Quality Systems and Regulatory Affairs

Innovative Synergies International offers a variety of specialized quality and regulatory services, from the preparation and submission of FDA market clearance documentation (Pre-Market Approval (PMA) and Substantial Equivalence (510(k) submissions) to policies and procedures.

Services include:

• FDA submissions
• FDA foreign manufacturer representation
• Policy and procedure writing
• Training
• Other regulatory services

Our specialty is working with small medical device manufacturers to ensure that Quality System process and policy documentation is complete, clear, effective, and compliant with all of your company's internal and external requirements.

Contact us for more information. We'd be glad to discuss any upcoming projects you may have.

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