Quality & Regulatory Assurance | Certification | Verification & Validation

We help clients deliver FDA and ISO-compliant medical devices to market in a timely, cost-effective manner, with lower risk of last-minute "gotchas" and a higher predictability of success.

This can include supporting our clients through their product validation and user evaluation (field trials, clinical trials), reviewing results and supporting regulatory submissions.

Learn more about our Capabilities

Capability Highlights

  • Flexible, adaptable quality system to accommodate small startups to large multinational clients
  • Comprehensive QMS documentation
  • Fully conversant with application of IEC and ISO standards
  • Product certification
  • Regulatory approval

Our Areas of Expertise

Quality Management System Quality responsibility plan, deliverables list, adaptable templates. Follows FDA GMP guidance and ISO 13485. Comprehensive documentation that feeds Design History File (DHF), Device Master Record (DMR) and Device History Record (DHR).
Regulatory Provide technical input to client’s regulatory submission IRB and 510(k).
Compliance and Certification Design control, 62304 software process, 14971 risk management, 60601-1 certification process and relevant collateral standards: UL, NRTL, CE, CB scheme, and obtaining of Safety Mark.

Standards-based Design

Some of the design-control standards that we adhere to in our development process are as follows
Quality Management Systems, FDA, EU
  • ISO 13485 – Quality
  • ISO 14971 – Risk Management
  • EN 62304 – Software life-cycle
  • EN 62366 – Usability
  • WEE
  • RoHS
  • CA Prop 65
  • Medical Safety Design
    • Medical Safety (60601-1, 60601-1-2, 60601-1-8 etc)
    • ISO 10993 – Biological
    • ISO 11137, 35 – Sterilization
    • EN60529 – Ingress protection
    Packaging & Labeling
    • ASTM D4169 – Shipping Containers
    • ASTM D4728 – Random Vibration
    • ASTM D5276 – Drop Test
    • Various other ASTM standards
    • Sterilization
    • ISO 15223 – Symbols
    • ISO 780 – Packaging graphics
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