Case studyMedTech

Design Transfer of Combination Products from Development to Production

A medical device company developing combination products

A medical device company with combination products needed to make the design transfer from development to production more efficient while overcoming regulatory hurdles under the EU MDR and the FDA.

The challenge

The situation

Regulatory uncertainties under the EU MDR led to compliance delays, while the complexity of the FDA requirements under 21 CFR Part 4 created additional coordination needs. Limited internal resources and a lack of specialist expertise compounded the situation, and operational gaps in the transition from development to production delayed market entry through lengthy approval processes.

Our approach

What we delivered

Gap analysis to assess the design transfer and the compliance gaps

Regulatory support on the EU MDR and FDA 21 CFR Part 4

Process optimization for the transition from development to production

Cross-functional expertise to close internal resource and knowledge gaps

Implementation of modern processes for a more efficient production workflow

The outcome

Results & impact

25% faster regulatory approval

Regulatory approval was accelerated by 25 percent.

15% reduction in transfer costs

The cost of the design transfer decreased by 15 percent.

Accelerated market entry

Market entry was achieved faster than previously possible.

In summary

The market launch was successful and faster, with reduced costs, a more efficient production process, and greater competitiveness.

Regulations & standards considered

EU MDR (Regulation (EU) 2017/745)
FDA 21 CFR Part 4 (combination products)

Related expertise

Production Transfer & Scale-up →

Transition from development to production and scale-up

MDR Consulting →

Regulatory support on the EU MDR

FDA Approval Medical Devices →

FDA requirements, for example under 21 CFR Part 4

Design Controls →

Design transfer as part of design controls

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Sources

https://theentourage.de/case-study/design-transfer-kombinationprodukte/ (live case study, accessed 2026-06-14)

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