Development Processes & Requirements Management

Compliance with regulatory requirements doesn’t have to hinder your innovation. Quite the opposite! With the right processes and well-thought-out Requirements Management, you can achieve both: efficient development and full compliance. My services are designed to do just that: I’ll help you structure your development processes to be streamlined while meeting all requirements. I’ll support you in precisely defining, managing, and ensuring the traceability of your requirements. Let’s elevate your development process to the next level—compliant and successful.

Efficient Development Processes: The Backbone of Your Success

They bring clarity, define responsibilities, and keep regulatory pitfalls at bay. This allows you to identify bottlenecks early and ensures you’re never caught off guard at the finish line—well-prepared instead of unpleasantly surprised.

Crystal-Clear Requirements: The DNA of Your Medical Device

They are the foundation, defining what your product must achieve for enthusiastic users, safe patients, and satisfied auditors. Precise requirements not only make your product better but also testable from the outset. Because only those who know the goal can hit the bullseye!

The Right Software Tools: The Nervous System of Your Development

The right tool guides you through development, allowing for full traceability across all levels of requirements, as well as to all validation and verification activities. Without it, efficiently developing, manufacturing, or maintaining a medical device in the market is no longer possible.

How I Polish Your Development Processes:

  • Analysis & Optimization: We’ll scrutinize your workflows—where are the bottlenecks, where can things run more smoothly? This includes identifying pain points and potential improvements.
  • Adaptation to New Rules: EU-MDR/IVDR, new goals, or products? Your processes will stay fit for the future.
  • Redesign & Implementation: Tailored, lean processes that fit perfectly—with clear phases and smart decision points (Gate Reviews).
  • Risk Management (ISO 14971) as a Core Element: Fully integrated, not just for show.
  • Systematic Document & Configuration Management: For a Design History File (DHF) that is seamlessly convincing.
  • Methodological Power: V-Model, Agile (where it fits!), Stage-Gate—we’ll find and implement what drives you forward.
  • Training & Coaching: Ensuring new processes aren’t just on paper but are lived by the team.

How Your Requirements Management Will Be a Bullseye:

  • Systematic Elicitation: We’ll extract all relevant needs (User Needs, Intended Use) from all stakeholders.
  • Analysis & Specification – Clear Text Instead of Prose: “It would be nice” becomes a clear, testable “must be” for all requirement types (function, safety, usability, etc.).
  • Management & Traceability – The Red Thread: Seamless traceability from desire to test. Changes? Controlled and transparent!
  • Validation & Verification – Does It Fit and Does It Work?: We ensure requirements are correct and your product delivers on its promises.
  • Tool Support: The best tools for the job? I’ll help with selection and implementation.

The Unbeatable Duo for Your Market Success!

Strong processes need crystal-clear requirements—and vice versa. Like fries and ketchup (or mayo!), they’re unbeatable together. I ensure the perfect synergy.

Ready for a turbo-boost in your product development? Then I look forward to our conversation!

Let's work together!