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Medical Device

Anecto is an independent NSAI and INAB accredited ISO17025 test laboratory to the Medical Device industry. We provide design, test and validation services at each stage of the product life cycle from concept design right through product sustain (Validation for redesigns and Repair and Warranty services), to end of life.

With over 20 years of experience testing electronics based products, our customers include leading Device manufacturers such as Covidien, Siemens, Medtronic… to name a few. Our experienced team of engineers and technicians have a high level of knowledge on medical test protocols and standards and validation to FDA standards.

Contact us today about your Medical Device/Equipment test requirements

Anecto can offer unrivalled flexibility combined with excellent industry specific knowledge and experience of the medical device industry which will reduce your test support work load and ultimately reduce your costs.

  • Exposure  Testing: IP testing, including IPX6K, IPX9K, Salt Spray (Corrosion), Dust (IP5X, IP6X)
    • Standards include, EN60529 Water/Dust Ingress, EN60068-2-52 Salt Mist Cyclic, EN60068-2-11 Salt Mist
  • Accelerated Stress Testing:  Vibration testing (with temperature), Various Climatic tests including Controlled Temperature and humidity cycling
  • Environmental Performance Testing: Humidity, and Altitude Simulation testing, as well as Thermal Aging, Thermal Shock testing and Thermal Cycling
    • Standards include EN60068-2-1 Cold, EN60068-2-2 Hot, EN60068-2-14 Temperature Cycle/Shock, EN60068-2-78 Damp Heat Steady State, EN60068-2-30 Damp Heat Cycle, EN60068-2-38 Humidity Composite Cycle
  • Altitude Testing (Standard EN60068-2-13 Low Pressure)
  • Accelerated Stress Testing : HALT, HASS, HAST
  • Mechanical tests including Tensile testing, Drop/Impact  testing and Shock testing,
  • Vibration  Multi-axis Vibration testing, including vibration with temperature superimposed
    • EN60068-2-6 Sine Vibration, EN60068-2-64 Random Vibration, EN60068-2-27 Shock, EN60068-2-31 Drop/Topple, EN60068-2-32 Free Fall
  • Transportation testing as per ISTA and ASTM Standards.
  • EMC Emissions testing 18m x 13m ALSE, UN ECE-R10, 72/245/ECC, 2009/19/EC – Transient

Design and Consultancy Services:

  • DFX- Evaluation and guidance on design for reliability, manufacturing, test
  • Fixture design, build and associated support
  • Test automation design, build and validation
  • Reliability Prediction Analysis e.g MTBF
  • Product and process validations (IQ, OQ, PQ)

Product life cycle support:

Anecto is the partner of choice for companies designing and manufacturing Electronics based Medical products. Engaging Anecto at the very beginning of the product life cycle provides the expertise and accredited test services required to ensure your DFX design needs are fulfilled and that all requisite testing is carried out to the appropriate standards for product validation.

Importance of DFX (Design for Reliability/Test/Manufacturing) from Concept:

DFX considerations need to be taken into account from the start of the design process. This is why it is important to have easy access to all the resources you will require in terms of the expertise and equipment required for world class design for reliability, test and manufacturing. These resources can exist in-house at the OEM, but more often are outsourced to test houses and manufacturing houses that have this area as their core competency. Engaging with a manufacturer that has the following capabilities is essential:

Design for Reliability:

  • HALT has become a staple of the design process for the medical device industry. In a complicated electro-mechanical design such as a PCBA integrated into a housing with many connectors etc., the more parts there are, then the more chances there are of failure modes. Doing a HALT does 2 things
    • Highlights the mechanical weaknesses in the design which can be subsequently designed out
    • Identifies your operating and destruct limits – no other test process does this

Validation Testing:

The medical device industry, particularly when FDA approval is sought, invests a lot of money in validating designs before going into production. This is best achieved through an ISO17025 approved process, where environmental stress testing (shake and bake), and EMC testing is done to strict industry standards. If good design for reliability guidelines are followed from the beginning of the design process, then validation testing is normally a seamless process where the failure modes have already been designed out and the product passes first time. This has obvious time to market advantages as well as cost savings.

NPI and Production:

Engaging with your contract manufacturing partner at the earliest stage of the design process will ensure that the correct design for test and manufacturing considerations are implemented in the final design. This means a smooth transition through NPI into full production. HASS testing can then be implemented at the early stages of production in order to screen out manufacturing related defects and hone the process. All of this maximises product reliability and quality which will feed forward into the full life cycle.

Full Life Cycle Support:

With the long life cycle of typical medical devices and the increasing prevalence of obsolescence issues mid-lifecycle, it is imperative to have a reliable test and manufacturing partner, with the associated experience and expertise, to allow for redesign and associated validation testing to be carried out seamlessly when required through the product life.

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Case Study – Emerson Network Power

Case Study

Emerson Network Power logo

How Anecto developed a number of innovative solutions for the leading multinational Emerson Network Power.