Consulting for product development, approval (MDR/FDA) and market entry of medical devices
markets and more – Yvonne Julia Metzger
Hamburg · Bonn · MumbaiNew on Amplifa
About markets and more
markets and more is a consulting company for Medical Project & Quality Management based in Hamburg. The company supports medical technology companies in product development, technical development, bioengineering, Regulatory & Medical Affairs, and the approval of medical devices under MDR and FDA. Additional services include project management, marketing, market analysis and business development/sales, as well as interim management and strategic consulting. For non-European companies, markets and more serves as a gateway to entering the EU market. Owner Yvonne Julia Metzger has more than 10 years of industry experience in Germany and abroad, with several years of work focused primarily in India and the Netherlands. The company works for German, European and Indian companies, associations and institutions; alongside Hamburg and Bonn, there is a key contact in Mumbai.
- Site
- Hamburg
- Processes
- Product development, Approval of medical devices (MDR/FDA), Regulatory & Medical Affairs, Project Management, Technical development, Bioengineering, Product development for medical devices, Approval (MDR, FDA)
- Materials
- Regulatory Affairs (MDR), Regulatory Affairs (FDA), Technical Development / Bioengineering, Project Management
- Industries
- Medical technology, Healthcare market, Pharmaceutical industry, IT, Education, Office services
- 01
Market analysis
- 02
Product development / Technical development
- 03
Regulatory & Medical Affairs
- 04
Approval (MDR/FDA)
- 05
EU market entry / Business development
Service Areas
Regulatory Affairs (MDR)
Structured preparation and support of medical device approval under the MDR.
Regulatory Affairs (FDA)
Support with FDA approval for the US market.
Technical Development / Bioengineering
Product development and bioengineering for medical devices, in part with specialized partners.
Project Management
Clearly structured project management for medical technology projects.
Locations
Hamburg
DECompany headquarters
Bonn
DECompany headquarters
Mumbai
INKey contact (focus India)
Inside the production
Industries
Processes & technical limits
| Processes | Tolerance | Max. part | Weight | Lot size | Materials |
|---|---|---|---|---|---|
| Product developmentEngineering | – | – | – | – | – |
| Approval of medical devices (MDR/FDA)Engineering | – | – | – | – | – |
| Regulatory & Medical AffairsEngineering | – | – | – | – | – |
| Project ManagementEngineering | – | – | – | – | – |
| Technical developmentEngineering | – | – | – | – | – |
| BioengineeringEngineering | – | – | – | – | – |
Additional services
Background
More than 10 years of industry experience in Germany and abroad, with several years of work focused primarily in India and the Netherlands.