Anecto Test Services’ core competencies lie in reliability analysis and test engineering. Our multidisciplinary group of engineers and consultants have the expertise and resources to support your product and packaging development activities.

Our areas of expertise:

Packaging

Anecto has the experience and in-house capabilities to offer packaging optimization consultancy to eliminate any possible design flaws a product’s packaging may have. Our team consists of test engineers, mechanical design engineers, and mechanical engineers, with decades of experience in areas ranging from concept development to packaging remediation consultancy. All our activities will conform to our ISO 9001 certification and operate within the ISO 17025 accreditation.

Anectos’s knowledge derives from intensive experience in designing, consulting, testing and project management for the electronics and medical device sectors.

Services in this area include:

  • A range of industry training courses both standard and custom
  • Packaging reliability analysis and design
  • Test process analysis and design
  • Remedial work on existing packaging
  • Remediation and legacy product audits
  • Design verification testing
  • Product and process validation
  • In-depth research, analysis and prompt evaluations of test and inspection equipment needs
  • Customized test equipment
  • Packaging design
  • Protocol generation
  • Technical file preparation
  • Regulatory preparation and submission
  • CE marking
  • IEC 60601-1
  • Aftermarket services

Regulatory

Before a medical device can be placed on the market there are significant legal requirements with which it must comply. Our regulatory compliance resources will assist you to meet those requirements. We have the expertise to guide your product from concept development to placing the product on the market.

Test Method Validation (TMV)

Failure to maintain consistent and traceable test processes at all stages of the product lifecycle carries significant and avoidable risk.

What is a test method validation?

Test method validation is a risk-based arm of quality control designed to demonstrate the validity of a test or inspection method. Using TMV, the process under examination must show at various stages that it meets intended requirements and produces usable results.

There are a number of occasions when TMV is required:

  • Developing a new test method
  • Revising an existing test method
  • Establishing an existing test method in a new facility
  • Comparing the effectiveness of two methods

Start-up support

Anecto Test Services has the experience and resources to respond to the needs of newly formed start-ups, as well as large multinational companies. We understand that the challenges facing start-up companies can be daunting. With this in mind, our general consultancy is specifically structured to help start-up companies gain a foothold in the market. Whether a Customer requires consultancy on design or what tests a product needs to undergo, advice on any legal directives that need to be followed, Anecto can support their needs.

Electronics and Mechanical

Anecto’s highly qualified personnel have almost two decades of experience working with major electronics industries. Using Anecto’s consultancy services means a company can take advantage of our extensive knowledge in the design and development of new products in areas including:

  • Test planning and project management
  • Design For manufacturing (DFM)
  • Design for test (DFT)
  • Design For reliability (DFR)
  • Failure mode effects analysis (FMEA)
  • Weibull analysis (statistical method to determine where a population of modules are on the “bathtub” curve)
  • Failure rate analysis (extracted from MTBF calculations)
  • Determining product acceleration factors using Arrhenius, Coffin Manson, Eyring etc. methods
  • Product reliability testing
  • Product in circuit testing (ICT) and functional testing

IEC 60601 – Specific Support

Medical electrical equipment in Europe must comply with EN 60601-1 in order to conform to the legal requirements of the Medical Device Regulations. This applies to existing devices on the market and to new devices currently under development. More on IEC 60601…

Translating IEC 60601 Requirements into Results Diagram

Translating IEC 60601 Requirements into Results

Talk to Us About Our Technical Guidance Services:

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