BENEFITS
Medical Device Regulations
We’re your dedicated partner who will help you navigate the complex regulatory landscape of the Medical Devices industry. Leverage our expertise to overcome regulatory complexities and successfully introduce your innovations to global markets. Choose your country & specialty from below to navigate and understand the local regulations.
Navigating Global Product Registration Regulations and Requirements
To ensure patient safety, every country has its specific product registration regulations. These may include:
- Technical Documentation: Manuals, product specifications, clinical evaluations, and risk analyses.
- Quality Management System (QMS): Evidence that your company’s QMS adheres to international standards.
- Preclinical and Clinical Trials Data: Proof that the device is safe and effective for use.
At Taevas, we are familiar with these regulations and will guide you through them meticulously, be it FDA’s 510(k) submission in the U.S., CE marking process in Europe, or CFDA registration in China, among others.
Taevas' Expertise in the Medical Devices Market
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Medical Devices Companies Launched
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Case Studies
BENEFITS
The Taevas Advantage
Choosing Taevas means choosing a partner who's as dedicated to your success as you are.
Local Advantage
We've got the world covered. We know how the game is played globally and have made friends in over 19 countries. We use this knowledge and these connections to help you succeed locally.
Tailored Solutions
We believe in tailor-made, not off-the-rack. We're all about crafting strategies that fit snugly with your business goals and that can move with market trends.
360°Custodianship
From product registration to marketing and distribution, we're your steadfast ally. We accompany you at each stage of the journey.
Demonstrated Success
We've helped 27+ others make it in the medical device market - and we can do the same for you.
Frequently Asked Questions
What is your experience with expanding medical device companies internationally?
We have over 5 years of experience in facilitating international expansion for medical device companies. We’ve worked with businesses of all sizes, from startups to established multinational corporations
Can you share some case studies or examples of successful projects in our industry?
Absolutely. We helped a startup medical device company enter the European and Asian markets successfully. They’ve seen a sales increase of over 200% in the first two years after expansion. Refer to our case studies here.
Do you have a specific methodology or approach for international expansion? If so, could you please describe it?
Our methodology involves thorough market research, regulatory compliance review, competitive analysis, and the creation of tailored marketing and distribution strategies for each target market.
How do you conduct market research to identify potential new markets?
We employ several market research techniques including data analysis, surveys, focus groups, and partnership with local agencies in the target market.
What are the key factors you consider when determining the feasibility of entering a new market?
Factors we consider include market size and potential, regulatory environment, cultural acceptance of the product, competitive landscape, and economic stability.
Can you assist with regulatory compliance and certifications needed for medical devices in the target countries?
Yes, we have a dedicated regulatory compliance team that can help with the certifications needed in the target countries.
contact us
Drop us a line
USA
150 College Road West, Ste 102,
Princeton New Jersey, USA - 08540