How verification and validation accelerate your development process

Your aim as a manufacturer of medical devices is a quick development process resulting in a shorter time-to-market. Timely planning of design verification gives you the decisive time advantage and reduces development costs.

When it comes to the testing of electronics, the characterization of sensors, or the mechanical stability check of medical devices we are your experienced partner. An early planning and accurate integration of our measuring equipment and test stations into the course of your project is decisive for the efficiency of your entire development process. And our programmable robot saves you time and money. Together we develop a verification strategy that taps the full potential of your development process.

The validation of production processes, including the validation of software used in these processes, is an essential and critical element for the safety and operability of medical devices. Production facilities and production areas must be specified, designed, set up, and tested accordingly during planning and construction to ensure that the desired product quality is reproducible in manufacturing. We are happy to support you with the following services.

Verification: how we help you reduce your development costs and time-to-market

  • Verification planning based on specifications and risk analysis,
  • Defining the test specification,
  • Planning, executing, and evaluating in vitro studies and tests,
  • Conducting inspections for verifying the product specifications,
  • Validating measuring and test stations incl. software verification/validation,
  • Validating medical devices incl. software verification/validation.

Verification may quickly become time and cost-intensive. Through the strategic coordination of Development and Regulatory Affairs paired with smart automation we realize the ideal solution.
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Design verification:
from the short end of the stick to an efficient component in your development process

Delays in the development process come with time pressure, extra work and additional costs. All the more annoying when it becomes clear that it would have been an easy task to avoid the delay. Plan your capacities for design verification at an early stage!

Your advantage: faster, safer, more flexible!

  • Test equipment and test specifications are available to you in due time.
  • The resources required for in-development testing are known.
  • We develop reliable automated test equipment for you for in-development tests.
  • With us you have access to different accredited test laboratories.

The verification process at a glance

timetable verification

Our contribution to the validation of your devices:
safety and functionality guaranteed

  • Process validation,
  • Design qualification (DQ),
  • Installation qualification (IQ),
  • Operational qualification (OQ),
  • Performance qualification (PQ),
  • Process software.

Our QM team is happy to contribute its share that all of your production processes comply with all QM requirements.
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What are you interested in?

Stay successful in the medical device market – with our whitepaper series on adapting to the MDR

Act now and ensure that your technical documentation complies with the requirements of Regulation (EU) 2017/745 (MDR). Only then can you guarantee the safety, quality, and effectiveness of your medical devices in the EU. Our whitepaper series provides you with valuable best practices for adapting your existing products to the regulation that has been in place since 2017. Start today with Part 1: "Conversion of Your Existing Products" and secure a successful future in the medical device market!

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