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Medical Device Quality and Regulatory Consulting

Quality and Regulatory Services

Let Orchid be your quality partner and regulatory expert. Our team provides hands-on abilities, experience and guidance. We have a proven track record with over 150 medical device and healthcare product companies. We are dedicated to providing high quality, practical and efficient solutions.

Regulatory Services
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 U.S. designated agent for foreign manufacturers  
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 Premarket 510 (k) notifications and PMA submissions  
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 Establishment registration and device listing  
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 CE marking / European MDD compliance  
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 Canadian medical device compliance / licensing  
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 Recall management / adverse event reporting  
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 Regulatory strategy  
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 Liaison with regulatory agencies including FDA  
     

Quality Consulting Services
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 Quality system development (ISO 13485 / ISO 9001 / FDA QSR)  
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 Process validation  
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 Risk management  
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 Personnel training / Auditor training  
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 Technical writing (procedures / manuals)  
     

Auditing
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 Internal audits  
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 Mock FDA inspection  
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 Supplier quality assurance including supplier auditing  
     

Team Certifications
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 Certified Quality Auditors (CQA)  
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 Certified Lead Assesors (RAB/ANAB)  
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 Regulatory Affairs Certification (RAC)  

Download Quality & Regulatory Brochure (PDF)

 

  
 
 
 
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