Design Solutions Inc.
  • Engineering Services
    • Medical Device Design & Product Engineering
    • Electronic Design
    • Software Development
    • MECHANICAL DESIGN
    • Design Verification
    • Regulatory Compliance
  • Benefits
    • Engineering Design Process
    • Medtech Expertise
  • Case Studies
    • Sleep Apnea Screener
    • Contrast Injector System
    • Wireless Event Recorder Device
    • Orbital Athrectomy System
    • Peripheral Artery Disease Measurement System
    • Intra-Compartmental Pressure Monitoring Device
    • First Responder Vital Signs Monitor
    • Impedance Cardiography (ICG) Monitor – Case Study
    • Oximetry Analysis Software System
  • About Us
    • Management Team
    • News
    • Events
  • Contact
  • Get Started
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MEDICAL DEVICE REGULATORY COMPLIANCE ASSESSMENT

Regulatory Compliance is a necessary part of medical product design. We can assist you in gaining the necessary regulatory approvals for your medical product.​ Additionally, we routinely conducts full pre-submission reviews of products to the IEC 60601 and IEC 61010 standards. These reviews help to ensure full awareness of any deficiencies prior to a regulatory submission. Design Solutions can also address design deficiencies and walk clients through formal agency testing at a certified laboratory.  

REGULATORY Compliance technical skill set

  • Evaluation and mitigation of design risks
  • EMC compliance
  • Safety compliance (IEC 60601)
  • Software gap analysis (IEC 62304)
  • Failure analysis
  • Creation of supporting documentation for FDA 510(k) submissions
View Case Studies

Our Services

A collaborative team partnership

We take pride in our extensive range of services to our clients. Our ISO 13485:2016 certified engineering design process assures our customers that we can fulfill their needs at every level of the medical device design and development process.
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DSI is a great company to work with!

- Director of Operations and Quality
SERVICES
 Product Design
 Software
 Electrical
 Mechanical
 Verification
 Compliance
BENEFITS
​ Design
 Expertise
 ISO Certified
 CASE STUDIES
ABOUT
 Meet the Team
 News
 Events
 Contact Us
GET STARTED
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  • Engineering Services
    • Medical Device Design & Product Engineering
    • Electronic Design
    • Software Development
    • MECHANICAL DESIGN
    • Design Verification
    • Regulatory Compliance
  • Benefits
    • Engineering Design Process
    • Medtech Expertise
  • Case Studies
    • Sleep Apnea Screener
    • Contrast Injector System
    • Wireless Event Recorder Device
    • Orbital Athrectomy System
    • Peripheral Artery Disease Measurement System
    • Intra-Compartmental Pressure Monitoring Device
    • First Responder Vital Signs Monitor
    • Impedance Cardiography (ICG) Monitor – Case Study
    • Oximetry Analysis Software System
  • About Us
    • Management Team
    • News
    • Events
  • Contact
  • Get Started