Reduce Cost of Development: primary driver of increased cost is requirement ambiguity and by setting a solid design foundation, with clear requirements will reduce effort and cost significantly. Using the correct tools and a broader understanding of requirements which should include all stakeholders will reduce time and effort and overall costs to your organization.

Regulations and Government: Your Regulatory and Quality team are key contributors to your requirement elicitation process. Using TEMPLATES and RM tools will ensure your design process follows the compliance standards.

"Since 2014, software issues have replaced device design issues as the primary cause of FDA medical device recalls."

Product Quality: Minimize your project volatility by managing changes and risks. We find that traditional requirements will not adequately address the complexity of regulations or the pace of product development.

How can we determine if your testing strategy is providing real value?

  1. Does your testing confirm the objectives of your orginal requirements?
  2. Does your testing strategy prove that your product strategy is effective?
  3. With test automation, are you testing at every single instance? It pays off!!!


Drug and medical device manufacturing relies increasingly on computerized systems. Being a highly supervised industry, to ensure quality and data accuracy Computer System Validation (CSV) is used, to ensure that critical processes are functioning properly and meet regulatory standards.

CSV is applied to many aspects of the healthcare and other regulated industries and businesses:

  1. Services
  2. Equipment
  3. Computer Systems Cleaning
  4. Processes

We offer specific services for medical device technologies in the form of: