Regulatory Services
Simplify Your Regulatory Journey With ND Global
With ND Global navigate the complexities of diverse country-specific regulations that can be daunting. At ND Global, our experienced team ensures seamless compliance with local, national, and international standards without delays.
Our experts have extensive experience with EU-MDR, USFDA, HEALTH CANADA, Swiss Medic, and other major regulations. At ND Global, we offer exceptional expertise in various areas, such as Clinical Evaluation Report (CER), Risk Management, Post – Market Surveillance (PMS), Technical Files, Gap Analysis for new market entry, UDI Preparation, and IFU Preparation for a diverse range of products.
With ND Global, you’re not just another client – you’re a partner on the journey to a hassle-free registration process that paves the way for timely market entry.
EU-MDR (EUROPEAN UNION)
On May 26, 2021, the European Union Medical Devices Regulations (EU MDR) replaced the Medical Device Directive (MDD) 93/42/EEC and the Active Implantable Medical Devices (AIMD) Directive 90/385/EEC. Suppose a company wants to sell its products in the European market. In that case, compliance with the European Medical Device Regulation (EU MDR), which governs the production, distribution, and sale of medical devices in Europe, is necessary.
ND Global supports the transition from MDD to MDR— ND Global is well-positioned to help its clients at various product development and registration stages in the European Union.
USFDA (UNITED STATES)
ND Global specializes in guiding medical device manufacturers through the intricate process of adhering to the rigorous standards of the US Food and Drug Administration (USFDA). Our expertise extends across all phases of product development and registration in the United States.
From initial design to final approval, we provide comprehensive support to ensure that your medical devices meet the stringent compliance requirements of the USFDA, enabling you to navigate the regulatory landscape confidently.
Our Regulatory Services
Regulatory Affairs (RA)
Medical Writing
Post Martket Surveillance (PMS)
Regulatory Affairs (RA)
- International Medical Device Registration Consulting: Strategy planning, Gap Assessment, Remediation.
- Pre-Submission Regulatory Support.
- Post Submission Regulatory Support.
- FDA U.S Agent Services.
- CE Marking
- UKCA
- Health Canada MDL and MDEL
- Technical File
- Biological Safety & Validation Consulting
- Premarket Notification 510 (k)
Medical Writing
- CEP and CER as per MDR, TGA, IMDRF and MEDDEV 2.7.1, Revision 4
- Appraising, Analysing and summarizing the clinical data
- Labelling, Instructions for Use (IFUs) and User Manuals
- Clinical Evidence Summaries (One-Page)
- Summary of Safety and Clinical Performance (SSCP)
- Performance Evaluation Plan and Report
- Quality, Security and Usefulness Dossier for Combination Devices
- Clinical Literature Search and Review
Post Martket Surveillance (PMS)
- PMS Procedure
- PMS Plan and PMS report
- Period Safety Update Reports (PSURs)
- PMCF Plan, PMCF Survey and Report
- CAPA
- Adverse event reporting
- Complaint handling
- Medical Device & Vigilance Reporting
Global Regulatory Services
ND Global offers regulatory planning, compliance, and submission support for different regulations, such as Health Canada (CANADA), Medicines and Healthcare Products Regulatory Agency (UNITED KINGDOM), SFDA (SAUDI ARABIA), PMDA (JAPAN), TGA (AUSTRALIA), NMPA (CHINA), ANVISA (BRAZIL), SWISSMEDIC (SWITZERLAND).
We guide clients through individual country submissions and create a single, practical regulatory strategy roadmap that considers the needs of various regulatory authorities, all while minimizing time and maximizing resource efficiency.
