Medical Device Product Development Services

Experts Design Manufacturing provides specialized Medical Device Product Development Services for the creation and engineering of cutting-edge medical electronics.

Serving clients across regions such as China, Europe, the USA, Canada, and Australia, we design healthcare devices that adhere to the highest standards of performance, safety, and reliability in the industry.

Common Products for Medical Device Development and Manufacturing Services

Electronic Medical Device

Diagnostic Devices

  • ECG Monitors (Electrocardiogram)
  • Blood Glucose Monitors
  • Digital Stethoscopes
  • Portable Ultrasound Devices
  • EEG (Electroencephalogram) Devices

Therapeutic Devices

  • Insulin Pumps
  • Neurostimulators
  • CPAP/BiPAP Machines
  • TENS (Transcutaneous Electrical Nerve Stimulation) Units
  • Pacemakers/Defibrillators

Monitoring Devices

  • Wearable Blood Pressure Monitors
  • Pulse Oximeters
  • Remote Patient Monitoring Systems
  • Implantable Cardiac Monitors
  • Continuous Glucose Monitors (CGM)

Surgical Devices

  • Robotic Surgical Tools
  • Electrosurgical Generators
  • Smart Surgical Instruments
  • Endoscopic Imaging Systems

Rehabilitation Devices

  • Electronic Prosthetics with Sensory Feedback
  • Exoskeletons for Mobility Assistance
  • Functional Electrical Stimulation (FES) Devices
  • Rehabilitation Robotics

Home Care Devices

  • Smart Medication Dispensers
  • Portable Oxygen Concentrators
  • Electronic Fall Detectors

Non Electronic Medical Device or Equipment

  1. Surgical Instruments

    • Scalpels
    • Forceps
    • Scissors
    • Clamps
    • Retractors

  2. Needles and Syringes

    • Hypodermic Needles
    • Insulin Syringes
    • Blood Collection Needles

  3. Bandages and Dressings

    • Gauze Pads
    • Adhesive Bandages
    • Surgical Dressings
    • Compression Bandages

  4. Catheters

    • Urinary Catheters
    • Intravenous (IV) Catheters
    • Central Venous Catheters (CVC)

  5. Stethoscopes

    • Acoustic Stethoscopes (non-digital)

  6. Manual Blood Pressure Cuffs (Sphygmomanometers)

    • Aneroid Blood Pressure Monitors
  7. Orthopedic Devices
    • Crutches
    • Walkers
    • Braces (knee, wrist, back)
    • Slings
  8. Inhalers (Non-electronic)
    • Metered Dose Inhalers (MDIs)
    • Dry Powder Inhalers (DPIs)
  9. Wound Care Supplies
    • Sterile Gloves
    • Gauze Rolls
    • Cotton Balls
    • Hydrogel Dressings
  10. Surgical Sutures and Staples
  • Absorbable Sutures
  • Non-absorbable Sutures
  • Surgical Staples
  1. Thermometers (Non-digital)
  • Mercury Thermometers
  • Liquid-in-glass Thermometers
  1. Diagnostic Strips
  • Urine Test Strips
  • Blood Glucose Test Strips (manual)
  1. Non-electric Wheelchairs
  • Manual Wheelchairs
  1. Plasters and Adhesives
  • Medical Tape
  • Plaster Strips
  1. Splints
  • Finger Splints
  • Leg Splints
  1. Surgical Drapes and Gowns
  • Disposable Surgical Gowns
  • Sterile Drapes

Medical Supplies

  1. Personal Protective Equipment (PPE)
    • Face Masks (non-electronic)
    • Surgical Caps
    • N95 Respirators
    • Protective Gowns
    • Face Shields
  2. Sterilization Supplies
    • Autoclave Pouches
    • Sterilization Wraps
    • Disinfectant Solutions
  3. Gloves
    • Latex Gloves
    • Nitrile Gloves
    • Vinyl Gloves
  4. IV Fluids and Administration Sets
    • Saline Bags
    • IV Drip Sets
    • IV Cannulas
  5. Specimen Collection Supplies
    • Urine Cups
    • Swabs
    • Blood Collection Tubes
  6. Wound Irrigation Kits
    • Saline Syringes
    • Sterile Water Bottles
  7. Hot/Cold Therapy Products
    • Ice Packs
    • Heating Pads (non-electric)
  8. Patient Care Items
    • Bedpans
    • Urinals
    • Absorbent Pads
  9. Tubes and Drains
    • Nasogastric Tubes
    • Chest Drains
    • Drainage Bags
  10. Surgical Sponges
    • Absorbent Sponges
    • Surgical Cotton Swabs

