In Vitro Diagnostic Regulatory Affairs
Introduction
In Vitro Diagnostic Regulatory Affairs
If you’re in the business of developing and manufacturing In Vitro Diagnostic (IVD) devices, you know that regulatory compliance is a critical step on the path to market success.
Our team of experts are here to guide you through every aspect of IVD Regulatory Affairs, ensuring your devices meet the highest standards and reach the global market with confidence.
experience
Why Choose BaxMed for IVD Regulatory Affairs?
Expertise
Our team comprises seasoned professionals with extensive experience in IVD and Companion Diagnostic Regulatory Affairs, successfully navigating regulations internationally.
Tailored Solutions
We understand that each IVD device is unique. Our approach is always customised to your specific needs, whether you’re developing diagnostic assays, software or instrumentation.
Global Perspective
IVD devices have a worldwide market. We have a global perspective, keeping you informed about the latest regulatory changes in key markets, including the US, the EU, and beyond.
Services
Our Comprehensive IVD Regulatory Affairs Services Include:
Regulatory Strategy Development: We collaborate with you to create a strategic plan that outlines the regulatory pathway for your IVD device. We consider your device’s intended use, technology, and target markets to develop a tailored approach.
Pre-submission Consultation: Before you submit your IVD device for regulatory approval, we conduct thorough reviews and provide expert guidance to ensure your submission is complete and compliant.
Technical File and Design Dossier Preparation: Our team assists you in compiling the necessary documentation, including technical files and design dossiers, essential for regulatory submissions.
Quality System Implementation: We help establish and maintain quality management systems that align with IVD regulatory requirements, including ISO 13485 and 21 CFR 820, to ensure consistent device quality and compliance.
Regulatory Submission Support: From 510(k) submissions to CE Mark applications, we provide support throughout the regulatory submission process, including document preparation, liaison with regulatory authorities, and response to queries.
Post-Market Surveillance: Ensuring ongoing compliance is just as crucial as obtaining initial approvals. We assist in setting up effective post-market surveillance systems to monitor device performance and address any regulatory concerns.
Trusted
Partner with BaxMed for Regulatory Confidence
At BaxMed Regulatory Ltd, we understand that IVD Regulatory Affairs can be a complex and challenging endeavour. Our commitment is to simplify the process, allowing you to focus on innovation and delivering cutting-edge diagnostic solutions to the market.
Let BaxMed be your trusted partner on the journey to regulatory compliance and market success. Contact us today to discuss how our In Vitro Diagnostic Regulatory Affairs services can benefit your organisation and help your IVD devices reach their full potential. Together, we’ll ensure your IVD devices meet the highest standards of safety and performance, paving the way for global success.
Contact
Get in touch
Contact us today to learn more about how BaxMed Regulatory Ltd can empower your organisation to thrive in a highly regulated environment. Together, we can turn regulatory and quality challenges into opportunities for growth and innovation.