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Performance

Testing

Protocol development and documentation, dimensional analysis, flow and

tensile testing

Remediation

DHF creation and  quality audit correction

Quality

System Audits

Performing third party quality audits

Accelerated Aging

Understanding how your product breaks down over time to determine shelf life

Regulatory Clearence

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

Utilize our ISO 13485:2016 and

9001 certified quality systems

6

5

4

3

2

1

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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