Medical DeviceQualified Supplier Directory

Invetech

9980 Huennekens St., Ste. 140
San Diego, 
CA us
Tel: 858/768-3232
Fax: 858/768-3299


Invetech provides instrument development and manufacturing services, delivering market leading first-of-kind instruments for diagnostics, medical devices, life sciences, drug discovery and pharmaceutical companies—collaborative, fast, innovative and systematic.

We work with you to deliver innovative clinical diagnostics solutions ranging from intelligent custom consumables to complex automated instrumentation.

Our contract manufacturing capability specializes in new and complex instruments with a focus on product support and the implementation of cost-reduction strategies.

Our team of in-house engineers, scientists and manufacturing specialists combine high-calibre technical and business consulting across the full journey, from idea to market, so our clients can be confident of achieving a successful commercial outcome.

Design, Engineering & Contract Manufacturing

Contract development services for:

  • Clinical In-vitro Diagnostic Instruments
  • Immunoassay and Clinical Chemistry Analyzers
  • Molecular Diagnostics
  • Drug Discovery
  • Medical Devices
  • Custom automation for research and production

Contract manufacturing for biomedical instruments & devices:

  • Wide-range scale & expertise in re-design for manufacturing & cost analysis, and
  • Manufacturing flexibility across facilities in San Diego, Melbourne (Australia), Shanghai (China) & Singapore.

Our involvement may include:

  • System definition, design and development,
  • process automation and optimization,
  • equipment development,
  • production scale-up,
  • contract manufacturing, &
  • sustaining engineering.

Expertise

  • Structured innovation processes to develop breakthrough ideas.
  • Proven system definition techniques to achieve market success and manage commercial trade-offs.
  • Project Management and systems engineering methodology to manage complex developments.
  • In-house specialists including industrial designers, software, mechanical & electronics engineers, chemists, physicists, scientists and manufacturers.
  • Rigorous application of reliability engineering principles.
  • Industrial design & human factors engineering for ease of use and user error reduction.
  • Fully automated assay techniques including chemistry, immuno, molecular and cellular systems.
  • Consumables design & manufacturing technology from reagent packaging to complex microfluidics devices.
  • Automatic handling & assembly of a wide range of consumables (slides, tubes, racks etc.).
  • Sample analysis, inspection & quality control through advanced optical and electrical techniques.
  • Flexible and scaleable manufacturing.
  • Metrics driven manufacturing & cost analysis using Lean Manufacturing, Kanban & Kaizen methodologies.
  • Proactive product life cycle management to reduce risk, lower costs and increase reliability.

Regulatory Compliances

  • ISO 13485:2003  & ISO 9001:2008 certified production facility.
  • Software development based on IEC 62304, classes A, B and C.
  • Experienced in design for CLIA Waiver.
  • Experience with regulatory class I, II, and III devices.
  • Experienced in current EU directives for IVD devices & MDD devices requiring the CE Mark.

Additional Offices

495 Blackburn Rd.
Mt Waverley (Melbourne), 3149  Australia
Tel: +61 3 9211 7700
Fax: +61 3 9211 7703
Industriestrasse 25
Volketswil, 8604  Switzerland
Tel: +41 44 536 1311
Fax: +41 44 536 0412