Global Regulatory MedDev is a leading MedTech service provider on a global scale, we are dedicated to streamlining compliance and ensuring market success. Our extensive expertise and industry insights empower us to offer tailored solutions that accelerate the entire product lifecycle for Medical Devices, Combination Products, and In Vitro Diagnostic (IVD) companies. From initial concept to commercialization and post-market support, we are committed to delivering end-to-end solutions. Our primary focus areas encompass the complete Medical Devices product lifecycle:

1. QMS Medical Device Audits: We conduct audits in compliance with FDA QSR/QMSR, MDSAP, ISO 13485:2016, and EU regulations (2017/745 and 2017/746).

2. Consulting Services for EU MDR & IVDR: Our expertise supports companies navigating the complexities of EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR).

3. Gap Assessments: We perform assessments aligned with EU MDR & IVDR requirements.

4. EU MDR/IVDR Procedures and Templates: We develop customized procedures and templates.

5. Clinical Evidence & PMCF Strategies: Crafting MDR and IVDR document remediation plans and timelines.

6. FDA and Notified Body Response Remediation: Implementing strategies to address responses from the FDA and Notified Bodie Audits.

7. Technical Documentation Plans and Reports: Our experts develop comprehensive technical documentation for the EU Medical Devices Regulation (EU MDR & EU IVDR). Additionally, we create regulatory strategic plans and reports, which are crucial for demonstrating safety and performance.