Capabilities
Capabilities
Eight capability areas for the European business of Japanese medical-device companies, delivered with specialists across Europe.
What support does DS4 provide?
DS4 supports EU market entry, regulatory affairs, quality / QMS, clinical evidence, sales and marketing, European operations and organisation building for Japanese medical-device companies — covering clinical and commercial work as well as regulatory affairs.
EU Market Entry
EU market entry
Requirements and considerations for entering the European market, aligned with the product and business plan.
- Entry requirements
- Target countries
- Entry planning
Regulatory
Regulatory
EU MDR / IVDR compliance support, including questions on EU regulatory roles such as the Authorized Representative.
- EU MDR / IVDR
- Authorized Representative
- EUDAMED
Quality / QMS
Quality / QMS
Quality management systems aligned with ISO 13485 and EU MDR.
- QMS set-up and operation
- ISO 13485
- Audits
Clinical & Evidence
Clinical & evidence
Clinical investigations, literature reviews and clinical evaluation reports.
- Clinical investigation support
- Literature review
- Clinical evaluation report
Sales & Marketing
Sales & marketing
Sales and marketing set-up with specialists in each European market, according to the product and target markets.
- Sales
- Marketing
- Market access
European Operations
European operations
Import, logistics and the day-to-day running of a European business.
- Importer
- Logistics
- Operations
European Specialist Network
European specialist network
Hands-on collaboration with specialists across Europe in regulatory, quality, clinical, sales and marketing.
- Country specialists
- Cross-disciplinary work
Organization / Internalization
Organisation & internalisation
European entity considerations, local hiring and preparation for in-house operation.
- EU entity
- Local hiring
- Internalisation
FAQ
Does DS4 support sales and marketing?
Yes. DS4 works with specialists in each European market to set up sales and marketing, according to the product and target markets.
Can DS4 support clinical evaluation reports and literature reviews?
Yes, as part of the clinical & evidence capability.
Does DS4 provide IP services?
No. European IP matters are handled with external European specialists.
Not sure which capabilities apply?
We identify the relevant capability areas together.