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Paladin Medical Inc.

P.O. Box 560
Stillwater, MN 55082-0560

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www.paladinmedical.com

About Paladin Medical Inc.

Paladin Medical®, Inc. provides efficient and effective medical device regulatory and development consulting to the medical device industry. We champion your new product through all phases of product development, testing and submissions to get your product to the market. Whether your project is a university spin-off, the star of a start-up company or a dedicated development project within a major corporation, our experience and expertise in all aspects of medical device quality and submissions will speed you on your way to success.

Products by Paladin Medical Inc.

By Paladin Medical Inc.

FDA Regulatory Pathways and Submission Types Some of the pathways to market you may not have heard much about. Special 510(K) Traditional 510(k) Abbreviated 510(k) PMA and PMA supplements HDE/HUD De Novo Combination Product – Read more in SPECIALTY SERVICES Investigational Device studies may... Read more »

By Paladin Medical Inc.

Design Control Reduce costs and time to market with efficient development systems All successful regulatory submissions are supported by FDA compliant Design Control and Review systems. Quality System Regulations (21 CFR 820 :QSRs) and ISO 13485 require documented design review according to... Read more »

By Paladin Medical Inc.

Qualification Planning and Testing requires coordination of the development of protocols with product claims, risk mitigation and performance requirements. Qualification planning pulls together Design Control compliance, regulatory submission requirements, such as development of claims,... Read more »

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