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Regulatory/Quality Assurance Support

Regulatory
Regulatory submissions are critical to product success in the medical technology industries. HRG has the experience and access to resources that can assist clients with streamlining the regulatory process and developing accurate, complete submissions for FDA clearance. We are experienced in 510Ks, IDEs and PMAs.

Quality Assurance
A Quality system must meet the needs of your company, your products and your people while complying with the FDA's GMPs and the European Medical Device Directive. We have experience in the implementation and maintenance of Quality systems for both large and small companies. We can assist with your quality manual, detailed procedures and quality audits.


 

Email: info@horwathrg.com
Phone: 651-481-9734
Fax: 651-481-0278

Horwath Resource Group
4486 Timberline Court, Suite 100
Vadnais Heights, MN 55127


 
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