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Manufacturing Quality is a
Proven Treatment for Success

with HQA360

Manufacturing Quality in the Medical Industry

Manufacture High-Quality, Innovative and Compliant Products

Medical device manufacturers face many challenges in order to manufacture innovative, high-quality goods that also comply to FDA regulations and ISO quality system requirements. Quality in the medical industry cannot completely be managed effectively with conventional document-centric quality management tools.

Processes for quality control and manufacturing are connected by HQA360’s product-centric quality management system (QMS). With one reliable source of truth, compliance to regulations is made easier, transparency is improved, and production is increased.

High QA manages quality in industries including quality in the medical industry

Industry Challenges

High QA manages quality in industries including quality in the medical industry
  • Silos of product and quality records
  • Disconnected processes in quality, engineering, and operations
  • Issues creating production controls to comply with quality system regulations
  • Problems creating and tracking product revisions
  • Serialized traceability throughout the manufacturing process

How High QA Helps

  • Unifying quality and product record management to improve control and traceability
  • Addressing quality issues earlier with preventative tools like Dynamic AQL (AOQL) sampling
  • Assuring continuous compliance with FDA Title 21 CFR Part 11 and ISO 13485
  • Decreasing audit risks by synchronizing data across all documentation
  • Improving cross-departmental communication with digital workflows
High QA manages quality in industries including quality in the medical industry

See HQA360 in Action

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Simplify and automate manufacturing quality processes with High QA software

Medical Device Customer Success

Simplify and automate manufacturing quality processes with High QA software

Paragon Medical

Our investment in High QA has enabled us to include new APQP deliverables while achieving the projected rate of return in less than six weeks.

Jeff Livingston
Sr. Quality Manager

Medical Device Companies Trust High QA

Simplify and automate manufacturing quality processes with High QA software
Simplify and automate manufacturing quality processes with High QA software
Simplify and automate manufacturing quality processes with High QA software
Simplify and automate manufacturing quality processes with High QA software
High QA customer PLansee uses High QA software to manage quality in the medical industry for precise parts

SEE HIGH QA
IN ACTION