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Medical Devices
At Pharma Wizard, we specialize in providing end-to-end Medical Device Regulatory Consulting and Registration Services to ensure full compliance with global standards.
Our regulatory experts support manufacturers, importers, and distributors in navigating the complex frameworks of medical device approval, certification, and post-market surveillance across multiple regions.
From device classification and technical documentation to CE marking and 510(k) submissions, we streamline every step to help bring safe, effective, and compliant medical devices to market faster.
Medical Device Regulatory Affairs
Pharma Wizard is a trusted partner for companies seeking expert support in medical device registration and regulatory compliance.
We provide tailored strategies for each productās lifecycle ā from design and development to market authorization and post-approval monitoring.
Our team has extensive experience with EU MDR (2017/745), IVDR (2017/746), US FDA 510(k), Health Canada, and SFDA frameworks. Whether your product is a diagnostic device, implant, or wearable technology, we help ensure compliance with every regulatory requirement.
Core Competencies:
- End-to-end Medical Device Registration and Submission support
- Technical File (TF) and Design Dossier (DD) preparation
- Device classification, risk assessment, and GMDN coding
- Labeling, packaging, and UDI compliance
- Regulatory strategy for CE marking, FDA clearance, and other global approvals
Navigating Regulations. Ensuring Compliance. Driving Market Success.
Digital Health / SaMD
We provide regulatory guidance for Digital Health and Software as a Medical Device (SaMD), ensuring global compliance for AI-driven and cloud-based healthcare technologies.
Market Access
Our experts simplify medical device market entry by managing submissions, pricing, and reimbursement strategies across global regions, ensuring faster commercialization.
Post Market Surveillance
We support manufacturers with Post-Market Surveillance (PMS), vigilance reporting, and periodic safety updates to ensure continuous device safety and compliance.
EU Compliance
Comprehensive support for EU MDR (2017/745) and IVDR (2017/746) compliance ā from CE marking and documentation to liaison with notified bodies and local authorities.
Quality, Compliance, & Audit
We offer GMP/GDP audit preparation, QMS development, and regulatory compliance assessments to help maintain product quality and inspection readiness.
Artwork Services
From labeling and IFU design to packaging compliance, our regulatory artwork services ensure your product information meets every regional requirement accurately.
Regulatory Affairs
End-to-end Regulatory Affairs support for device classification, technical documentation, global submissions, and regulatory lifecycle management.
Global Medical Device Regulatory Coverage
Pharma Wizard offers country-specific regulatory consulting and registration services for medical devices across the globe.
Our regional experts assist with local submissions, renewals, vigilance reporting, and licensing requirements, ensuring your productās uninterrupted market access.Ā