Medical Devices Registration Services
Regulatory Strategy, Technical Documentation & Market Authorization
Get Free Device Regulatory ConsultationMedical device registration requires precise classification, robust technical documentation, and continuous regulatory compliance. At Medwisdom, we provide end-to-end medical device regulatory services to help manufacturers and distributors achieve smooth approvals and sustainable market access across global markets.
Our Medical Devices Regulatory Capabilities
Comprehensive regulatory support from classification to post-market compliance
1. Device Classification & Regulatory Strategy
- Device classification (Class A–D)
- Regulatory pathway & submission strategy
- Market-specific requirements assessment
- Gap analysis of technical documentation
2. Technical File & Design Dossier
- Technical File / Design Dossier preparation
- Essential Principles / GSPR compliance
- Risk management (ISO 14971)
- Clinical evaluation / performance reports
3. Quality Management & Manufacturing
- ISO 13485 QMS compliance support
- Manufacturing process documentation
- Supplier & critical component controls
- GMP / QMS audit readiness
4. Registration & Authority Submissions
- Medical device registration submissions
- Online portal filings (where applicable)
- Authority query & deficiency responses
- Coordination of regulatory audits
5. Labeling, UDI & IFU Compliance
- Device labeling & IFU preparation
- UDI implementation & compliance
- Language & country-specific requirements
6. Post-Market Surveillance & Lifecycle
- Post-Market Surveillance (PMS) plans
- Vigilance & adverse event reporting
- Field safety corrective actions (FSCA)
- Renewals & post-approval changes
Global Medical Device Standards We Follow
Our medical device registrations align with internationally recognized regulatory frameworks
ISO 13485
Quality management systems for medical devices
ISO 14971
Risk management for medical devices
EU MDR / IVDR
European medical device regulatory framework
SFDA / FDA / IMDRF
Global & regional medical device regulations
Why Choose Medwisdom for Medical Devices?
Trusted regulatory partner for compliant and efficient device registrations
All Device Classes Covered
Class A to Class D medical devices
Strong Technical & QMS Expertise
ISO-compliant technical documentation
Global Market Experience
SFDA, GCC, EU, US & international markets
Inspection & Audit Readiness
Prepared for regulatory and QMS audits
Vigilance & PMS Integration
Post-market safety and compliance support
Transparent Project Management
Clear timelines and predictable outcomes
Ready to Register Your Medical Device?
Partner with Medwisdom for expert-led medical device registration and compliance support.
Book Free Device Consultation