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, animal testing, clinical trials), reviewing results and supporting regulatory submissions.
Quality & Regulatory Assurance | Certification | Verification & Validation

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

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

  • REACH

  • 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

Aproio: we analyze, design, build & test medtech and other highly regulated products