The In-Country Representative’s role is to confirm basic compliance requirements and serve as a local point of contact for authorities should there be a problem with your product. With MedEnvoy as your representative, you are one step closer to ensuring regulatory compliance, placing products on the market, and ensuring positive patient outcomes.
Your Global Partner for Medical Device Regulatory Compliance
Streamline Market Entry for Your Medical Devices with Our Regulatory Importer and In-Country Representation Services and Expert RA/QA Consulting
Our Services
In-Country Representation
Meet basic compliance requirements prior to product placement
in all European markets
Regulatory Importer
Our Regulatory Importer services ensure ongoing compliance without
disrupting your supply chain.
We perform many tasks to ensure your ongoing compliance with the EU, UK, Swiss or India regulations without the need to take title or take physical possession of your devices. Our compliance checks are done electronically and efficiently.
RA Consulting
Our team has extensive experience working with Small and Medium-Sized Enterprises (SMEs) to ensure they meet the latest regulatory requirements. We understand the budgetary constraints that many companies face, which is why we offer cost-effective services while still providing high-quality support.
QA Consulting
Implementing your QMS (or bringing your existing QMS up to standard) is a necessary step when preparing your technical documentation for CE Mark certification and extends throughout the life cycle of your device. Depending on your product classification, your Notified Body (NB) will audit your QMS as part of your conformity assessment and conduct regular audits as long as your product is on the market.
Our QMS Compliance Consulting services are tailored to guide medical device and IVD manufacturers through the intricacies of the EU MDR and IVDR, ensuring not only regulatory adherence but also enhancing overall product quality and safety. Our consultants specialize in the comprehensive development, implementation, and auditing of ISO 13485 QMSs, ensuring that your organization is well-positioned for European compliance.
MedEnvoy as Your Trusted Expert
MedEnvoy was created to offer medical device manufacturers a solution to meet compliance regulations seamlessly and efficiently with the introduction of the new European Union Medical Device Regulation (EU MDR) and the In Vitro Diagnostic Regulation (IVDR). Similar or identical requirements are required in the UK, Switzerland, US, India and Australia.
MedEnvoy is ISO 13485: 2016 certified! View our certificate.
Comprehensive Solution for Medical Device Manufacturers
MedEnvoy provides a unique solution by offering both in-country representation and regulatory importer services. These services are supported by an experienced team of regulatory affairs and quality assurance professionals.
We are the only service provider to offer this comprehensive solution, simplifying the process of bringing medical devices and IVDs to market in various countries.
Industry News and Resources
Regulatory Importer
Our Regulatory Importer services ensure ongoing compliance without
disrupting your supply chain.
We perform many tasks to ensure your ongoing compliance with market-specific regulations without the need to take title or take physical possession of your devices. Our compliance checks are done electronically and efficiently.
Our importer process does not disrupt the way you ship today.
In-Country Representative
Meet basic compliance requirements prior to product placement
in all European markets
The In-Country Representative’s role is to confirm basic compliance requirements and serve as a local point of contact for authorities should there be a problem with your product. With MedEnvoy as your representative, you are one step closer to ensuring regulatory compliance, placing products on the market, and ensuring positive patient outcomes.
Consulting
Navigating the regulatory landscape can be a complex journey, and our team is here to simplify it for you.
Our team has extensive experience working with Small and Medium-Sized Enterprises (SMEs) to ensure they meet the latest regulatory requirements in Europe and beyond. We understand the budgetary constraints that many companies face, which is why we offer cost-effective services while still providing high-quality support.
San Fransisco, California
Edgar Kasteel
Partner & CEO
René Van De Zande
Partner & CCO
Dr. Stefan Tuschen
Partner & COO
Decades of Experience
Our executive management team has been assisting medical device and IVD manufacturers with compliance for decades. Our standardized and proven processes will help you simultaneously maintain commercial control over your economic operators without disrupting the way you do business today. Meet the MedEnvoy Team.
Navigating Regulatory Landscapes Worldwide
We take pride in our proven track record of providing regulatory affairs consulting and in-country representation services to manufacturers seeking to expand their reach in various markets.
We have helped numerous clients navigate complex regulatory landscapes, streamline processes, and maintain compliance with ease. In our collection of case studies, learn how our expert regulatory team provides a comprehensive solution to the regulatory requirements.