Medical Device Certification -
CE Marking & FDA

Effective Product Certification for MedTech Companies

Achieving certification for medical devices is both complex and costly. Higher-risk medical products must undergo a series of rigorous tests before they can be released for sale.

MedTech companies face strict product safety regulations and must navigate numerous regulatory and compliance standards. This often leaves them feeling overwhelmed by the regulatory maze, prompting them to seek our expertise. Our comprehensive compliance management system simplifies the certification process, ensuring that MedTech companies meet all regulatory requirements efficiently and cost-effectively.

Main issues for MedTech companies

Medical device manufacturers face several significant hurdles before bringing their products to market:

Navigating a complex regulatory framework
Addressing quality control issues
Managing surprisingly high costs
Gaining access to designated Notified Bodies
Enduring extremely long certification processes

Our compliance management system is designed to help MedTech companies overcome these challenges, streamlining the path to market while ensuring compliance and reducing costs.

Our Solution for Medical Device Certification

We assist MedTech companies in navigating the complex regulatory framework and understanding product safety requirements comprehensively. Our digital approach to CE marking medical devices significantly reduces both costs and time to market. For example, manufacturers of class I devices can have their products ready for market in less than two months.

Our approach to medical device certification includes the following elements:

CE Expert guidance

We will assign you one of our CE experts to guide you through the entire CE marking certification process for your medical device. The expert will begin by reviewing your existing product development documentation, classifying your product, and performing a GAP analysis.

Digital Workshops

Our CE marking self-certification service for medical devices leverages expert guidance through web workshops and templates. After completing the GAP analysis, our expert will develop an action plan tailored to your schedule. This plan will detail the date, time, and agenda for each web workshop. You can schedule as many workshops as needed to complete the CE marking certification process, with each session lasting approximately 1 to 1.5 hours.

Complete Set of Templates

Once the action plan is finalized, we will provide you with all the necessary templates for your medical device CE marking certification under the MDD, MDR, IVDD, or IVDR. Our expert will guide you through filling out these templates via web workshops, reviewing your progress to ensure accuracy and compliance. At the end of the process, you will receive a Declaration of Conformity.

The templates include essential documents such as the risk assessment file, hazards report, quality management system documentation, classification report, verification report, Declaration of Conformity, and more.

Testing & Notified Body Assistance

For certain class I medical devices and all class II and III products, accredited testing and/or approval from an EU Notified Body is required. We offer the necessary assistance upon request.

We partner with several accredited test labs and Notified Bodies to provide conformity services for both medical hardware and software devices, ensuring your products meet all regulatory requirements efficiently.

Medical Device Certification - CE Marking & FDA