Research & Development
Design Controls.
Embed quality into the development process—don’t wait until later to verify it. We help you establish a robust design controls process in accordance with ISO 13485 and the MDR, from user needs through to design transfer.
What design control challenges arise in medtech development?
In practice, design controls in accordance with ISO 13485 (Section 7.3) and FDA 21 CFR Part 820 are extremely often a structural weakness:
- Initial requirements (user needs) are not fully documented and cannot be fully traced back to verification and validation results at a later stage.
- The Design History File (DHF) grows organically, is often inconsistent, and is not maintained in an audit-traceable manner.
- Design reviews at milestones are merely "ticked off" as a formality, rather than serving as a genuine tool for preventing errors.
- The transfer of the design to mass production is chaotic and lacks complete qualification documentation.
Can you demonstrate complete, error-free traceability for each individual product requirement all the way through to verification?
Our Design Controls Services.
We transform design controls from a tedious "paper war" into a value-adding management tool for your R&D.
User Needs & Design Inputs
Structured identification of user needs in accordance with IEC 62366. Methodical translation of these needs into clear, verifiable design inputs. Establishment of a comprehensive traceability matrix from day one.
Design Reviews & V&V Planning
Facilitation and organization of formal design reviews (PDR, CDR, Final Review). Precise development of verification and validation plans in accordance with ISO 13485 and strict FDA requirements.
Design History File (DHF) Structure
Complete structuring and ongoing maintenance of the DHF. We ensure that all design decisions, changes, reviews, and test reports are audit-proof and ready for regulatory inspections at any time.
Design Transfer & Handover to Production
We manage the critical transition from R&D to production: defining manufacturing specifications, validating production processes, conducting initial sample inspections, and preparing formal release documentation.
Frequently Asked Questions About Design Controls.
What exactly are design controls?
Design controls are an internationally standardized, structured system for managing and fully documenting the entire product development process (ISO 13485, Section 7.3, and FDA 21 CFR 820.30). The goal: absolute assurance that the final product does exactly what it is intended to do.
What is the difference between verification and validation?
Design verification asks: "Have we designed the product correctly?" (Checking against technical specifications). Design validation asks: "Have we designed the right product?" (Checking against user needs in a real-world environment). Both are essential.
What is a Design History File (DHF)?
The DHF is the central, formal "record" of a product development process. It contains all plans, inputs, outputs, reviews, traceability matrices, and V&V results. During audits (MDR or FDA), the DHF is the very first document that inspectors examine in detail.
When should design controls be implemented in a project?
Right from the start of formal development—not just shortly before approval. Anyone who attempts to create a DHF retroactively through "reverse engineering" risks massive compliance violations, endless rework, and significant delays in time-to-market.
Related engineering topics.
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