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MD & PC Mission Statement:

Delivering compliant, audit ready quality system documents and solutions that support new product introductions, regulatory submissions and global quality system requirements for the medical device and pharmaceutical industries

We couple our scientific training with a thorough knowledge of regulatory and quality system requirements to work with your cross functional new product teams to introduce new products.

Our focus is on helping your new product development teams implement the quality system requirements defined by 21 CFR 820, 210/211 and ISO 13485.We particularly specialize in assessing the status of yourdocument deliverables, making changes as appropriate and creating new design requirements documents, validation documents, design control deliverables and other quality system deliverables.

We use our leadership skills and our knowledge of the regulatory requirements as they pertain to new product development to work closely with your project teams to deliver timely new products to the marketplace.Whether your team is just starting and is looking for assistance in seamless integration of quality system requirements, in the middle of the process or at the end and need help in those final stages, we can help. Contact us today to see how we can help your new product teams deliver timely new products while simultaneously providing the supporting audit ready quality system documents required by global regulatory health authorities.

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