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, animal testing, clinical trials), reviewing results and supporting regulatory submissions.

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

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

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