Workmanship

We are seasoned professionals

building effective compliance programs and submissions

for medical device manufacturers.

We believe a medical device is only valuable when it's available.  And like you, we feel the urgency to place safe and effective medical devices in markets around the world and keep them there.​

MedTech Review delivers results

Our team covers a wide range of services to meet your medical device submission, regulatory compliance, and quality management system needs. We specialize in helping our clients save both time and money. 

Reliability

Results Oriented 

Satisfaction

Submissions and Compliance

Global Medical Device Consultants

Contact us

Services

• Quality Management Systems
  
• Audits: GMP (21 CFR 820), ISO 13485:2016, MDSAP audits, Mock FDA, Mock EU-MDR, GAP Analysis, Quality Planning (ISO 10005)
  
• Corrective and Preventive Actions; Managing FDA 483s or Warning Letters
  
• Global Product Registrations (e.g., 510k/De Novo eSTAR, Health Canada, EU Notified Body, CSDT, etc.)
  
• electronic MDR Agent (21 CFR 803)
  
• US Agent
  
• MDSAP, ISO 13485, CE Marking certifications
  
• EU-MDR / EU-IVDR
• EU Technical Documentation, GSPR, Risk Management Files (ISO 14971), Usability Engineering Files (IEC 62366), Software (IEC 62304), Design Reviews (IEC 61160)