White papers from our practice, plus curated links to FDA, EU, and HCT/P regulatory references — the documents which we use every day, organized for easy access.
The same frameworks we use with clients, made available to the medical device community.
Management Review is often treated as a checkbox — but done right, it's the leadership-level lever that drives QMS effectiveness. Read this if your management reviews feel performative or your CAPA program isn't producing systemic improvement.
Download PDF → White PaperYour Quality Manual sets the architecture for everything that follows. Read this if you're standing up a new QMS, your existing manual was written years ago, or you've found yourself unable to explain how your system actually works.
Download PDF → White PaperA practical roadmap for the FDA's harmonization with ISO 13485 — timelines, gaps, and priorities. Read this if you're planning your QMSR transition or assessing the gap between your current QMS and the new requirements.
Download PDF → White PaperA QMS isn't just a compliance obligation — it's a strategic asset when it's the right size for your company and built to drive continuous improvement. Read this if you're evaluating an off-the-shelf QMS solution, questioning whether your current system still fits your operations, or want to make the case internally for investing in your QMS.
Download PDF → BrochureOur complete service offering, principal credentials, and engagement models in a single shareable PDF. Read this if you're evaluating consulting partners, building a budget for an upcoming program, or need to introduce Novare to your leadership team.
Download PDF →Foundational FDA documents and guidance for US medical device companies.
Core European regulatory documents for the medical device market.
References for human cell, tissue, and cellular and tissue-based product establishments.
Core ISO Standards for medical device companies.
Schedule a no-cost consultation. We work in these documents every day and can help you navigate what applies to your products and markets.
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