"Unlock European Markets with Our Expert Team’s Expert Regulatory Guidance"
Our expert team specializes in guiding you through the complexities of the European market, particularly focusing on compliance with EU Medical Device Regulation (MDR) (MDR 2017/745) and In Vitro Diagnostic Regulation (IVDR) (IVDR 2017/746) requirements. With deep knowledge and expertise in these regulations, we provide comprehensive support to ensure your products meet the necessary standards for market entry and regulatory approval in Europe
Our Services
Regulatory Strategy and Consultation
Provide expert guidance on regulatory pathways, submissions, and compliance strategies for CE marking acting as your Person Responsible for Regulatory Compliance.
Navigate complex regulations of EU MDR and EU IVDR.
Regulatory Submissions Support
Ensuring compliance to EU MDR and EU IVDR requirements. Prepare and review technical file for CE Marking application.
Provide support in appointing EU Authorized representative for manufacturers lacking legal presence within the European Union, for a smooth entry into the European market.
Product Classification and Labelling
Assist in product classification according to EU MDR and EU IVDR regulatory requirements.
Develop compliant product labels, Instructions for Use (IFUs), and packaging inserts as per applicable regions of European Union.
Testing Requirements and Safety Assessment
Discover the testing essentials for your device, including biological evaluation, electrical safety testings, and clinical evaluations, receiving guidance on the precise safety and performance standards best suited to its specific type.
Risk Assessment and Mitigation
Implement risk management processes based on ISO 14971. Identify, assess, and mitigate risks associated with medical devices.
Develop risk management plans to ensure product safety and regulatory compliance.
Post-Market Support
Provide support to implement processes for post-market surveillance, Post-market clinical follow-up, complaint assessments, CAPA, and Device Recalls.
Provide comprehensive review of promotional/marketing materials and website contents in compliance with regulatory requirements.
Gap Analysis
In-depth assessment of your current technical documentation, and compliance practices against the relevant regulatory standards.
Identify deficiencies in Technical Files, DMRs, DHRs, and labeling.
Develop a tailored plan to bridge gaps.
Connect With Us Now
We are eager to collaborate with you on your regulatory needs. Connect with us today for tailored solutions designed to meet your unique requirements.