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Quality

System Audits

Performing third party quality audits

Design & Development

Blue sky concept generation, design history file creation and transfer to manufacturing

Performance

Testing

Protocol development and documentation, dimensional

analysis, flow and 

tensile testing, accelerated aging

Regulatory Clearence

Prepare FDA 510(k) premarket clearance and CE mark files.

Utilize our ISO 13485:2016 and

9001 certified quality systems

Remediation

Root cause analysis, gap assessment and quality audit correction

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The Development Process:

Project Initiation and Planning

  • Marketing Requirements Specification

  • Design Requirements Specification

  • Design and Development Plans

Prototype Development and Testing

  • Risk Assessment

  • Prototype Design and Build

  • Developmental Testing

Design, Development

and Testing

  • Design Refinement

  • Write Test Plan and Protocols

  • Developmental Testing

Validation Testing

  • Perform Usability and Clinical Testing, if required

  • Write Test Reports

Transfer to Manufacturing
MORE

Tell people what you do and give them a reason to click.

  • Perform IQ, OQ, PQ.

  • Train Operators to Work Instructions

  • Finalize DHF

Post Market Surveillance
Post Market Surveilance
MORE

Tell people what you do and give them a reason to click.

  • Review and Monitor Complaints

  • Monitor Quality Metrics

  • Update DHF as Needed

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