Medical devices are subject to strict performance and safety requirements, leading to potentially high development costs. A broad market presence can help compensate for this high initial investment. One of the greatest challenges for the industry, however, is the diversity and complexity of regulatory systems in different countries.
Internationally oriented market strategies for medical devices
We can work together with you to develop the best market entry strategy for your medical devices in your target markets:
- For conformity assessments, we help you design your tests and studies to ensure broad international acceptance.
- We maintain an overview of developments in potential markets for your medical devices to help you recognise potential regulatory hurdles in advance and get your products and documents fit for future challenges.
- We develop strategies for cost-efficient market access for your medical devices.
Safety and cost efficiency
Cultural and language barriers, combined with a lack of experience in dealing with national authorities in target countries, can make market entry a real challenge. But SCC can help you.
Backed up by our international network of experienced partners, we pave the way for a smooth regulatory process in various fast-growing markets with our portfolio of services:
- Communicating with national authorities in target countries on behalf of customers
- Providing technical translation services
- Staying on guard to protect customers’ sensitive data by ensuring that only registration-relevant information is shared with the respective authorities in target countries
- Keeping our customers up-to-date, giving them necessary insights to ensure compliance with the latest regulatory developments in target countries
We support our medical device customers in the following markets:
- North America (USA, Canada)
- Latin America (Mexico, Columbia, Peru, Brazil, Chile, Argentina)
- Asia (India, China, Japan)
- Australia, Oceania
- Further countries on request
Your benefit: SCC experts facilitate your access to new markets
Take advantage of our experience for a cost-efficient market launch in your target countries. Get in touch with our experts for international approvals now.