Key Standards and Norms for Medical Device Development

  • ISO 13485:2016 – Medical Devices – Quality Management Systems
  • ISO 14971:2019 – Application of Risk Management for Medical Devices
  • ISO 60601-1:2012 – Medical Electrical Equipment – Basic Safety and Performance Requirements
  • IEC 60601-1-2:2014 – Electromagnetic Compatibility (EMC) Requirements
  • IEC 62304:2006 – Medical Device Software Life Cycle Processes
  • ISO 62366-1:2015 – Usability Engineering for Medical Devices
  • ISO 15223-1:2016 – Symbols for Use with Medical Device Labels
  • 21 CFR Part 820 – FDA Quality System Regulation (QSR)
  • 21 CFR Part 807 – Establishment Registration and Device Listing
  • 21 CFR Part 11 – Electronic Records and Signatures
  • 21 CFR Part 803 – Medical Device Reporting (MDR)
  • EU MDR 2017/745 – Medical Device Regulation
  • IEEE 11073 Series – Medical/Health Device Communication Standards
  • IEC 80001-1:2010 – Risk Management for IT Networks in Medical Devices
  • ISO/TR 20416:2020 – Post-market Surveillance for Manufacturers
  • RoHS – Restriction of Hazardous Substances
  • REACH – Regulation of Chemicals in Devices

Common Challenges in Medical Device Development

  1. Regulatory Compliance
    • Dealing with Complex Regulations
    • Adapting to Evolving Standards
    • Lengthy Approval Procedures
    • Entering Global Markets
  2. Design and Innovation
    • Designing for Safety
    • Ensuring Electromagnetic Compatibility (EMC)
    • Balancing Innovation with Risk
    • Miniaturization of Devices
  3. Risk Management and Testing
    • Managing Clinical Risks
    • Comprehensive Device Testing
    • Human Factors and Usability Considerations
  4. Software and Cybersecurity
    • Ensuring Software Validation
    • Addressing Cybersecurity Risks
    • Managing Software Updates and Patches
  5. Supply Chain and Manufacturing
    • Sourcing High-Quality Components
    • Supply Chain Risks
    • Manufacturing Process Validation
    • Cleanroom Production Requirements
  6. Time and Cost Management
    • Managing High Development Costs
    • Time-to-Market Pressures
    • Iterative Development Cycles
  7. Clinical Validation and Trials
    • Recruiting for Clinical Trials
    • Data Collection and Ethical Concerns
  8. Post-Market Surveillance
    • Monitoring Device Performance
    • Managing Field Updates
    • Ensuring Compliance with Changing Regulations
  9. Intellectual Property and Legal
    • Protecting Intellectual Property (IP)
    • Managing Product Liability Risks
  10. Interoperability and Integration
    • Ensuring Device Interoperability
    • Managing Data Standards and Integration

Our Services for Medical Device Product Development

  • Custom Feasibility Studies for Electronic Medical Devices
  • Custom Electronic Medical Device Design
  • Prototyping and Testing of Electronic Medical Devices
  • Support for Testing and Certification of Medical Devices
  • Electronic Medical Device Prototyping
  • Industrialization of Electronic Medical Devices

Our Services for Medical Device Manufacturing Support

  • Sourcing Suppliers for Medical Device Manufacturing
  • Supply Chain Management for Electronic Medical Devices
  • Vendor Coordination for Medical Device Production
  • Support for Medical Device Manufacturing
  • Quality Management for Medical Device Manufacturing
  • Setting Up Test Benches for Medical Device Testing