QUALITY REGULATORY TOXICOLOGY

Medical Device Consulting

Customized solutions for your Business Strategy

We help small to mid-sized Medical Device businesses meet the latest compliance standards while attaining business strategies

Our team evaluates your business strategy, understands your market, and current compliance program, we identify areas for improvement and provide customized solutions. QRTs’ hands-on approach ensures that your business operations and facilities will have a pathway to compliance success and business growth.
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Regulatory Compliance

Are you looking to purchase a Medical Device business? Don’t underestimate the cost of quality in your operations assessment.  Underestimating the risk can be a costly future investment. 

Quality Management System

QRT works collaboratively with clients to guide quality management strategies. Our team possesses the experience to devise customized solutions to develop a quality system that supports compliance.

Risk Management

Medical Device businesses are also expected to be compliant with local and Federal regulations (US FDA 21 CFR 820, EU MDR), and also rise to the ISO standards (13485, 14971, 10993).

Mergers & Acquisition

The mergers occurring in the life sciences industry have generated an unprecedented amount of activity, resulting in hundreds of billions of dollars in transactions.

Quality medical devices for healthcare professionals and patients depends on factoring regulatory standards into the manufacturing process.  QRT Consulting Group provides the compliance knowledge and insights necessary to ensure safety and quality are maintained in your processes.