REGULATORY AFFAIRS

Making Regulatory Affairs Comprehensive - From Idea to Market

It is difficult to navigate the medical device industry’s ever-changing regulatory landscape.  Our specialists at Key2Compliance, are well-versed in global regulations, providing specialized help for businesses of all sizes, from startups to established corporations.  
We are here to assist you throughout the product lifecycle, whether you need assistance with specific activities, a second opinion or support in your daily business. Our flexible approach allows us to work on-site or remotely, ensuring your regulatory needs are met efficiently and effectively. 

We know the requirements - and support your business in meeting them

Regulatory Strategy & Consulting

Our team excels at product qualification, risk classification, regulatory strategy, and technical documentation. 
We provide knowledge of global regulations and are always available for expert guidance and second opinions. We provide specialized consultant services, such as supporting you with the products intended purpose, similar devices, applicable standards and interpretations of regulations, standards, guidance documents and common specifications applicable to your specific device.

Product Development & Lifecycle Management

At Key2Compliance, we support you and your product throughout their entire life cycle, from concept to market, and beyond with the ever-important Post Market activities. Our expertise in medical device and IVD development ensures reliable execution and navigation of complexities. We prioritize risk management, aligning products to the highest safety standards, and our extensive risk documentation demonstrates our dedication to quality.

Design, Development & Manufacturing Procedures

Medical device design, development, and production requires meticulous processes. Our team at Key2Compliance is a specialist in efficient and compliant procedures for medical device design and development. Our guiding documents provide our clients with important knowledge and tools.

Global Market Entry & Product Registration

At Key2Compliance, we assist you with bringing safe and effective products to the market by helping you achieve CE marking for your product to access the EU market. 
We process FDA submissions, including 510k, PMA and De Novo, and support global registration of your medical device or IVD product. 
With our support, you can bring your products to market with regulatory assurance. 

Want to learn more about the road to CE-mark for your medical device?

The CE mark indicates that a product meets the applicable EU laws and allows the manufacturer to make their device available on the European market. Navigate the complexities of obtaining a CE mark for your medical device with our guide.

In this guide, you will find:

  • Detailed Overview: A comprehensive look at the CE marking process from initial concept to market entry.
  • Regulatory Framework: Insights into the Medical Devices Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR).
  • Quality Management Essentials: Steps to establish and maintain a Quality Management System (QMS) that complies with EU standards.
  • Practical Tips: Expert advice on navigating the certification efficiently to save time and avoid common pitfalls.
 

Download our guide and start your road to CE mark!

IVDR Compliance made simple

Simplify your path to In Vitro Diagnostic Regulation (IVDR) compliance. Let us guide you through the complexities of IVDR implementation, ensuring a seamless and successful compliance experience. Don’t navigate the regulatory landscape alone – Rely on us

Risk Management Introduction Package
- to get you started

ISO 14971:2019/A11:2021 has been harmonized with the EU Medical Device Regulation (MDR) 2017/745 and the EU In Vitro Medical Device Regulation (IVDR) 2017/746. 

This harmonization is important and has implications for your organization and device. How to facilitate compliance with EU regulations and to enhance patient safety. 

Rely on our experts

Navigating the complexity of regulatory requirements is not only necessary, but also a compass that will guide you on the journey to ensure that safe and effective medical devices reach those who are dependent on them, for their well-being and even their survival.”

Helena Dahlin, Director of Regulatory Affairs

Helena Dahlin

Related material

Classify your medical device with our AI powered service

Navigating the intricate landscape of regulatory affairs has never been this straightforward.

Key2Compliance presents an advanced AI-classifier, engineered to simplify the classification of your medical device. Our tool is tailored for professionals in the field seeking to transform their idea into market. 

Click below to access our free AI-classifier!
Discover your product’s classification within seconds to stay up-to-date with regulatory changes

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