Hiemstra has introduced our state-of-the-art hiQual quality management system (QMS) which streamlines medical device design and development, from feasibility through manufacturing. This new, electronic QMS is completely digital, certified to ISO 13485:2003, and QSR compliant.
We’ve implemented this process-based QMS into all aspects of our business and have a full suite of hiQual software modules, which ensure that all of our creative and innovative medical designs meet strict design control standards during every step of the process by doing it right the first time.
Solid regulatory submission data
- Provides solid documentation for a comprehensive regulatory submission. Be it 510(k) or a PMA filing, Hiemstra’s QMS is at work from day one.
Portability for manufacturing
- Frames manufacturability in a complete, portable, digital package for seamless manufacturing transfer, whether here in the Bay Area, across the country, or offshore.
Identification of risk earlier in the venture
- Uncovers project feasibility and product development obstacles before resources and/or funding are expended.
Elimination of backfilling of documentation for quality, regulatory or manufacturing requirements
- Design for quality upfront to avoid unnecessary cost overruns and schedule delays.
- Shorten timelines by addressing the design before project deliverables go ‘critical path’.
- Satisfies requirements for medical device development via ISO-13485 and meets all Title 21 Part 820 Code of Federal Regulations.
- Licensed by the California Food and Drug Branch.
hiQual combines the creativity of design, the controlled process of a serious product developer and the agility of a start-up – all under one roof!
|
QMS