Medical Device Security (FDA 2023)
- MRI Brain Segmentation (FreeSurfer, nnU-Net)
- PPG-Based Blood Pressure Estimation (AI)
- Pathology AI: Whole Slide Image Analysis
- Precision Medicine Platform Architecture
- Predetermined Change Control Plan (PCCP) for AI
- Quantum Sensing for Medical Diagnostics
- Remote Patient Monitoring (RPM) Platform Design
- Retinal Image Classification (Diabetic Retinopathy)
- Sepsis Early Warning Algorithm
- Software as a Medical Device (SaMD): FDA Categories
- Synthetic Clinical Data Generation for AI Training
- Telemedicine Platform Architecture
- Wearable Medical App FDA 510(k) Strategy