Medical Device and Pharmaceutical Consulting

We are the global regulatory and quality system experts providing consulting services to the medical and pharmaceutical
industries.

Our mission is to deliver compliant, audit ready system documents and solutions that support new product introductions and global quality system requirements for the medical device and pharmaceutical industries.

If your new product development teams are working with a mountain of document deliverables, struggling with implementing 210/211 regulations and not sure if your product requirements and validation documents are compliant and audit ready, we can help!

Featured Services

  • New Products Introductions
  • Regulatory Submissions
  • Design Control
  • Audit Ready Compliance Documentation
  • Quality System Readiness
  • PDA & ISO Quality System Training
  • Product Lifecycle Management

Call Today To Learn More About How We Can Help – 904.607.8569 (cell)

“ Wayner consistently uses her knowledge and Insight to provide simple solutions that helped navigate changing requirements. She has consistently been the voice of reason in complex,    difficult situations – bringing people together to find common solutions.”

– Scientist Fortune 500 Company

 

Wayner has put into practice… design control procedures… bringing business value… and successful audits which included FDA, ANVISA (Brazil) & BSI.”

– Vice President Medical Device Company

 

“Consistently used knowledge and insight to provide simple solutions that helped navigate changing requirements”

– Sr. Scientist Fortune 500 Company

 

 

“The voice of reason in complex, difficult situations – bringing people together to find common solutions”

– Scientist Fortune 500 Company

 

 

Contact Us

Phone: 904.607.8569

Email: Wayner@MD-PC.com