Your Champion for Product Success

Count on our experience to help you take your product to the market, Launching your new product requires a comprehensive strategic plan, Paladin Medical’s® expertise and commitment to high standards have resulted in countless successful product submissions and robust compliance training for our clients, Comprehensive strategic plan, regulatory assessment, marketing plans, FDA regulatory, submission, regulatory expertise

LAUNCH

Count on our experience to help you get to market

 Pre-clinical in-vitro and in-vivo (animal) studies must produce results that support product approval submissions and design validation, Our expertise in matching regulatory requirements and preclinical study plans makes Paladin Medical® an invaluable resource to your firm.

PRECLINICAL / CLINICAL

Assure your protocols will yield the evidence you need

 Reduce costs and time to market with efficient development systems. All successful regulatory submissions are supported by FDA compliant Design Control and Review systems.

DESIGN CONTROL

Reduce costs and time to market with development systems

 Not all new medical devices for the US Market require an application to FDA prior to marketing, Paladin Medical© will conduct a Regulatory Assessment to ascertain product classification and if your product may be exempt from submission, Paladin Medical® can help your company make the best determination on when a new submission is triggered. Our strategic planning and careful preparation can minimize delays and optimize your timetable

SUBMISSIONS

Prepare applications meeting up-to-date requirements including global strategies

 Qualification requires coordination of the intended product claims with risk mitigation, standards compliance, protocol development to substantiate performance requirements. Qualification Planning depends upon a comprehensive Hazard Analysis and Risk Assessment compliant with ISO 14971. Paladin Medical© works with your engineering team to integrate compliance with Design Controls compliance and documentation with requirements for regulatory submission deliverables. Verification and Validation is the bedrock for swift pre-market submissions

QUALIFICATION

Plan and execute performance studies with least burdensome methods

 Establish effective Quality Systems that work for your company. Paladin Medical® provides full life-cycle regulatory support

COMPLIANCE

Establish effective Quality Systems that work for your company
Paladin Medical Device Regulatory Services
 

Paladin Medical® Inc. offers a full range of medical device regulatory, clinical, and technical services for premarket applications and regulatory compliance. With our unprecedent expertise we assure you of regulatory compliance with the full range of Strategic Services. We work with your team to optimize your internal skills while providing solutions to your immediate requirements throughout the lifecycle of your products.

For more details about our many services and customized training, please contact us. Please connect with us on LinkedIn

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