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
- 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
Medical Devices Companies Launched
Months average time to market
Products available for new partnerships
Percent cost savings
The Taevas Advantage
Choosing Taevas means choosing a partner who's as dedicated to your success as you are.
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.
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.
From product registration to marketing and distribution, we're your steadfast ally. We accompany you at each stage of the journey.
We've helped 27+ others make it in the medical device market - and we can do the same for you.