Development of orthopedic implants and MedTech services from idea to market-ready product.
DesignHaus by Merete (Merete GmbH)
New on Amplifa
About DesignHaus by Merete
DesignHaus by Merete is the development and regulatory service of Merete GmbH for MedTech companies in endoprosthetics. The company supports customers as an extended development team with end-to-end implant and instrument development, preparation of technical documentation and DHF, Product Verification & Validation, and Regulatory Guidance under EU MDR and FDA. The team of engineers, quality and regulatory specialists covers risk classes I–III and develops products from simple designs to highly complex systems, including hip implants (primary and revision), foot and ankle, pediatrics, trauma and salvage. The foundation is almost 30 years of experience in developing commercially successful orthopedic implants, including the BioBall® system. DesignHaus works closely with surgeons and industry partners and emphasizes agile decision-making, short execution times and audit-proof quality management.
- Processes
- End-to-end Implant & Instrument Development, Technical Documentation & DHF Preparation, Product Verification & Validation, Regulatory Guidance (EU MDR / FDA), Orthopedic Implant Development (hip primary & revision, foot & ankle, pediatrics, trauma,, End-to-end implant and instrument development, Technical documentation & DHF preparation, Verification & Validation
- Materials
- End-to-end Implant & Instrument Development, Technical Documentation & DHF Preparation, Product Verification & Validation, Regulatory Affairs (EU MDR, FDA)
- Industries
- MedTech, Endoprosthetics/Orthopedic Implants
- 01
Product idea/concept
- 02
End-to-end implant & instrument development
- 03
Technical documentation & DHF preparation
- 04
Product Verification & Validation
- 05
Regulatory Affairs (EU MDR, FDA)
- 06
Market-ready product
Services & Competencies
End-to-end Implant & Instrument Development
Development of orthopedic implants and instruments from the initial idea to market readiness.
Technical Documentation & DHF Preparation
Establishment of audit-compliant technical documentation and Design History Files.
Product Verification & Validation
Demonstration of product requirements through structured verification and validation.
Regulatory Affairs (EU MDR, FDA)
Regulatory support for market approval in the EU and USA.
Development Areas
Industries
Processes & technical limits
| Processes | Tolerance | Max. part | Weight | Lot size | Materials |
|---|---|---|---|---|---|
| End-to-end Implant & Instrument DevelopmentEngineering | – | – | – | – | – |
| Technical Documentation & DHF PreparationEngineering | – | – | – | – | – |
| Product Verification & ValidationTesting | – | – | – | – | – |
| Regulatory Guidance (EU MDR / FDA)Engineering | – | – | – | – | – |
| Orthopedic Implant Development (hip primary & revision, foot & ankle, pediatrics, trauma,Engineering | – | – | – | – | – |
Additional services
History
- 1996
Team has been developing commercially successful orthopedic implants since 1996, including the BioBall® system
- 2026
Launch of DESIGNHAUS by merete as a dedicated development and regulatory service for MedTech companies