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Putting your compliance first

Quality assurance and regulatory compliance are our core values, backed by ISO standards and  FDA-compliant operations, FDA inspection, and rigorous audits, enabling you to trust in our track record for your success.
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Where quality and compliance power every build

From the initial concept phase, where the product regulatory and quality compliance requirements are defined, to engineering design, through to the final prototype. Our robust adherence to ISO 13485:2016 standards ensures compliance in all aspects of design controls and manufacturing operations
Detailed QA Documentation Tiered QMS Documentation Unrivaled Compliance Certifications

Detailed QA Documentation
With over three decades of experience, we have developed a customized, FDA-compliant automated software system, tailored to uphold stringent quality assurance processes and cater to diverse applications. Alerts notify technicians and our quality assurance team of any out-of-tolerance data, allowing for rapid identification and correction. Empowering our skilled team, the Quality Management System (QMS) enables confident navigation of regulatory requirements, ensuring compliance and surpassing your expectations.

Tiered QMS Documentation

Quality Manual (780-03001)

 

  • The highest level document
  • Auditors often ask where you can locate a copy


Quality & Departmental Procedures

 

  • Describe what is required to achieve associated QMS requirements
  • Job title will determine which procedures you require training for


Work Instructions & Forms

 

  • Further describe how applicable quality system and department activities are performed and documented


Quality Records

 

  • Lowest level documentation,but equally as important
  • Maintained to provide objective evidence of conformity and effective operation of the QMS requirements

Unrivaled Compliance Certifications
As an FDA-registered medical device manufacturer serving Class I, II, and III products, we uphold a spotless track record with no major findings throughout our history. Your confidence is our top priority.


ISO 13485
IEC 62304
Current Good Manufacturing Practices (cGMP) 
Calibration and Metrology
FDA QSR Parts 820, 803 and 806
Part 11 Compliance

Get a copy of our ISO registration

 

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From first sketch to final build, we go the distance

HiArc delivers integrated design, engineering, and manufacturing services—so you can move from idea to impact with a single, expert partner.

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Built to scale, ready to move

We manage a world-class supply chain designed for speed, control, and compliance. With an ISO 13485-certified system, robust vendor networks, and full traceability across programs, we’re able to deliver at scale without compromising quality or agility.

Expertise that ensures you’re audit-ready from day one

From design inputs to final release, HiArc embeds quality and compliance at every stage—aligning seamlessly with your regulatory path and product goals.

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